Patients must not have a condition requiring systemic corticosteroids equivalent to > 10 mg prednisone per day or other immunosuppressive medications within 2 weeks of randomization; inhaled, intra-articular, and epidural steroids are permissible
No ongoing therapy with corticosteroids greater than 10 mg of prednisone or its equivalent per day; please note: inhaled and topical steroids are permitted
Patient requires systemic, pharmacologic doses of corticosteroids (equivalent to >30 mg hydrocortisone/day) Note: Replacement doses (equivalent to ? 5 mg prednisone/day), and topical, ophthalmic, and inhalation steroids are permitted as needed
Treatment with systemic corticosteroids >20 mg/day, prednisone or equivalent
Subject currently using or have received immunosuppressive medications within 14 days prior to the first dose of KHK2455, with the exception of topical or systemic corticosteroids that are not to exceed 10 mg/day of prednisone or equivalent;
Any immunomodulatory drug therapy, anti-neoplastic hormonal therapy (unless dose has been stable for 3 months prior to Baseline and will remain stable during the trial), immunosuppressive therapy, corticosteroids >20 mg/day prednisone or equivalent, or growth factor treatment (e.g., erythropoietin) within 14 days prior to initiation of study drug.
Any prednisone (or equivalent corticosteroids) use within 2 weeks of study entry
Participants taking corticosteroids (>= 10 mg of prednisone or equivalent). Exceptions may be discussed with the overall principal investigator (PI) on a case by case basis
Treatment with systemic corticosteroids ? 20 mg/day prednisone or equivalent, for non-lymphoma treatment reasons. For lower acceptable doses, documentation of a stable dose for at least 4 weeks prior to Day 1 of Cycle 1 is required.
Must not have required immunosuppressive agents, other than corticosteroids for the management of an adverse event and not currently requite maintenance doses of >10 milligrams (mg) prednisone (or equivalent) per day.
Any other concurrent investigational agent or chemotherapy, radiotherapy, immunotherapy, or corticosteroids (prednisone up to 20 mg/day or its equivalent is permitted for chronic conditions)
Need of more than 10 mg/day of prednisone or an equivalent dose of other anti-inflammatory corticosteroids as a current systemic corticosteroid therapy to treat a chronic disease (e.g., rheumatic disorder)
TREATMENT EXCLUSION: Current use of systemic corticosteroids at a dose equivalent to 0.5 mg/kg/day of prednisone or higher
Previously untreated; NOTE: this includes any chemotherapy or immunotherapy or RIT; patients who received corticosteroids for diseases other than lymphoma are eligible as long as prednisone dose is =< 10 mg/day
Systemic corticosteroids greater than the equivalent of 10 mg of prednisone per day within 4 weeks of study drug administration are prohibited
Prior to the start of voruciclib therapy, subjects may be using systemic corticosteroids (?20 mg/day of prednisone or equivalent), topical, or inhaled corticosteroids
Immunosuppressive treatments within 4 weeks prior to embolization, unless prednisone ? 5 mg or equivalent
Chronic use of corticosteroids in excess of prednisone 20 mg/day or its equivalent
The subject is off corticosteroids of > 10 mg/day prednisone or equivalent.
No concurrent treatment for the CNS disease (e.g. surgery, radiation, corticosteroids >10 mg prednisone/day or equivalent)
Treatment with systemic corticosteroids (> 10 mg per day prednisone or equivalent) or other immune suppressive drugs within 2 weeks
Received a cumulative dose of corticosteroids equivalent to greater than or equal to ( >=) 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug
Systemic corticosteroid therapy within 7 days before enrollment. Note: Topical and inhaled corticosteroids in standard doses and physiologic replacement for subjects with adrenal insufficiency are allowed. ? 5 mg/day of prednisone or equivalent doses of other corticosteroids are not allowed.
If patient is currently on prednisone or other corticosteroids for palliation, the dose must be less than or equal to 10 mg a day or its equivalent dose and it must have been started at least 4 weeks prior to cycle 1 day 1
Systemic therapy with corticosteroids at >20 mg/day prednisone or equivalent within 1 week prior to the first dose of study drug
Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 on stable or reducing dose of steroids for symptom management (not more than 8 mg of dexamethasone or equivalent per day) for 5 days prior to enrollment; change in glucocorticoid dose for any purpose other than to modulate symptoms from an adverse event; Note: The use of physiologic doses (e.g., prednisone 10 mg) of corticosteroids may be approved after consultation with Merck & Co; use of prophylactic corticosteroids to avoid allergic reactions (e.g. IV contrast dye) is permitted
Corticosteroid use =< 14 days prior to registration; NOTE: Patients must be off systemic corticosteroids for at least 2 weeks prior to registration; this includes oral or IV route of administration; patients on chronic corticosteroids for adrenal insufficiency or other reasons may enroll if they receive less than 10 mg/day of prednisone (or equivalent); patients receiving inhaled or intranasal or intra-articular steroids are not excluded
Concomitant use of systemic corticosteroids at physiologic doses or > 10 mg/day of prednisone or equivalent
Need for current chronic corticosteroid therapy (>= 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids)
Concurrent treatment with systemic corticosteroids (prednisone dose > 10 mg per day or equivalent) or other immunosuppressive drugs < 14 days prior to treatment initiation. Steroids that are topical, inhaled, nasal (spray), or ophthalmic solution are permitted.
Received a cumulative dose of corticosteroids equivalent to greater than or equal to (>=) 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug
Current use of corticosteroid therapy > 5 mg/day of prednisone or equivalent doses of other corticosteroids (topical, intranasal, and inhaled corticosteroids in standard doses and physiologic replacement for subjects with adrenal insufficiency are allowed)
Subject has received a cumulative dose of corticosteroids more than the equivalent of >= 140 mg of prednisone within the 2 week period before cycle 1, day 1
Patients must not take corticosteroids including prednisone, dexamethasone or any other corticosteroid for 14 days before apheresis and CAR T-cell infusion; patients must also not take corticosteroids at doses higher than 5 mg/day of prednisone or equivalent at any time after the CAR T cell infusion
Patients receiving chronic, high dose systemic treatment with corticosteroids defined as: chronic use of cortisone > 50mg; hydrocortisone > 40mg, prednisone > 10mg, methylprednisone > 8mg or dexamethasone > 1.5mg; or another immunosuppressive agent; topical or inhaled corticosteroids are allowed
Subjects requiring escalating or chronic supraphysiologic doses of corticosteroids (> 10 mg/d of prednisone equivalent) for control of disease at the time of registration
Therapeutic doses of corticosteroids (defined as >20 mg/day prednisone or equivalent) within 7 days of leukapheresis or 72 hours prior to JCAR017 administration. Physiologic replacement, topical, and inhaled steroids are permitted.
CELL PROCUREMENT: Prior to procurement current use of systemic corticosteroids at doses >= 10mg/day prednisone or its equivalent; those receiving < 10mg/day may be enrolled at discretion of investigator; (Note: corticosteroid use with doses at the discretion of the treating physician are allowed after procurement up to the beginning of lymphodepletion; corticosteroid use is contraindicated following iC9-CAR19 infusion unless medically necessary e.g., to treat CRS)\r\n* Physiologic replacement with hydrocortisone is allowed at doses 6-12 mg/m^2/day, or equivalent
LYMPHODEPLETION: Use of systemic corticosteroids at doses >= 10mg/day prednisone or its equivalent; those receiving < 10mg/day may be enrolled at discretion of investigator; (Note: Corticosteroid use with doses at the discretion of the treating physician are allowed after procurement up to the beginning of lymphodepletion)\r\n* Physiologic replacement with hydrocortisone is allowed at 6-12 mg/m2/day, or equivalent
Chronic use of corticosteroids in excess of prednisone 30 mg/day or its equivalent
Has received the following within 7 days prior to study day 1:\r\n* Allergy desensitization injections\r\n* Systemic corticosteroids of more than 10 mg per day of prednisone (or equivalent), and administered parenterally or orally, except for physiologic replacement; inhaled steroids (e.g. Advair, Flovent, Azmacort) are not permitted; topical corticosteroids are acceptable, including steroids with very low solubility administered nasally for local effects only (e.g. Nasonex)
Therapeutic doses of corticosteroids within 14 days prior to study entry, defined as > 20 mg/day of prednisone, or equivalent; topical and/or inhaled steroids are permitted
Concomitant disease which requires continuous therapy with corticosteroids at doses equivalent to prednisolone >20 mg/day.
Must not have required the use of additional immunosuppressive agents other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of >10 milligrams prednisone or equivalent per day.
Chronic use (> 2 weeks) of corticosteroids (prednisone >= 10 mg/24 hour [hr] equivalent) within 4 weeks of screening
Planned use of corticosteroids (> 10 mg/day prednisone or equivalent) or other systemic immunosuppression within 4 days prior to leukapheresis; topical and/or inhaled steroids are permitted
Planned use of corticosteroids (> 10 mg/day prednisone or equivalent) or other systemic immunosuppression is not permitted within 72 hours prior to JCAR014 infusion; topical and/or inhaled steroids are permitted.
The use of corticosteroids to control cerebral edema or treat neurologic symptoms will not be allowed, and patients who previously required corticosteroids for symptom control must be off steroids for at least 2 weeks; low-dose steroid use (=< 10 mg of prednisone or equivalent) as corticosteroid replacement therapy is allowed
Patients must not take corticosteroids including prednisone, dexamethasone or any other corticosteroid for 14 days before apheresis and CAR T-cell infusion; patients must also not take corticosteroids at doses higher than 5 mg/day of prednisone or equivalent at any time after the CAR T cell infusion
Unstable, symptomatic brain metastases; Note: participants whose symptoms are controlled on a stable dose of corticosteroids (=< 20 mg prednisone equivalent per day) for at least 2 weeks will be eligible
Other concurrent immunotherapy (eg, immunosuppressants or chronic use of systemic corticosteroids, with the exception that low-dose corticosteroids [50 mg/day prednisone or equivalent corticosteroid] are allowed; these should be discussed with the Medical Monitor)
Must not have a concurrent medical condition requiring use of systemic corticosteroids with prednisone > 10 mg per day
Systemic corticosteroids < 1 week prior to Day 1 in Phase 1a. Subjects may receive stable physiologic replacement doses of glucocorticoids (up to the equivalent of 10 mg daily prednisone) as maintenance therapy for adrenal insufficiency.
Concurrent use of corticosteroids equivalent of prednisone at a dose > 0.5 mg/kg
Receiving corticosteroids > 20 mg of prednisone per day (or equivalent); Note: the dose should be noted on the medication record each cycle
Dependence on corticosteroids\r\n* Steroid dependence can be defined as a medical need to be greater than 5 mg of prednisone (or equivalent doses of other systemic steroids) a day, chronically; higher doses need to be avoided for at least 3 days prior to leukapheresis and, again, for at least 3 days prior to T cell infusion and up to at least 3 months after T cell infusion unless medically indicated to treat a new toxicity\r\n* Note: topical and inhaled corticosteroids in standard doses and physiologic replacement for subjects with adrenal insufficiency are allowed
Dependence on corticosteroids\r\n* Defined as doses of corticosteroids of greater than 5 mg/day of prednisone or equivalent doses of other corticosteroids\r\n* Note: topical and inhaled corticosteroids in standard doses and physiologic replacement for subjects with adrenal insufficiency are allowed\r\n* Please note that this criterion is not applicable if the research participant's donor is undergoing leukapheresis
Receipt of systemic cancer therapy, immunomodulatory drug therapy, immunosuppressive therapy, or corticosteroids > 20 mg/day prednisone or equivalent within 14 days prior to the Baseline Visit or concurrently during the trial.
Patients who are currently receiving chronic (> 14 days) treatment with corticosteroids at a dose >= 10 mg of prednisone (or its glucocorticoid equivalent) per day, or any other chronic immunosuppressive treatment that cannot be discontinued prior to starting study drug
The use of corticosteroids to control cerebral edema or treat neurologic symptoms will not be allowed, and patients who previously required corticosteroids for symptom control must be off steroids for at least 2 weeks; low-dose steroid use (=< 10 mg of prednisone or equivalent) as corticosteroid replacement therapy is allowed
Regular treatment with corticosteroids during the 4 weeks prior to the start of cycle 1, unless administered for indications other than NHL at a dose equivalent to =< 30 mg/day prednisone
Medical condition requiring chronic use of high dose systemic corticosteroids (i.e., doses of prednisone higher than 10 mg/day or equivalent)
Able to be off of corticosteroids and any other immune suppressive medications beginning on day -3 and continuing until 30 days after the infusion of the CIML NK cells; however, use of low-level corticosteroids is permitted if deemed medically necessary; low-level corticosteroid use is defined as 10 mg or less of prednisone (or equivalent for other steroids) per day
If receiving corticosteroids, ? 20 mg/day prednisone or equivalent and unchanged
Have not received any leukemia treatment within 1 week prior to starting study drug; corticosteroids up to 20 mg of prednisone (or equivalent) is allowable throughout the study; doses > 20 mg prednisone (or equivalent) are NOT permitted; doses of steroids =< 20 mg of prednisone (or equivalent) are permitted; hydroxyurea is allowed prior to enrollment and after the start of the study drug for the control of peripheral leukemic blasts in subjects with leukocytosis per physician discretion
Receiving corticosteroids above physiological dosing (> 5 mg per day of prednisone) within 28 days prior to anti-CD19-CAR-transduced T cell administration
Subject has received systemic immunosuppressive therapy, including systemic corticosteroids within 14 days prior to first dose of study treatment. Subjects using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone) are allowed.
Concurrent need of use of corticosteroids > 10 mg/day of oral prednisone or the equivalent, except topical preparations (e.g., topical creams, steroid inhaler, nasal spray or ophthalmic solution);
Patients on systemic corticosteroids (>10 mg prednisone per day or equivalent) or other systemic immunosuppressive drugs
Chronic use (>2 weeks) of greater than physiologic doses of corticosteroid agent (dose equivalent to ?10mg of prednisone) within 28 days of 1st day of study drug treatment & during treatment
Systemic corticosteroids at physiologic doses ?10 mg/day of prednisone or equivalent are permitted;
Chronic treatment for more than 6 months with systemic corticosteroids at doses above 10 mg prednisolone or equivalent before study entry
Short course systemic corticosteroids for disease control, improvement of performance status or non-cancer indication within 7 days prior to day 1 of protocol therapy; stable ongoing corticosteroid use (i.e. at least 30 days) up to an equivalent dose of 20 mg of prednisone is permissible
Chronic use of corticosteroids in excess of prednisone 20 mg/day or its equivalent
Have received a cumulative dose of corticosteroid ? 150 mg prednisone (or equivalent doses of corticosteroids) within two weeks before the first Investigational Medicinal Product (IMP) administration.
Evidence of clinically significant immunosuppression such as the following:\r\n* Primary immunodeficiency state such as severe combined immunodeficiency disease\r\n* Receiving systemic immunosuppressive therapy including prednisone > 10 mg per day (or equivalent), tacrolimus, everolimus, sirolimus, mycophenolate mofetil, etanercept, infliximab, etc. \r\n* Recipients of solid organ, bone marrow, or stem cell transplants; auto transplant recipients are allowed\r\n* Notes: Oral steroid doses =< 10 mg/day of prednisone (or equivalent) are not considered immunosuppressive and are permitted; inhaled and intraarticular corticosteroids are permitted
Treatment with corticosteroids (?10 mg per day prednisone or equivalent) or other immune suppressive drugs within the 14 days prior to the initiation of study drug administration.
Ongoing corticosteroids for indications other than multiple myeloma allowed as long as the dose does not exceed 10 mg of prednisone per day or equivalent
DOSE ESCALATION COHORT: Subjects who are receiving an immunosuppressive treatment for any reason, including chronic use of systemic steroid or prednisone equivalent at doses ? 10 mg/day within 14 days prior to the first dose of study treatment; use of inhaled or topical steroids or systemic corticosteroids < 10 mg is permitted
DOSE EXPANSION COHORT: Subjects who are receiving an immunosuppressive treatment for any reason, including chronic use of systemic steroid or prednisone equivalent at doses ? 10 mg/day within 14 days prior to the first dose of study treatment; use of inhaled or topical steroids or systemic corticosteroids < 10 mg is permitted
Requires escalating or chronic supraphysiologic doses of corticosteroids (> 10 mg/day prednisone equivalents)
Chronic use of corticosteroids in excess of prednisone 20 mg/day or its equivalent
Chronic use (? 2 weeks) of corticosteroids (? 10 mg/24 hour equivalent prednisone) within 4 weeks of Baseline/Cycle 1 Day 1 visit.
History of severe asthma, as defined by prior or current use of systemic corticosteroids for disease control, with the exception of physiological replacement doses of cortisone acetate or equivalent, as defined by a dose of 10 mg or less
Patients with a history of severe immune-mediated adverse reactions with ipilimumab: this will be defined as any grade 4 toxicity requiring treatment with corticosteroids (greater than 10 mg/day prednisone or equivalent dose) for greater than 12 weeks
Patients should not take corticosteroids including prednisone, dexamethasone or any other corticosteroid for any purpose at doses higher than 5 mg/day of prednisone or equivalent dose of another corticosteroid 2 weeks before apheresis and within 2 weeks prior to CAR T-cell infusion, and at any time after the CAR T cell infusion
Concurrent systemic immunosuppressive therapy or steroid therapy with more than 7 consecutive days of steroids within the last 4 weeks\r\n* The use of prednisone or equivalent < 0.125 mg/kg/day (absolute maximum of 10 mg/day) as replacement therapy is permitted\r\n* Inhaled corticosteroids are permitted\r\n* The following will not be exclusionary:\r\n** The presence of laboratory evidence of autoimmune disease (e.g. positive antinuclear antibody [ANA] titer) without associated symptoms\r\n** Mild Raynaud’s phenomenon\r\n** History of severe asthma, as defined by prior or current use of systemic corticosteroids for disease control, with the exception of physiological replacement doses of cortisone acetate or equivalent, as defined by a dose of prednisone or equivalent of 10 mg or less
Systemic corticosteroids within 2 weeks, except low dose regimens (prednisone, ? 20\n             mg/day, or equivalent) which may continue if unchanged
Current treatment or treatment within 4 weeks of screening with drugs known to reduce\n             serum calcium levels, including: bisphosphonates, antiepileptic drugs, cinacalcet,\n             macrolide antibiotics (such as erythromycin, azithromycin), large doses of\n             corticosteroids (>20 mg/day of prednisone or equivalent), or any IV use of\n             corticosteroids. In addition, long-term use (defined as ongoing use for ?4 weeks) of\n             corticosteroids within 8 weeks of screening is prohibited
No corticosteroids are permitted, except for maintenance therapy for a non-malignant disease or to prevent treatment-related ofatumumab reactions (maintenance therapy dose must not exceed 20 mg/day prednisone or equivalent)
Prior systemic glucocorticosteroid use for the treatment of non-malignant disorders is permitted; concurrent use after registration on the study should be restricted to the equivalent of prednisone 10 mg per day
Systemic therapy with corticosteroids at >20 mg/day prednisone or equivalent within 1 week prior to the first dose of study drug
Requires treatment with high dose systemic corticosteroids defined as >2 mg/day
Patients receiving corticosteroids for any indication within 7 days before the onset of acute GVHD, except the following: Stable replacement doses of corticosteroids for adrenal insufficiency are permitted (e.g. hydrocortisone total dose of 10-12 mg/m^2/day or prednisone 5-7.5mg daily or equivalent). Corticosteroids administered as premedication before transfusion of blood products or before intravenous medications to prevent infusion reactions are allowed.
Regular dose of corticosteroids the 28 days prior to Day 1 of this study or anticipated need for corticosteroids that exceeds prednisone 10 mg/day or equivalent within 28 days prior to the first RO6958688 infusion. Inhaled and topical steroids are permitted
Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent;
Need for current chronic corticosteroid therapy (>=10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids)
Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent
Regular treatment with corticosteroids within the 2 or 4 weeks prior to the start of Cycle 1, unless administered for indications other than non-Hodgkin's lymphoma at a dose equivalent to < 30 mg/day prednisone/prednisolone
Chronic use (? 2 weeks) of corticosteroids (? 10 mg/24 hr equivalent prednisone) within 4 weeks of Baseline/First Dose.
Received any chemotherapy, immunomodulatory or immunosuppressive therapy, corticosteroids (greater than [>]30 milligram per day [mg/day] prednisone or equivalent) within 28 days prior to randomization
Requirement for chronic immunosuppressive medication including systemic corticosteroids above the physiologic dose (30 mg/day hydrocortisone or the equivalent).
Patients receiving concomitant immunosuppressive agents or chronic corticosteroids (?10 mg of prednisone or equivalent) at the time of first study dose.
Patients who are currently receiving chronic (> 14 days) treatment with corticosteroids at a dose equal to or more than 10 mg of prednisone (or its glucocorticoid equivalent) per day, or any other chronic immunosuppressive treatment that cannot be discontinued prior to starting study drug
Requires escalating or chronic supraphysiologic doses of corticosteroids (> 10 mg/day prednisone equivalents)
Have received a cumulative dose of corticosteroid ? 100 mg (prednisone or equivalent doses of corticosteroids) within two weeks before the first infusion.
Subjects taking corticosteroids during the last week prior to study treatment, unless administered at a dose equivalent to < 20 mg/day prednisone or prednisolone.
Have received corticosteroids greater than (>) 30 milligram per day (mg/day) prednisone or equivalent, or growth factor treatment within 4 weeks prior to study entry
Chronic systemic corticosteroid use (ie, prednisone > 10 mg QD or the equivalent); treatment for well-controlled and asymptomatic adrenal insufficiency is permitted, but replacement dosing is limited to prednisone ? 10 mg QD or the equivalent, and patients must have no history of adrenal crisis. Local steroid therapies (eg, otic, ophthalmic, intra-articular or inhaled medications) are acceptable
Medical condition requiring chronic use of high dose systemic corticosteroids (i.e., doses of prednisone higher than 10 mg/day or equivalent); brief (< 15 days) treatment with glucocorticoids (prednisone 100 mg by mouth daily, or equivalent) is acceptable
Concurrent treatment with anti -Tumor necrosis factor (TNF) alpha therapies, systemic corticosteroids (prednisone dose >10 mg per day or equivalent) or other immune suppressive drugs within the 2 weeks prior to Screening. Steroids that are topical, inhaled, nasal (spray), or ophthalmic solution are permitted
Other ongoing or prior anti-myeloma therapy; patients may be receiving concomitant therapy with bisphosphonates and low dose corticosteroids (e.g., prednisone up to but no more than 10 mg p.o. q.d. or its equivalent) for symptom management and comorbid conditions; doses of corticosteroid should be stable for at least 7 days prior to study treatment)
Short course systemic corticosteroids for disease control, improvement of performance status or non-cancer indication (=< 7 days) must have been discontinued at least 6 days prior to study treatment; stable ongoing corticosteroid use (>= 30 days) up to an equivalent dose of 15 mg of prednisone is permissible\r\n* Topical steroids that have been used for > 3 weeks may be continued (CTCL only)
Concurrent therapy with approved or investigational anticancer therapeutic; patients are allowed to receive corticosteroids for the treatment of non-malignant disorders in doses not to exceed the equivalent of prednisone 20 mg/day
Participants using concomitant corticosteroids are allowed as long as the subject is on the equivalent of 20 mg/day or less of prednisone and has been on a stable dose for at least two weeks prior to initiating therapy
Dependence on corticosteroids\r\n* Defined as doses of corticosteroids of greater than or equal to 5 mg/day of prednisone or equivalent doses of other corticosteroids\r\n* Note: topical and inhaled corticosteroids in standard doses and physiologic replacement for subjects with adrenal insufficiency are allowed
Other ongoing anti-myeloma therapy; patients may be receiving concomitant therapy with bisphosphonates and low dose corticosteroids (e.g., prednisone up to but no more than 10 mg p.o. q.d. or its equivalent) for symptom management and comorbid conditions; doses of corticosteroid should be stable for at least 7 days prior to study treatment)
Use of systemic corticosteroids equivalent to prednisone 10 mg/day or higher at the time of study entry (inhaled corticosteroids are permitted)
Therapeutic doses of corticosteroids (defined as > 20 mg/day prednisone or equivalent) within 7 days prior to leukapheresis
Chronic systemic corticosteroid use at supraphysiologic doses (>= 10 mg prednisone per day or equivalent)
Short course systemic corticosteroids for disease control, improvement of performance status or non-cancer indication (< 7 days) must have been discontinued at least 7 days prior to study treatment; stable ongoing corticosteroid use (>= 30 days) up to an equivalent dose of 15 mg of prednisone is permissible
Current treatment with immunosuppressive agents other than prescribed corticosteroids (not more than 10-mg prednisone equivalent).
Oral corticosteroids >= 7.5 mg/day prednisone (or prednisone equivalents)
No medical condition requiring chronic use of high dose systemic corticosteroids (i.e., doses of prednisone higher than 10 mg/day or equivalent)
Patient on corticosteroids within two weeks prior to study entry, except for prednisone < = 10 mg/day or equivalent for purposes other than treating MCL.
Receiving chronic therapy for more than 10 days at doses of prednisone greater than 10 mg/day (or equivalent) at the moment of the inclusion. Inhaled and topical corticosteroids are allowed.
No MF-directed treatment for at least 2 weeks prior to initiation of NS-018, including any use of corticosteroids for Myelofibrosis symptom or blood count management. Low dose corticosteroids ? 10 mg/day prednisone or equivalent is allowed for non-myelofibrosis purposes.
Systemic corticosteroids (e.g. prednisone >= 12.5 mg/day or dexamethasone >= 2 mg/day) for the purpose of palliating tumor-related symptoms will not be allowed within 1 week of starting treatment on trial
Patients cannot have evidence of immunosuppression or have been treated with immunosuppressive therapy, such as chemotherapy or chronic treatment dose corticosteroids (greater than the equivalent of 10 mg prednisone per day), within 6 months of the first vaccination; treatment or salvage radiation therapy must have been completed at least 4 weeks prior to the first vaccination
Receiving corticosteroids > 20 mg of prednisone per day (or equivalent)
Concurrent and chronic therapy with corticosteroids (greater than 10mg per day of prednisone or an equipotent dose of another corticosteroid) or any other immunosuppressive drugs
For Post-allo Part B: Concurrent use of corticosteroids equivalent of prednisone at a dose of greater than 0.5 mg/kg
Chronic use of systemic corticosteroids (i.e., >= 10 mg/day prednisone or equivalent)
Current use of systemic corticosteroids (> 5 mg prednisone)
Receipt of corticosteroids > 20 mg/day within 4 weeks prior to1st dose
Currently receiving increasing or chronic treatment ( > 5 days) with corticosteroids (e.g. dexamethasone > 4 mg/day or other corticosteroids equivalent dose) or another immunosuppressive agent.
Receipt of systemic corticosteroids within 3 weeks of study treatment, unless patient has been taking a continuous dose of 10 mg/day or less of oral prednisone or equivalent for at least 4 weeks or as part of a CHOP prednisone taper.
Patients must be off corticosteroids for at least 2 weeks prior to registration; this includes oral, intravenous (IV), subcutaneous, or inhaled route of administration; patients on chronic corticosteroid for adrenal insufficiency or other reasons may enroll if they receive less than 10 mg/day of prednisone (or equivalent)
Has, within 2 weeks prior to Day 1, received systemic corticosteroids exceeding prednisone 10 mg per day or equivalent; for other immunosuppressive agents, the exclusionary dose and duration will be determined in consultation with the Medical Monitor.
Need for current chronic corticosteroid therapy (>= 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids)
Use of systemic corticosteroids in doses greater than prednisone equivalent to 20 mg/day.
Current use of corticosteroids; EXCEPTION: low doses of steroids (=< 10 mg of prednisone or equivalent dose of other steroid) used for treatment of nonhematologic medical conditions; NOTE: previous use of corticosteroids is allowed
if receiving corticosteroids, patients must have been on a stable or decreasing dose of corticosteroids and no more than 1 mg of dexamethasone a day or equivalent, i.e. 6 mg prednisone or 25 mg hydrocortisone for at least 5 days prior to date of enrollment.
Patient requiring systemic, pharmacologic doses of corticosteroids (equivalent to > 60 mg hydrocortisone/day or 2 mg dexamethasone/day). Replacement doses (equivalent to ? 5 mg prednisone/day), and topical, ophthalmic, and inhalation steroids are permitted as needed.
Patient requires systemic, pharmacologic doses of corticosteroids (equivalent to > 60 mg hydrocortisone/day or 2 mg dexamethasone/day). Replacement doses (equivalent to ? 5 mg prednisone/day), and topical, ophthalmic, and inhalation steroids are permitted as needed.
Have received a cumulative dose of corticosteroid ? 150 mg (prednisone or equivalent doses of corticosteroids) within two weeks before the first infusion.
Low-dose corticosteroids (prednisone <20 mg/ day or equivalent dose) are permitted throughout study.
High-dose corticosteroids (prednisone ?20mg/day or equivalent dose) must be discontinued ? 7 days of initiating therapy.
Subject has received a cumulative dose of corticosteroids more than the equivalent of >= 140 mg of prednisone within the 2–week period before cycle 1, day 1
Need for chronic corticosteroid therapy of >=10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressants for a chronic disease
Daily requirement for corticosteroids (except for inhalational corticosteroids); prednisone =< 10mg/day or equivalent is permitted for other medical conditions
The patient requires concomitant treatment with systemic corticosteroids or any other immunosuppressive agents. The use of prednisone, or equivalent, <0.5 mg/kg/day (absolute maximum 40 mg/day), or inhaled corticosteroids or topical steroids is permitted.
Regular treatment with corticosteroids within the 4 weeks prior to the start of Cycle 1, unless administered for indications other than NHL at a dose equivalent to < 30 mg/day prednisone/prednisolone
Concurrent treatment with systemic corticosteroids (prednisone dose > 10 mg per day or equivalent) or other immunosuppressive drugs < 14 days prior to treatment initiation; steroids that are topical, inhaled, nasal (spray), or ophthalmic solution are permitted
Receipt of corticosteroids within 7 days prior to the first dose of study treatment, unless patient has been taking a continuous dose of no more than 15 mg/day of prednisone or equivalent for at least 1 month prior to first dose of study treatment; low dose steroid use for the control of nausea and vomiting, topical steroid use and inhaled steroids are permitted
Subjects with a condition requiring systemic treatment with systemic corticosteroids (equivalent of > 10 mg/day of prednisone); patients may receive steroid therapy up to 10 days prior to starting ABVD to control lymphoma-related symptoms
Subjects requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses =< 10 mg or 10 mg equivalent prednisone per day
Concurrent treatment with anti-Tumor necrosis factor alpha (TNF alpha) therapies, systemic corticosteroids (prednisone dose greater than [>]10 mg per day or equivalent) or other immune suppressive drugs within the 2 weeks prior to Screening. Steroids that are topical, inhaled, nasal (spray) or ophthalmic solution are permitted
Current use of systemic corticosteroids at doses > 10mg/day prednisone or its equivalent; those receiving =< 10mg may be enrolled at discretion of investigator
Ongoing treatment with corticosteroids with a dose >10 milligram (mg) prednisone or equivalent per day at the time of randomization; or >280 mg cumulative prednisone dose or equivalent for any 4-week period in the year prior to randomization
Treatment with systemic immune modulators including, but not limited to, nontopical systemic corticosteroids (unless the dose is ? 10 mg/day prednisone or equivalent), cyclosporine, and tacrolimus within 2 weeks before study day 1
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone greater than or equal to 20 mg/day, or equivalent. Inhaled and topical steroids are allowed
Patients on established, chronic corticosteroid therapy (> 5 mg /day of prednisone or prednisone equivalent) prior to transplant; established, chronic corticosteroid therapy is defined as daily dosing of > 5 mg/day of prednisone or prednisone equivalent for at least 2 weeks prior to the start of conditioning/chemotherapy or plans to continue pre-transplant corticosteroids (> 5 mg/day of prednisone or prednisone equivalent) indefinitely after transplantation
Corticosteroids are allowed, but must be dosed at prednisone 20 mg (or equivalent) or lower prior to the start of chemotherapy
Chronic daily treatment with corticosteroids with a dose of >= 10 mg/day methylprednisolone equivalent (excluding inhaled steroids)
Patients with resected or irradiated brain metastases or those treated with stereotactic radiation therapy are eligible to enroll, provided that they do not require treatment with steroids that exceeds 10 mg of prednisone daily or equivalent
Daily steroids of > 0.5 mg/kg prednisone or glucocorticoid equivalent, methotrexate, or extracorporeal photopheresis
Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic steroids > 20 mg of prednisone (or equivalent) once daily (QD)
Chronic use of corticosteroids more than 10mg daily prednisone equivalent during the past 4 weeks prior to planned start of MM-310
Ongoing chronic systemic steroid therapy required (>10 mg oral prednisone daily or equivalent)
Physiologic doses of corticosteroids are permitted (i.e., no more than 10 mg of prednisone daily)
Patients requiring chronic high dose immunosuppressants including steroids (prednisone daily equivalent of >= 10 mg)
Daily requirement for corticosteroids (> 10 mg prednisone once daily [QD] or equivalent)
Any chronic medical condition requiring a higher dose of corticosteroid than equivalent of 5 mg prednisone/prednisolone once daily
No requirement of > 0.5 mg/kg of prednisone (or equivalent) daily dose within 1 week of randomization
Patient receives chronic steroid use > 10 mg prednisone (or steroid equivalent) daily
Concomitant corticosteroids unless patient has been on a stable dose of prednisone (or equivalent) of =< 10 mg daily for at least 2 weeks prior to first dose of study drug
Receiving steroids > the equivalent of 10 mg prednisone daily for other medical conditions, e.g., asthma, systemic lupus erythematosis, rheumatoid arthritis
Must be on =< 20 mg of oral daily prednisone or equivalent for GVHD
Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study; patients may be receiving concomitant therapy with bisphosphonates and low dose corticosteroids (e.g., prednisone up to but no more than 10 mg by mouth daily or its equivalent) for symptom management and comorbid conditions; doses of corticosteroid should be stable for at least 7 days prior to study treatment
Pre-existing condition that warrants long-term corticosteroid use in excess of 10 mg prednisone/prednisolone daily. (Note: If a subject has been receiving glucocorticoids other than prednisone or prednisolone, it will be necessary to switch the glucocorticoids to prednisone or prednisolone 5 mg twice daily prior to day 1)
Steroid doses greater than an equivalent of prednisone 10 mg daily
Subject is receiving systemic steroids at doses greater than the equivalent of prednisone 10 mg daily, with the exception of intermittent use for the treatment of emesis
Receiving systemic steroid therapy of > 10 mg prednisone daily or equivalent\r\n* Note:\r\n** Corticosteroid use on study after cycle 1 for management of adverse events, serious adverse events, and events of clinical interest, as a premedication for IV contrast allergies/reactions, or if considered necessary for a subject’s welfare is\r\nallowed\r\n** Subjects who receive daily steroid replacement therapy are an exception; daily prednisone at doses of 5 to 7.5 mg is an example of replacement therapy\r\n** Equivalent hydrocortisone doses are also permitted if administered as replacement therapy
Requirement for corticosteroids greater than the equivalent of 10 mg of prednisone daily for more than 2 weeks.
Medical history of autoimmune disease (e.g. Crohn’s disease, ulcerative colitis) or other disease requiring systemic glucocorticoid or immunosuppressive therapy; subjects who receive daily steroid replacement therapy serve as an exception to this rule; daily prednisone equivalent at doses up to 10 mg would qualify
Concurrent immunosuppressive therapy. A stable dose of prednisone <10 mg daily or inhaled corticosteroids are allowed.
Long term or concurrent use of corticosteroid therapy other than for premedication or supportive care use as detailed in the protocol; physiologic doses of steroids (e.g. equivalent to or less than oral prednisone 10 mg daily) are allowed and do not require approval
Patients who are on high dose steroid (e.g. > 10 mg prednisone daily or equivalent) or other more potent immune suppression medications (e.g. infliximab)
Patients with treated supratentorial metastases are allowed if stable, the patient is off steroids or on a stable or decreasing dose of =< 10 mg daily prednisone (or equivalent) and no evidence of intracranial hemorrhage
Receiving corticosteroids at > 20 mg (age > 17) or > 0.5 mg/kg (age < 18) daily prednisone dose or equivalent.
At least 2 weeks beyond high dose systemic corticosteroids (however, low dose corticosteroids < 20 mg prednisone or equivalent daily are permitted).
Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of REGN2810
Patients requiring chronic systemic immunosuppressants, including steroids (prednisone daily equivalent of >10 mg).
Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of BI 754091
Ongoing glucocorticoids (prednisone > 10 mg daily, or equivalent); higher doses (> 10 mg daily) are permitted for up to 5 days to help control disease related symptoms
Patients receiving systemic corticosteroids (either intravenous [IV] or oral steroids, excluding inhalers or low-dose hormone replacement therapy as defined no greater than 20 mg of prednisone daily) within 1 week before administration of the first dose of study drug
Any chronic medical condition requiring a higher dose of corticosteroid than 10mg prednisone/prednisolone daily; use of inhaled, intranasal, intra-articular and topical steroids is acceptable, as is a short course (i.e. =< 1 day) of corticosteroids to prevent a reaction to the IV contrast used for CT scans
Had treatment with a short course of corticosteroids (> 10mg daily prednisone equivalents) for symptom relief within 1-week prior to screening.
Patients who have received prior immunotherapy whose side effects have resulted in a requirement of immunosuppressive medications (> 10 mg of prednisone daily or equivalent daily steroid daily, or infliximab, cyclosporine or equivalent immunosuppressive medication) or who have other autoimmune conditions that require immunosuppressive medications as above at the time of screening are excluded
No prior treatment except a prior limited-field radiotherapy, a short course of glucocorticoids =< 25 mg daily of prednisone equivalent which must cease prior to day 1 of cycle 1, and/or cyclophosphamide for an urgent lymphoma related problem at diagnosis (e.g. epidural cord compression, superior vena cava syndrome)
Patients who require emergent use of systemic steroids, chronic use of prednisone (greater than 10mg or an equivalent steroid dose daily) or emergent surgery and/or radiotherapy.
Chronic daily treatment with corticosteroids with a dose of greater than or equal to 10 mg/day methylprednisolone equivalent (excluding inhaled steroids).
Patients who are on high dose steroid (e.g. > 10 mg prednisone daily or equivalent) or other more potent immune suppression medications (e.g. infliximab)
The subject can be on one or more of the following: prednisone (or equivalent corticosteroid) dose =< 20 mg, daily mycophenolate mofetil dose =< 2000 mg/d and cyclosporine/tacrolimus at =< therapeutic blood trough levels; the doses listed are the highest allowed for eligibility
Myelofibrosis subjects must have been treated with ruxolitinib for ? 6 months with a stable dose for ? 8 weeks (acceptable doses are 5 mg twice daily [BID] to 25 mg BID).
No chronic systemic corticosteroids (defined as the equivalent of prednisone >= 20 mg orally [PO] daily for > 6 months during the past year)
Immunosuppressive or systemic hormonal therapy (> 10 mg daily prednisone equivalent) within 2 weeks prior to first administration of IMP and during study; allowed therapies are specified in the protocol.
Medical condition requiring any form of chronic systemic immunosuppressive therapy (steroid or other) except physiologic replacement doses of hydrocortisone or equivalent (no more than 30 mg hydrocortisone or 10 mg prednisone equivalent daily) for < 30 days duration.
Patients requiring corticosteroids use at doses greater than prednisone 10 mg daily equivalent (use of inhaled steroids, and short-term steroid for radiologic contrast allergy, or treatment of immune-related adverse events are allowed)
Systemic (oral/intravenous [IV]/intramuscular [IM]) corticosteroids; patients on chronic stable dose of steroids at an equivalent dose of prednisone ? 10 mg daily may be permitted to enroll at the discretion of principal investigator
Receiving immunosuppressive agents or > 10 mg daily prednisone or equivalent of corticosteroids
Prior treatment with small molecule BET family inhibitor or receiving steroids >the equivalent of 10mg prednisone daily
Chronic corticosteroid use in excess of the equivalent of prednisone 10 mg once daily
Daily requirement for corticosteroids (> 10 mg prednisone daily or equivalent) (except for inhalation corticosteroids) within 2 weeks prior to Cycle 1, Day 1
Systemic continuous corticosteroid therapy at a daily dose higher than 15 mg prednisone or equivalent is not allowed; patients may be using topical or inhaled corticosteroids
Need for daily corticosteroids at high doses (prednisone >= 20 mg daily, or an equivalent) is prohibited from 28 days prior to first dose and during treatment with ibrutinib; brief (up to 7 days) and episodic use of systemic corticosteroids for other general conditions (e.g. pre-medication for radiographic imaging due to intravenous [IV] contrast allergy, chronic obstructive pulmonary disease [COPD] exacerbation, poison ivy, etc.) is allowed
Chronic corticosteroid use in excess of the equivalent of prednisone 10 mg once daily
At least 2 weeks from prior therapy to time of start of treatment; prior therapy includes steroids (except for =< 10 mg daily prednisone or equivalent which is permitted during the study)
Chronic daily treatment with corticosteroids with a dose of >= 10 mg/day methylprednisolone equivalent (excluding inhaled steroids)
Concurrent steroids allowed (up to equivalent of prednisone 20 mg daily, on taper or stable dose for at least 2 weeks)
Systemic corticosteroids at doses greater than 40mg hydrocortisone daily or equivalent for any reason other than treatment of prostate cancer (PCa) within the previous 6 months
Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of REGN2810
Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of the trial treatment (with the exception of subjects with adrenal insufficiency, who may continue corticosteroids at physiologic replacement dose, equivalent to <= 10 mg prednisone daily).
Daily requirement for corticosteroids ? prednisone 10 mg/day or equivalent.
Chronic daily treatment with corticosteroids with a dose of greater than or equal to 10 mg/day methylprednisolone equivalent (excluding inhaled steroids), or any other immunosuppressive drugs.
No corticosteroids, or on a stable or decreasing dose of ? 10 mg daily prednisone (or equivalent)
Patients requiring daily corticosteroids at a prednisone equivalent of >= 20 mg daily should not be enrolled; if corticosteroids can be discontinued (or reduced to < 20 mg per day of prednisone or equivalent), the discontinuation or dose reduction should be done at least 7 days prior to first dose
At least 4 weeks from last dose of therapeutic glucocorticosteroids. Adrenal replacement doses of glucocorticosteroids (up to the equivalent of 10 mg daily prednisone) are allowed.
Concomitant medications that include corticosteroids, chemotherapy, or other therapy that is or may be active against AITL, within the two weeks prior to treatment start. Concurrent corticosteroids are allowed, provided they are administered at an equivalent prednisone dose of ? 10 mg daily, as premedication for blood products only.
Current or recent (within 10 days prior to the first study drug dose) chronic daily treatment with aspirin (> 325 mg/day)
Chronic daily treatment with oral corticosteroids (dose of > 10 mg/day prednisone equivalent) or other immunosuppressive medications within 14 days of randomization
Systemic steroids are allowed as long as they are tapered to the equivalent of 20 milligrams (mg) prednisone daily or less by the start of cycle 2
For phase I, prior intolerance to imatinib at a dose of 400 mg daily
Participants receiving daily treatment with aspirin >325mg/day or other known inhibitors of platelet function.
Patients must not require more than 20 mg prednisone or equivalent corticosteroid daily
Treatment with oral or parenteral corticosteroids dosed greater than 40 mg hydrocortisone daily or its equivalent (e.g., prednisone 10 mg, prednisolone 8 mg, or decadron 3 mg) =< 2 weeks of treatment initiation; or a clinical requirement for ongoing systemic immunosuppressive therapy
Subjects requiring daily corticosteroids at a prednisone equivalent of > 20 mg daily should not be enrolled; if corticosteroids can be discontinued (or reduced to < 20 mg per day or prednisone equivalent), the discontinuation or dose reduction should be done at least 7 days prior to the first dose
Current chronic daily treatment with corticosteroids (dose >10 mg methylprednisolone or equivalent [excluding inhaled steroids])
Use of a systemic steroid (> 5 mg prednisone daily or equivalent) =< 4 weeks prior to registration
Physiologic doses of corticosteroids are allowed (i.e. no more than 10 mg prednisone daily)
PHASE I: Chronic corticosteroid use in excess of the equivalent of prednisone 10 mg once daily
PHASE II: Chronic corticosteroid use in excess of the equivalent of prednisone 10 mg once daily
Current chronic daily treatment (continuous for > 3 months) with corticosteroids (dose equivalent to or greater than 10 mg/day methylprednisolone), excluding inhaled steroids
Chronic daily treatment with corticosteroids with a dose of greater than or equal to 10 mg/day methylprednisolone equivalent (excluding inhaled steroids).
Short-course corticosteroids are permissible in the following circumstances:\r\n* Short course systemic corticosteroids for disease control, improvement of performance status or non-cancer indication (< 10 days) must have been discontinued prior to study treatment\r\n* Ongoing administration of a stable dose of corticosteroid therapy (equivalent to < 30 mg prednisone daily and previously received for >= 30 days) is permissible provided there is evidence of measurable disease and there will be no increase in steroid dose during the clinical trial
Patients requiring daily corticosteroids at a prednisone equivalent of >= 20 mg daily should not be enrolled; if corticosteroids can be discontinued (or reduced to < 20 mg per day of prednisone or equivalent), the discontinuation or dose reduction should be done at least 7 days prior to first dose
Patients requiring daily corticosteroids at a prednisone equivalent of > 20 mg daily should not be enrolled; if corticosteroids can be discontinued (or reduced to < 20 mg per day of prednisone or equivalent), the discontinuation or dose reduction should be done at least 7 days prior to first dose
Requirement for steroid use greater than 10 mg of prednisone daily
Treatment including chemotherapy, chemoimmunotherapy, monoclonal antibody therapy, radiotherapy, high-dose corticosteroid therapy (prednisone >= 60 mg daily, or equivalent), or immunotherapy within 3 weeks prior to enrollment or concurrent with this trial
No current corticosteroid therapy in doses greater than 10 mg daily of prednisone (or equivalent) if given for management of co-morbid conditions.
Is taking chronic systemic steroids (in doses exceeding 10 mg daily of prednisone equivalent) within 7 days prior to the first dose of study treatment
High dose steroids greater to or equal to 60 mg prednisone/day (or equivalent) within 3 months of randomization. No more than 10 mg prednisone (or equivalent) daily at the time of randomization
Subjects who will be or are currently being treated with high dose estrogen (high dose is defined as >0.625mg daily as conjugated estrogens or equivalent) within 7 days prior to study enrollment
Discontinuation of any glucocorticoids prescribed to specifically treat prostate cancer (e.g., as a secondary hormonal manipulation) > 4 weeks prior to receiving first dose of study drug. Glucocorticoids prescribed for a chronic non-cancer-related illness (e.g., asthma or COPD) that is well controlled with medical management are permissible to an equivalent of ? 10 mg prednisone daily.
Systemic treatment with high dose corticosteroids (greater than Prednisone 10mg daily or equivalent).
Minimal immunosuppression (defined as monotherapy with =< 10 mg prednisone daily, =< 200 mg cyclosporine daily, or =< 2 mg tacrolimus daily) at least 2 weeks prior to scheduled treatment
Active treatment with an oral or IV glucocortocoid for ?4 weeks at a daily dose equivalent to or greater than 7.5 mg of oral prednisone
Corticosteroid doses greater than equivalent of prednisone 7.5 mg orally (PO) daily
Receiving chronic systemic corticosteroid therapy > 20 mg of prednisone daily.
Active treatment with an oral or IV glucocortocoid for ?4 weeks at a daily dose equivalent to or greater than 7.5 mg of oral prednisone
Individuals on a stable ruxolitinib dose of 5 mg once daily
Receiving chronic systemic corticosteroid therapy > 20 mg of prednisone daily
Chronic daily treatment with corticosteroids (dose > 10 mg/day methylprednisolone equivalent) excluding inhaled steroids
Active treatment with an oral or IV glucocortocoid for ?4 weeks at a daily dose equivalent to or greater than 7.5 mg of oral prednisone
Active treatment with an oral or IV glucocortocoid for ?4 weeks at a daily dose equivalent to or greater than 7.5 mg of oral prednisone
Receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent ? 5 mg prednisone or equivalent daily.
Most recent enzalutamide dose received is 160 mg once daily with no change in dose for at least 2 weeks prior to Screening.
Chronic corticosteroid use equivalent to >= prednisone 10 mg daily
Daily steroids of > 0.5 mg/kg prednisone or glucocorticoid equivalent, methotrexate, or extracorporeal photopheresis
Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of REGN2810
Current chronic daily treatment with corticosteroids (>/= 10 mg/day methylprednisolone or equivalent), excluding inhaled steroids
Ongoing corticosteroid use with > 10 mg of daily prednisone or equivalent
Receiving chronic daily treatment with aspirin (> 325 mg/day) or other known inhibitors of platelet function
Use of corticosteroids as defined by a daily dose of prednisone (or equivalent) of 5 mg or greater for more than 1 month continuously within 3 months of screening
Treatment with high-dose corticosteroids for anticancer purposes within 14 days before the first dose of TAK-659; daily dose equivalent to 10 mg oral prednisone or less is permitted. Corticosteroids for topical use or in nasal spray or inhalers are allowed.
Pre-existing condition that warrants long-term corticosteroid use greater than the equivalent of 10 mg prednisone daily; physiologic replacement is permitted; topical, intra-articular steroids or inhaled corticosteroids are permitted
Pre-existing opioid daily use of > 60mg morphine sulfate equivalent for reasons not related to LAHNC.
High dose steroid therapy (defined as > 5 mg prednisone, or equivalent, daily)
Chronic opioid use as defined by use of more than 20 mg oxycodone, or equivalent, daily
Known history of chronic pain disorders and/or chronic opioid use defined as > 10 mg of oral (PO) morphine or equivalent used daily for at least 30 days prior to enrollment
On strong opioids with morphine equivalent daily dose of 80-500 mg for at least one week, with stable (i.e. +/- 30%) regular dose over the last 24 hours
Chronic daily opioid requirement
On strong opioid intravenous continuous infusion morphine equivalent daily dose (MEDD) >= 70 mg/day at the time of enrollment
Is receiving high dose corticosteroids (>10 mg prednisone daily or equivalent);
On strong opioids with morphine equivalent daily dose of 60-130 mg for at least one week, with stable (i.e. +/- 30%) regular dose over the last 24 hours
On strong opioids with morphine equivalent daily dose of 80-500 mg, with stable (i.e. +/- 30%) regular dose over the last 24 hours
Patients with a history of severe chronic pain on high dose narcotics (> 25 mg of oxycodone or equivalent daily) preceding diagnosis of cancer
Current daily use of aspirin (> 81 mg daily), Clopidogrel (Plavix), cilostazol (Pletal), aspirin-dipyridamole (Aggrenox) (within 10 days) or considered to use regular use of higher doses of non-steroidal anti-inflammatory agents as determined by the treating physician (e.g. ibuprofen > 800 mg daily or equivalent)
Daily use of Facebook
Treatment with high-dose corticosteroids for anticancer purposes within 14 days before the first dose of TAK-659; daily dose equivalent to 10 mg oral prednisone or less is permitted. Corticosteroids for topical use or in nasal spray or inhalers are allowed.
Any corticosteroid therapy for indications other than GVHD at doses > 1 mg/kg per day methylprednisolone (or prednisone equivalent) within 7 days of randomization.
Chronic use, as defined by > 2 weeks of a corticosteroid agent that is >= 20 mg/day of prednisone or its equivalent, within 4 weeks prior to first administration of BI
Participants who received greater than 10 days of corticosteroids in the preceding 30 days prior to enrollment; physiologic dosing of steroid is 4-5 mg/m^2/day prednisone, 0.03-0.15 mg/kg/day dexamethasone, or 0.5-0.75 mg/kg/day hydrocortisone; contact the AMC Protocol Team for physiologic dosing limits for other corticosteroids
Subjects requiring systemic steroid therapy should be receiving ? 10 mg/day of prednisone (or equivalent) for the 2 weeks preceding start of study.
Subject with Graft vs. Host Disease (GVHD) who is receiving treatment with systemic glucocorticoids > 10 mg/day equivalent of prednisone; however, treatment with low dose glucocorticoids (? 10 mg/day equivalent of prednisone) is permitted
Participants must have steroid refractory cGVHD, defined as having persistent signs and symptoms of chronic GVHD despite the use of prednisone at >= 0. 5 mg/kg/day (or equivalent) for at least 4 weeks; patients may remain on steroids while enrolled in the study
FOR THE PHASE II PORTION OF THE STUDY: Steroid-refractory cGVHD is defined as having persistent signs and symptoms of cGVHD despite the use of prednisone at >= 0.25 mg/kg/day (or 0.5 mg/kg every other day) for at least 4 weeks (or equivalent dosing of alternate corticosteroids) without complete resolution of signs and symptoms; patients with either extensive chronic GVHD or limited chronic GVHD requiring systemic therapy are eligible
Ongoing prednisone requirement > 1 mg/kg/day (or equivalent)
Use of systemic corticosteroids >0.5 mg/kg/day within 10 days prior to obtaining 200 mL whole blood starting material.
A lack of response or disease progression after administration of minimum prednisone 1 mg/kg/day for at least 1 week, OR
Disease persistence without improvement despite continued treatment with prednisone at > 0.5 mg/kg/day or 1 mg/kg/every other day for at least 4 weeks, OR
Increase to prednisolone dose to > 0.25 mg/kg/day after 2 unsuccessful attempts to taper the dose
Any corticosteroid therapy for indications other than cGvHD at doses > 1 mg/kg/day methylprednisolone or equivalent within 7 days of Cycle 1 Day 1
EXCLUSION - INFUSION: Current use of systemic corticosteroids > 0.5 mg/kg/day
Systemic glucocorticoid therapy (prednisone >10 mg/day orally or equivalent) within the last 4 weeks prior to first dose, unless tapered and on a stable dose (prednisone ?10 mg/day orally or equivalent) for at least 1 week.
Patient must be asymptomatic at time of getting SRS (day 0) on trial; prednisone < 10mg/day for at least 7 days prior to treatment is allowed
Corticosteroid doses > 10 mg/day of prednisone or equivalent within 14 days prior to cycle 1 day 1
Use of systemic corticosteroids > 0.5 mg/kg/day prednisolone or equivalent does of alternative corticosteroid within 10 days prior to obtaining 200 mL starting material
Doses ? 10 mg/kg/day prednisolone or equivalent is allowed, provided that the steroid dose has been stable or tapering for at least 14 days prior to the first dose of CUDC-907.
The patient is receiving immunosuppressive therapy for prophylaxis following a prior organ transplant (solid organ or allogeneic stem cell) or management of immune-mediated toxicities due to immunotherapy. Low-dose corticosteroid (defined as < 10mg/day of prednisone or equivalent) therapy is permitted.
Currently taking corticosteroids (> 0.5 mg/kg/day prednisone or equivalent)
Currently taking corticosteroids (> 0.5 mg/kg/day prednisone or equivalent)
Subjects who received any corticosteroid therapy (for non-GVHD) at doses >0.5 mg/kg/day prednisone (or equivalent) within 7 days prior to the onset of GVHD therapy.
Patients may not be receiving systemic corticosteroid therapy at a prednisone dose > 20 mg/day (or steroid equivalent) within 2 weeks of starting study.
Must have one of the following diagnoses:\r\n* Acute GVHD (grade II-IV) requiring systemic therapy and refractory/unresponsive to glucocorticoid (>= 1 mg prednisone-equivalent/kg x 1 week)\r\n* Chronic GVHD that is extensive and not improved despite therapy with glucocorticoid (>= 0.5 mg prednisone-equivalent/kg/day) and therapeutic doses of a calcineurin inhibitor for at least 4 weeks, or worsened within 2 weeks, or overlap syndrome not responding to glucocorticoid treatment (>= 1 mg prednisone-equivalent/kg x 1 week)
Corticosteroid therapy at the time the patient enters the protocol; NOTE: patients using prednisone or its equivalent for adrenal failure or using =< 10mg of prednisone/day for other benign causes are accepted
Current use of systemic corticosteroids > 0.5 mg/kg/day
Currently taking corticosteroids (> 0.5 mg/kg/day prednisone or equivalent) for therapy of GVHD
TREATMENT WITH SJCAR19: Receiving systemic steroids therapy exceeding the equivalent of 0.5 mg/kg/day of methylprednisolone, in the 7 days prior to CAR T-cell infusion
History of any condition requiring anti-platelet therapy (aspirin > 300 mg/day, clopidogrel > 75 mg/day)
Chronic steroid therapy, however prednisone or its equivalent is allowed at =< 10 mg/day.
Inability to begin a prednisone dose ?0.5 mg/kg/d for the treatment of cGVHD
The following medications are prohibited within 2 weeks of enrollment and while on study drug:\r\n* 5 alpha-reductase inhibitors (finasteride, dutasteride)\r\n* Biologic or other agents with anti-tumor activity against prostate cancer (excluding herbal supplements)\r\n* Systemic glucocorticoids greater than the equivalent of 10 mg per day of prednisone\r\n** Premedication with systemic glucocorticoids greater than the equivalent of 10 mg per day of prednisone is permitted prior to docetaxel infusions\r\n* Androgens (testosterone, dehydroepiandrosterone [DHEA], etc.)
Patients on corticosteroids > 0.1 mg/Kg/day (i.e. > the maximum dose of 4mg/day)
Subjects who are currently using more than 5mg/day of prednisone (or an equivalent glucocorticoid exceeding physiologic replacement levels)
The patient must not be on a corticosteroid dose greater than physiologic replacement dosing defined as 30 mg of cortisone per day or its equivalent
Chronic steroid dependency (prednisone equivalent > 10 mg/day); any steroid use should be discontinued at least 2 weeks prior to initiation of study treatment
Has undergone RIC allo BMT: cyclophosphamide (14.5 mg/kg/day) days ?6 and ?5, fludarabine (30 mg/m/day) days ?6 through ?2, total body irradiation (200 cGy) day ?1, day 0 infusion of an unmanipulated bone marrow graft (target 4.0 x 10^8 nucleated cells/kg recipient ideal body\r\nweight), cyclophosphamide (50 mg/kg) days +3 and +4, mycophenolate mofetil days +5 through +35, tacrolimus or sirolimus days +5 through days +180 based on protocol, and filgrastim (5 mcg/kg/day) day +5 through neutrophil recovery (> 1000/uLiter) following Hopkins BMT policy\r\nmanual guidelines
Corticosteroid use >30 mg/day of prednisone or equivalent, for purposes other than lymphoma symptom control
Corticosteroid therapy (>10 mg prednisone/day or equivalent) within 1 week prior to the first dose of study drug
Participants must have steroid-refractory cGVHD, which is defined as having persistent signs and symptoms of cGVHD despite the use of prednisone at 0.20 mg/kg/day (or 0.5 mg/kg every other day) for at least 4 weeks (or equivalent dosing of alternate corticosteroids) without complete resolution of signs and symptoms
Confirmed diagnosis of steroid refractory aGvHD defined as patients administered high-dose systemic corticosteroids (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]), given alone or combined with calcineurin inhibitors (CNI) and either:
Requirement for an increase in the corticosteroid dose to methylprednisolone ?2 mg/kg/day (or equivalent prednisone dose ?2.5 mg/kg/day) , OR
Failure to taper the methylprednisolone dose to <0.5 mg/kg/day (or equivalent prednisone dose <0.6 mg/kg/day) for a minimum 7 days.
Clinically significant and ongoing immune suppression including, but not limited to: systemic immunosuppressive agents such as cyclosporine or corticosteroids (at an equivalent dose of 0.5 mg prednisone/kg per day, or higher), chronic lymphocytic leukemia (CLL), uncontrolled human immunodeficiency virus (HIV) infection
Concurrent systemic steroid therapy higher than physiologic dose (> 7.5 mg/day of prednisone or equivalent)
Patients who are on high dose steroid (equivalent of prednisone more than 10 mg a day) or immune suppression medications
Patients must be on single immune suppression therapy with either tacrolimus or cyclosporine at the time of CD8+ memory T-cell infusion; prednisone at a physiologic dose of 5 mg per day or less is allowed
If on corticosteroids, a dose of < 1 mg/kg prednisone per day or equivalent that has been stable for ? 21 days prior to the first dose of PRTX-100. High-dose pulse steroid therapy is NOT allowed within 14 days prior to the first dose of PRTX-100.
Patients must be clinically stable and off or on low-dose (no more than 0.1 mg/kg/day, max 4 mg/day dexamethasone) corticosteroid for at least one week prior to study registration
Failure to respond to corticosteroids, defined as:\r\n* Progression of chronic GVHD despite optimal first line therapy (> 0.5 mg/kg/day of prednisone dose equivalent [PDE] for two weeks) or\r\n* No improvement after 4-8 weeks of sustained therapy; sustained therapy should include 2 weeks of > 0.5 mg/kg/day of PDE or\r\n* Inability to taper steroid dosage to less than 0.5 mg/kg/day of PDE without worsening of chronic GVHD or \r\n* Need for second or third line therapy beyond corticosteroids and calcineurin inhibitors or sirolimus, irrespective of other criteria
Patients requiring high doses of glucocorticosteroids (? 0.3 mg/kg prednisone or its equivalent)
Patient is on chronic systemic steroid therapy (> 10 mg/kg prednisone or equivalent) within two weeks before the planned date for first dose randomized treatment or on any other form of immunosuppressive medication (premedication with corticosteroid for nausea is permitted)
Chronic usage of aspirin greater than 81 mg/day
Primary immunodeficiency and need for chronic steroid therapy, however prednisone is allowed at < 10 mg/day (Turnstile I)
Patients must be clinically stable and off or on low-dose (no more than 0.1 mg/kg/day, max 4 mg/day dexamethasone) corticosteroid for at least one week prior to study registration
Use of immunosuppressives within four weeks prior to study entry or anticipated use of immunosuppressive agents; patients must be on no more than 0.1 mg/kg/day, max 4 mg/day dexamethasone for at least one week before study registration; topical corticosteroids are acceptable
Current use of systemic corticosteroids > 0.5 mg/kg/day
Patients must be clinically stable and off or on low-dose (no more than 0.1 mg/kg/day, max 4 mg/day dexamethasone) corticosteroid for at least one week prior to study registration
Underwent Autologous SCT 60-120 days prior to registration including:\r\n* BEAM conditioning (BCNU: 300 mg/m2 IV day -7, Etoposide: 100 mg/m2 IV BID days -6,-5,-4,-3, Cytarabine: 100 mg/m2 IV BID days -6,-5,-4,-3, Melphalan: 140 mg/m2 IV day -2)\r\n* Minimum of 2 x 10^6 CD34+ cells/kg infused
Patients must have clinical aGvHD and pathologic findings consistent with the diagnosis by biopsy of at least 1 involved site and treated initially with steroids at prednisone-equivalent doses ?1 mg/kg/day, and i) worsening of GvHD manifestations across any interval of at least 2 days before tapering of steroid doses has begun, or ii) persistence of grade II to IV aGvHD across any interval of at least 7 days without improvement during steroid treatment at any prednisone-equivalent dose >0.4 mg/kg/day or at any lower dose in patients with contraindication to continued treatment at higher steroid doses because of severe steroid-related toxicity (e.g., myopathy), or iii) initial response of GvHD manifestations followed by exacerbation of aGvHD across any interval of at least 3 days while tapering glucocorticoid treatment at any prednisone-equivalent dose >0.4 mg/kg/day or at any lower dose in patients with contraindication to continued treatment at higher steroid doses because of severe steroid-related toxicity (e.g., myopathy).
Ability to be off prednisone and other immunosuppressive drugs (< 1 mg/day) for at least 3 days prior to and while receiving ALT-803
Chronic or long-term corticosteroids: ?0.5 mg/kg/day of oral prednisolone or equivalent
Sporadic corticosteroids: ?1 mg/kg/day of oral prednisolone or equivalent for 2 or more short courses of > 3 days
Prednisone dose ? 20 mg/day
Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of randomization
Chronic systemic steroid therapy defined as prednisone or equivalent 10 mg/day or greater;
REGISTRATION TO TREATMENT (STEP 1): The patient has to be on first-line TKI therapy (the same TKI) for at least 2 years prior to registration\r\n* Dasatinib: 50 – 180 mg per day\r\n* Imatinib: 200 – 800 mg per day\r\n* Nilotinib: 300 – 400 mg every 12-24 hours
Steroid therapy, or steroid therapy with more than 7 consecutive days of steroids within the prior 4 weeks \r\n* The use of prednisone or equivalent < 0.125 mg/kg/day (absolute maximum of 10 mg/day) as replacement therapy is permitted\r\n* Inhaled or topical corticosteroids are permitted
Active immunosuppressive therapy, including concurrent systemic immunosuppressive therapy or steroid therapy with more than 7 consecutive days of steroids within the prior 4 weeks\r\n* The use of prednisone or equivalent < 0.125 mg/kg/day (absolute maximum of 10 mg/day) as replacement therapy is permitted\r\n* Inhaled corticosteroids are permitted
Patients must have clinical evidence* of steroid-refractory acute graft vs host disease (any organ) defined as one of the following:\r\n* Progressive GVHD after at least 3 days on corticosteroids (>= 1 mg/kg of prednisone or equivalent); this means new organ involvement (skin, liver, or intestine) or increased organ specific symptoms sufficient to increase the organ stage by one or more\r\n* No improvement in GVHD after at least 7 days on corticosteroids (>= 1 mg/kg of prednisone or equivalent)\r\n* Patients with protracted acute GvHD who are unable to be tapered below 0.5mg/kg/d of prednisone (without the addition of alternate immunosuppressives) are considered eligible
Patients receiving a stable dose (> 4 weeks) of corticosteroid therapy equivalent to 20 mg of prednisone per day or less are eligible
Patients must have completed prednisone taper (5 mg - 2.5 mg) prior to randomization
Subjects with progressive GVHD (ie, increase in stage in any organ system or any new organ involvement) after 3 days of primary treatment with methylprednisolone ? 2 mg/kg per day (or equivalent).
Subjects with GVHD that has not improved (ie, decrease in stage in at least 1 involved organ system) after 7 days of primary treatment with methylprednisolone ? 2 mg/kg per day (or equivalent).
Subjects who previously began corticosteroid therapy at a lower dose (at least 1 mg/kg per day methylprednisolone) but develop new GVHD in another organ system.
Any corticosteroid therapy for indications other than GVHD at doses of methylprednisolone or equivalent > 1 mg/kg per day within 7 days of enrollment.
Systemic steroid therapy or steroid therapy that cannot be discontinued with more than 7 consecutive days of steroids within the prior 2 weeks\r\n* Note: the use of prednisone or equivalent < 0.125 mg/kg/day (absolute maximum of 15 mg/day) as replacement therapy is permitted; inhaled or topical corticosteroids are permitted
Subject received treatment with systemic glucocorticoids greater than the equivalent of 10 mg per day of prednisone within 4 weeks prior to day 1, intended for the treatment of prostate cancer.
Glucocorticoid therapy (prednisone > 30 mg/day or equivalent) within 7 days prior to study day
Previously untreated and not receiving any other agent that would be considered as a treatment for the lymphoma; for subjects with severe systemic symptoms, compressive disease, or rapidly progressing symptomatic adenopathy, are allowed for lymphoma associated symptom treatment with up to 1 mg/kg/day prednisone, or equivalent, for a maximum of 7 days is permitted prior to beginning the treatment, at the discretion of the investigator; a washout period does not apply
Chronic use of systemic corticosteroid above an accepted physiologic dose (5mg per day of prednisone or equivalent) within 7 days of enrollment except when used as premedication
Steroid use equivalent to greater than 20 mg of prednisone within 4 weeks (28 days) prior to Day 1.
No prior anti-lymphoma therapy. However, for subjects with bulky disease,systemic symptoms, compressive disease, or rapidly progressing adenopathies, pre-phase treatment with 1 mg/kg/day prednisone, or equivalent, for a maximum of 7 days is permitted prior to Cycle 1 Day -6 at the discretion of the Investigator. In exceptional cases, if clinically indicated, a higher dose of steroids and/or a slightly longer duration is allowed for the purpose of urgent symptom management, and the subjects is considered eligible. A washout period does not apply. However the fresh core biopsy mentioned above should be performed before starting prednisone.
DONOR: Any contraindication to the administration of subcutaneous G-CSF at a dose of 16 mg/kg/day for 5 consecutive days
Any corticosteroid therapy (for indications other than GVHD) at doses > 1 mg/kg per day methylprednisolone or equivalent within 7 days of randomization.
No corticosteroid use will be permitted within two weeks prior to study, except for maintenance therapy for a non-malignant disease; maintenance therapy dose may not exceed 20 mg/day prednisone or equivalent
The patient must not be on a corticosteroid dose greater than physiologic replacement dosing defined as 30 mg of cortisone per day or its equivalent
Participants with ongoing corticosteroid use >30 mg per day of prednisone or equivalent
Use of prednisone (or equivalent corticosteroid dose) for SM up to 10 mg/day or its equivalent is allowed, but it cannot have been started during screening; patients who are on prednisone up to 10 mg/day for medical problems unrelated to SM are also permitted on study
Concurrent steroid use of more than an equivalent of 20 mg/day prednisone (or equivalent)
Current or recent (=< 10 days prior to randomization) use of aspirin (> 325 mg/day), or clopidogrel (> 75 mg/day)
Patients who are on high dose steroid (i.e. prednisone or equivalent more than 10 mg a day) or immune suppression medications
Patient has a medical condition that requires chronic systemic steroid therapy or requires any other form of immunosuppressive medication; however, patients using physiologic replacement doses of hydrocortisone, or its equivalent, will be considered eligible for this study; up to 20 mg hydrocortisone (or 5 mg of prednisone) in the morning and 10 mg hydrocortisone (or 2.5 mg of prednisone) in the evening
Participants must have steroid-refractory cGVHD; steroid-refractory cGVHD is defined as having persistent signs and symptoms of cGVHD despite the use of prednisone at >= 0.25 mg/kg/day (or 0.5 mg/kg every other day) for at least 4 weeks (or equivalent dosing of alternate corticosteroids) without complete resolution of signs and symptoms; patients with either extensive chronic GVHD or limited chronic GVHD requiring systemic therapy are eligible
Ongoing prednisone requirement > 1 mg/kg/day (or equivalent)
Participants must have steroid-refractory chronic GVHD (cGVHD); steroid-refractory cGVHD is defined as having persistent signs and symptoms of cGVHD despite the use of prednisone at >= 0.25 mg/kg/day (or 0.5 mg/kg every other day) for at least 4 weeks (or equivalent dosing of alternate glucocorticoids) without complete resolution of signs and symptoms; participants with either extensive or limited chronic GVHD requiring systemic therapy are eligible
Participants with ongoing prednisone (equivalent) dose requirement > 1 mg/kg/day (or equivalent)
Corticosteroid therapies of > 20 mg/day prednisone, > 4 mg/day dexamethasone, > 80 mg/day hydrocortisone, or equivalent; oral, inhaled, or topical steroids are allowed during study as long as it does not exceed 80 mg/day hydrocortisone
Patients with medical conditions that require chronic systemic corticosteroid therapy or require any other form of immunosuppressive medication. However, patients using physiologic replacement doses of hydrocortisone, or its equivalent, will be considered eligible for this study: up to 20 mg hydrocortisone (or 5 mg of prednisone) in the morning and 10 mg hydrocortisone (or 2.5 mg prednisone) in the evening.
Steroid refractory cGVHD, defined as having persistent signs and symptoms of cGVHD despite ? 4 weeks of prednisone (or equivalent) dosed at ? 0.25 mg/kg/day (or ? 0.5 mg/kg every other day) within the 12 months prior to screening.
Stable dose of ? 1 mg/kg/day of systemic prednisone or equivalent for at least 2 weeks prior to first dose of AMG 592.
Has cGvHD that did not respond to high-dose corticosteroids (average 0.5 mg/kg/d prednisone for >= 8 weeks) or second-line systemic therapy
Patients can be enrolled and begin study therapy with ofatumumab within 14 days from initiation of 1 mg/kg/day prednisone for therapy of chronic GVHD
Patients with chronic graft versus host disease (GVHD) that involves 3 or more organs or with a score of 2 or greater in any single organ based on National Institutes of Health (NIH) cGVHD grading and have the following relationship with steroid:\r\n* Dependent disease - cGVHD manifestations requiring a glucocorticoid dose >= prednisone 0.25 mg/kg/day (0.5 mg/kg by mouth every other day) for at least 12 weeks\r\n* Refractory disease - Progressive cGVHD manifestations despite treatment with a glucocorticoid dose >= prednisone 0.5 mg/kg/day (1 mg/kg by mouth every other day) for at least 4 weeks\r\n* Steroid intolerant
Current or recent (=< 10 days prior to randomization) use of aspirin (> 325 mg/day), clopidogrel (> 75 mg/day), or prasugrel (> 10 mg/day)
The patient requires treatment with corticosteroids at a dose > 0.1 mg/kg/day or has a known allergy to DSMO
Clinically stable and off or on low dose (no more than 0.1 mg/kg/day, maximum of 4 mg/day dexamethasone) corticosteroid for at least 1 week prior to study enrollment
Corticosteroid doses > 10 mg/day of prednisone or equivalent within 14 days prior to cycle 1 day 1
Steroid dose not greater than 2 mg/kg prednisone equivalent at time of study enrollment; if patient has steroid refractory GVHD (defined as worsening of GVHD after 3 days of 2 mg/kg prednisone equivalent or no improvement after 7 days of 2 mg/kg prednisone equivalent), time interval from start of steroids to initiation of ECP should not be > 14 days
Platelet count > 600 × 10^9/L after 3 months of at least 2 g/day of hydroxyurea (2.5 g/day in subjects with a body weight over 80 kg) OR at the subject's maximally tolerated dose if that dose is < 2 g/day.
Patients requiring concurrent systemic steroid therapy higher than physiologic dosage (>10mg/day of prednisone or equivalent).
Inability to begin prednisone therapy at a dose of greater than 0.5 mg/kg/day.
Already receiving sirolimus (for prophylaxis or treatment of acute GVHD) with prednisone at ? 0.25 mg/kg/day (or equivalent) ± additional agents.
Ongoing corticosteroid use >30 milligrams per day (mg/day) prednisone or equivalent
Patients must have received a trial of corticosteroids equivalent to prednisone greater than or equal to 0.5 mg/kg/d for at least one month; OR at least one pulse of methylprednisolone at a dose at least 1000 mg/d for 3 days on at least one occasion within the previous 6 months prior to the transplant decision
Corticosteroid administration >20 mg/day of prednisone or equivalent within 14 days
Inclusion Criteria:\n\n        Male or female subjects may be entered in the study only if they meet all of the following\n        criteria:\n\n          1. Age ?18 and ?65 years of age.\n\n          2. Recipient of an allogeneic hematopoietic stem cell transplantation.\n\n          3. Steroid-resistant acute GvHD, Grade II-IV, defined as: progressive disease after 3\n             days of primary treatment with methylprednisolone 2 mg/kg, or equivalent; or lack of\n             at least a partial response after 7 days of primary treatment with methylprednisolone\n             2 mg/kg or equivalent; or lack of a complete response after 14 days of primary\n             treatment with methylprednisolone 2 mg/kg or equivalent. Note: Subjects who may have\n             received an increase in their steroid dose treatment prior to randomization will be\n             eligible for enrolment.\n\n          4. Evidence of myeloid engraftment (absolute neutrophil count ?0.5 x 10E9/L).\n\n          5. Karnofsky Performance Status score ?50%.\n\n          6. Adequate renal function as defined by serum creatinine ?2 × ULN or calculated CrCl of\n             ?30 mL/min using the Cockroft-Gault equation: Calculated CrCl= ([140-age in years] x\n             [ideal body mass {IB
Has primary steroid-refractory GvHD. Steroid-refractory disease is defined as worsening or no improvement in 5 to 7 days of treatment with methylprednisolone 2 milligram per kilogram (mg/kg) or equivalent or lack of a CR after 14 days of primary treatment with methylprednisolone 2 mg/kg or equivalent. Note that participants who develop intestinal GvHD while receiving systemic therapy for other GvHD are still eligible after 5 to 7 days, even if the intestinal GvHD has not been present for the entire duration. Participants who may have received an increase in their steroid dose treatment (example, increased methylprednisolone from 1 mg/kg to 2 mg/kg) before enrollment will be eligible, provided the participant has met the definition of steroid refractory above. Participants who develop toxicity on corticosteroids or who are otherwise medically unable to be dosed to this level, will also be eligible.
Patients with steroid refractory graft versus host disease (SRGvHD). SRGvHD is defined as progression (=increase in overall grade) after 5 days on ?2mg/kg methylprednisolone or equivalent OR no improvement (no decrease in overall grade) after 10 days on ? 2mg/kg methylprednisolone or equivalent. If patients are receiving steroids for GvHD prophylaxis as per center standard, progression after 5 days and no response after 10 days after doubling the steroid dose will be regarded as steroid refractory.
Patients must have failed at least two forms of immunosuppression:\r\n* Moderate-to-high dose corticosteroids (0.5-1 mg/kg/day**, and/or IV pulse methylprednisolone)\r\n** When cyclophosphamide is the accepted standard of care (renal and neurologic), the maximally tolerated dose of prednisone will be sufficient to meet the corticosteroid criterion\r\n* Azathioprine, methotrexate, cyclosporine, tacrolimus, belimumab, rituximab, or mycophenolate mofetil, in the case of severe and ongoing hemolytic anemia and/or thrombocytopenia, failure of intravenous immunoglobulin treatment will count as the second treatment
Receiving a new course of systemic corticosteroids (? 0.5 mg/kg/day) as first-line cGVHD therapy at least 1 day and no more than 21 days prior to first dose of ENTO/Placebo AND
Inability to begin systemic corticosteroids therapy at a dose of ? 0.5 mg/kg/day (or equivalent)
Patient has failed to respond to steroid treatment, with failure to respond defined as any Grade B-D (IBMTR grading) acute GVHD that shows progression within 3 days, or no improvement within 7 consecutive days, of treatment with 2 mg/kg/day methylprednisolone or equivalent.
Ongoing corticosteroid use >30 milligrams per day (mg/day) of prednisone or equivalent. Participants receiving corticosteroid treatment with less than equal to (</=) 30 mg/day of prednisone or equivalent must be documented to be on a stable dose of at least 4 weeks duration prior to randomization (Cycle 1 Day 1)
On immunosuppressive or other anti-leukemic therapy, excluding patients receiving glucocorticoids for management of circulating blast count or patients on a stable dose (<20mg/m2/day prednisone or equivalent) of systemic or topical glucocorticoid therapy with ? Grade 1 GvHD or tapering dose of calcineurin inhibitor
Glucocorticoid therapy (prednisone > 30 mg/day or equivalent within 14 days of first dose)
Glucocorticoid therapy (prednisone > 30 mg/day or equivalent) within 14 days prior to randomization
Glucocorticoid therapy (prednisone > 10 mg/day or equivalent) within the last three weeks
Contraindication to any of the required concomitant drugs, including antiviral (e.g. Valacyclovir) and proton-pump inhibitor (e.g. lansoprazole). Corticosteroid therapy in a dose equivalent to dexamethasone ? 1.5 mg/day or prednisone ? 10 mg/day. (Steroid use is allowed if necessary to treat spinal cord compression and/or hypocalcaemia.)
Ongoing corticosteroid use >30 mg per day prednisone or equivalent, for purposes other than lymphoma symptom control
Doses ? 10 mg/day prednisolone or equivalent is allowed, provided that the steroid dose has been stable or tapering for at least 14 days prior to the first dose of CA-4948
Glucocorticoid therapy (prednisone > 30 mg/day or equivalent) within 14 days prior to randomization.
Glucocorticoid use, unless given in doses less than or equal to 25mg/Day prednisone (or equivalent) for less than 7 Days for exacerbations other than CLL (e.g. asthma).*
Supraphysiologic doses of glucocorticoids (defined as > 30 mg of hydrocortisone per day or > 7.5 mg of Prednisone per day, or equivalent doses of other agents) or exposure to other immunosuppressive medications in the previous 30 days.
Chronic GVHD that did not respond to high-dose corticosteroids (prednisone at 1.0 mg/kg/day for at least 1 week or prednisone at 0.5 mg/kg/day or 1 mg/kg every other day for at least 4 weeks), or second-line therapy (any)
Steroid-Refractory/Dependent aGVHD (ARM 2)\r\n* Pediatric or adult HCT recipient with grade II-IV steroid refractory or steroid-dependent acute GVHD, defined as any one of the following:\r\n** No response of acute GVHD after at least 4 days of systemic corticosteroids of at least 2 mg/kg prednisone or equivalent\r\n** Progression of acute GVHD within 3 days of systemic corticosteroids of at least 2 mg/kg prednisone or equivalent\r\n** Failure to improve to at least grade II acute GVHD after 14 days of systemic corticosteroids, with initial doses of at least 2 mg/kg prednisone or equivalent\r\n** Flare of acute GVHD of at least grade II/IV severity while on steroids at a dose > 0.1/mg/kg/day; this can include late-onset aGVHD and overlap syndrome
Patients receiving high dose opioids on a chronic basis (greater than or equivalent to 60 mg of morphine per day)
Patients requiring high doses of glucocorticosteroids (>= 0.3 mg/kg prednisone or its equivalent)
Receiving anastrozole (1 mg) or letrozole (2.5 mg) orally once a day, for >= 21 days prior to registration and plan to continue throughout the duration of study
Steroid dependent/refractory cGVHD defined as:\r\n* Steroid dependent disease: Persistent cGVHD manifestations requiring a glucocorticoid dose >= prednisone 0.25 mg/kg/day (0.5 mg/kg orally [po] every other day) for at least 12 weeks\r\n* Steroid refractory disease: Progressive cGVHD manifestations despite treatment with a glucocorticoid dose >= prednisone 0.5 mg/kg/day (1 mg/kg po every other day) for at least 4 weeks
Cancer patients with severe pain (i.e., >= 7 on NRS) already on opioid therapy for one week or longer, at least 60 mg of oral morphine/day, 25 mcg of transdermal fentanyl/hour, 30 mg of oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid
Patients using >= 20 mg/day of prednisone (or steroid equivalent dose) for any chronic medical condition
Patients must have steroid refractory chronic (c) GVHD, defined as having persistent signs and symptoms of chronic GVHD despite the use of prednisone at >= 0.25 mg/kg/day (or 0.5 mg/kg every other day) for at least 2 weeks in the preceding 12 months (or equivalent dosing of alternate corticosteroids) without complete resolution of signs and symptoms, or if not responding to any lines of therapy beyond steroids, or if the MD feels adding/increasing steroids would not be in the patient’s best interest
Ongoing prednisone requirement > 1 mg/kg/day (or equivalent)
Participants must have steroid-refractory chronic graft-versus-host disease (cGVHD); steroid-refractory cGVHD is defined as having persistent signs and symptoms of cGVHD despite the use of prednisone at >= 0.25 mg/kg/day (or 0.5 mg/kg every other day) for at least 4 weeks (or equivalent dosing of alternate glucocorticoids) without complete resolution of signs and symptoms; participants with either extensive chronic GVHD or limited chronic GVHD requiring systemic therapy are eligible
Ongoing prednisone requirement > 1 mg/kg/day (or equivalent)
Acute GVHD must be corticosteroid refractory as defined by:\r\n* Progressive GVHD after at least 3 days on corticosteroids (>= 1 mg/kg of prednisone or equivalent); this means new organ involvement (skin, liver, or intestine) or increased organ specific symptoms sufficient to increase the organ stage by one or more\r\n* No improvement in GVHD after at least 7 days on corticosteroids (>= 1 mg/kg of prednisone or equivalent) OR insufficient improvement which warrants the addition of another systemic agent at the opinion of the treating investigator\r\n* GVHD during taper of corticosteroids which is unable to be tapered below 0.5 mg/kg/day of prednisone equivalent or, in the opinion of the treating physician, requires addition of another systemic agent
Patients must have steroid refractory classic cutaneous, myofascial, or sclerodermatous cGVHD (+/- other organ involvement, clinically diagnosed), defined as having persistent signs and symptoms of chronic GVHD despite the use of prednisone at >= 0.25 mg/kg/day (or 0.5 mg/kg every other day) for at least 4 weeks in the preceding 12 months (or equivalent dosing of alternate corticosteroids) without complete resolution of signs and symptoms or if not improving on any line of therapy beyond steroids or if treating physician feels that increasing or adding steroids is not in the patient’s best interests; note that the dose of systemic steroids can certainly be lower than 0.25 mg/kg/day at enrollment
Ongoing prednisone requirement > 1 mg/kg/day (or equivalent)
Patients who have not shown a satisfactory response to methylprednisolone-equivalent doses at 2 mg/kg/day, based on adjusted body weight
Patients with steroid refractory chronic GVHD are defined as having persistent signs and symptoms of chronic GVHD despite the use of prednisone at >= 0.5 mg/kg/day for at least 2 weeks in the preceding 24 months (or equivalent doses of alternate corticosteroids) without complete resolution of signs and symptoms
Requires immunosuppressive doses of corticosteroid therapy (> 10 mg/day prednisone equivalents) for >= 2 weeks prior to registration
Any prior cumulative doxorubicin dose must be ? 360 mg/m2; prior cumulative epirubicin dose must be ? 720 mg/m2.
History of exposure to certain cumulative doses of anthracyclines
History of exposure to cumulative doxorubicin dose ? 360 mg/meter squared. If another anthracycline or more than one anthracycline has been used, then the cumulative dose must not exceed the equivalent of 360 mg/meter squared of doxorubicin
Greater than 5 weeks from doxorubicin at the time of consent, with radiation to be initiated no less than 6 weeks from doxorubicin
Cumulative dose of doxorubicin or equivalent of > 360 mg/m^2 during prior adjuvant therapy
Received previous systemic chemotherapy with a cumulative dose of > 900 mg/m^2 of epirubicin or > 400 mg/m^2 of doxorubicin
If liposomal doxorubicin hydrochloride (DOXIL) is selected as the investigator’s choice chemotherapy:\r\n* Lifetime exposure to doxorubicin =< 240 mg/m^2 (or equivalent biologic dose if prior exposure to a different anthracycline)
Cumulative anthracycline exposure greater than 450mg/m^2 doxorubicin equivalents prior to enrollment
Cumulative doxorubicin dose >= 400 mg/m^2 (> 450 mg/m^2 for malignant soft tissue and bone tumor patients) or cumulative epirubicin dose >= 800 mg/m^2
Cumulative anthracyclines must not exceed 450 mg/m^2 doxorubicin equivalents following completion of treatment on protocol; therefore for patients receiving one course on protocol cumulative anthracyclines must be less than or equal to 400 mg/m^2 doxorubicin equivalents at the time of enrollment
Prior anthracycline cumulative dose below 550 mg/m2 or the daunorubicin equivalent which is the recommended non-cardiotoxic level.
Patients with a prior cumulative cisplatin dose > 300 mg/m^2 (pertains to Arm A only)
Patients have received a cumulative dose of doxorubicin of greater than 360 mg/m^2 or epirubicin of greater than 640 mg/m^2
Patients who have received a cumulative doxorubicin equivalent of > 375 mg/m^2 total lifetime dose
Prior therapy resulting in cumulative epirubicin dose >= 900 mg/m^2 or cumulative doxorubicin dose >= 500mg/m^2 or equivalent dose of another anthracycline
Patients who have received a cumulative dose of doxorubicin of greater than 360 mg/m^2 or epirubicin of greater than 640 mg/m^2
Planning to initiate treatment with doxorubicin (starting dose of 75 mg/m^2) and olaratumab (starting dose of 15 mg/kg) as routine care
Cumulative lifetime anthracycline dose of =< 450mg/m^2
Prior cumulative dose of doxorubicin of greater than 360 mg/m^2 or epirubicin of greater than 640 mg/m^2
Prior anthracycline therapy does not exceed 200 mg/m^2 total cumulative dose
Previous treatment with complete cumulative doses of daunorubicin, idarubicin, and/or other anthracyclines and anthracenediones that is equivalent to a total dose of > 200 mg/m^2 doxorubicin
If history of exposure to anthracyclines during perioperative treatment, the following cumulative doses of anthracyclines must be less than:\r\n* Epirubicin < 720 mg/m^2\r\n* Doxorubicin or liposomal doxorubicin < 360 mg/m^2\r\n* Mitoxantrone > 120 mg/m^2 and idarubicin > 90 mg/m^2\r\nIf more than one anthracycline has been used, then the cumulative dose must not exceed the equivalent of 360 mg/m^2 of doxorubicin
Prior exposure to >375 mg/m2 of doxorubicin or liposomal doxorubicin.
History of exposure to cumulative doses of doxorubicin greater than 360 mg per square meter of body-surface area or its equivalent
Patients with treatment related myeloid neoplasms with cumulative anthracyclines greater than 230 mg/m^2 doxorubicin equivalents
Patients who have received > 450 mg/m^2 daunorubicin equivalents; patients who relapse after receiving AAML0531/AAML1031 therapy will be eligible for this study, provided they have not received any additional anthracyclines; NOTE: for the purposes of determining eligibility for this protocol, the following cardiotoxicity multipliers will be used to determine daunorubicin equivalents:\r\n* Doxorubicin (doxorubicin hydrochloride): 1\r\n* Mitoxantrone: 3\r\n* Idarubicin: 3\r\n* Epirubicin: 0.5
No more than a total cumulative dose of 450 mg/m^2 of prior doxorubicin chemotherapy
Cumulative lifetime dose of anthracycline chemotherapeutic > 80 mg/m^2
Patients who have received prior doxorubicin may not have had more than 320 mg/m^2 total dose and must have a normal left ventricular ejection fraction (LVEF) (>= 45%); (this includes Doxil or other liposomally encapsulated doxorubicin preparations)
The participant received previous chemotherapy with a cumulative dose of >900 mg per meter squared (mg/m^2) of epirubicin or >400 mg/m^2 of doxorubicin.
Prior treatment with anthracyclines at cumulative doses of 450 mg/m² or more for doxorubicin or 900 mg/m² or more for epirubicin
Prior exposure to cumulative doses of doxorubicin >400 mg/m2 or epirubicin >720 mg/m2
Prior treatment with doxorubicin or other anthracycline at cumulative doses greater than 300 mg/m2 (calculated using doxorubicin equivalent doses: 1 mg doxorubicin = 1 mg Doxil/Caelyx = 1.8 mg epirubicin = 0.3 mg mitoxantrone = 0.25 mg idarubicin)
History of exposure to the cumulative doses of anthracyclines
History of prior cumulative exposure to >= 300 mg/m^2 cisplatin, area under the curve (AUC) of 18 of carboplatin, or their combined equivalent within one year prior to enrollment
Subject has received a cumulative anthracycline dose above 400 mg/m2 of doxorubicin (or cumulative maximum dose of another anthracycline).
History of exposure at any time to the following cumulative doses of anthracyclines:\r\n* Doxorubicin or liposomal doxorubicin > 500 mg/m^2\r\n* Epirubicin > 900 mg/m^2\r\n* Mitoxantrone >120 mg/m^2\r\n* Another anthracycline, or more than one anthracycline used in a cumulative dose exceeding the equivalent of doxorubicin 500 mg/m^2
Prior cumulative exposure to doxorubicin (including liposomal preparation) > 350 mg/m^2
Patients with therapy-related AML or MDS should have not received prior cumulative anthracycline (daunorubicin equivalent) lifetime dose > 450 mg/m^2
Patients who have previously had > 368 mg/m^2 cumulative dose of daunorubicin or > 368 mg/m^2 daunorubicin-equivalent anthracycline therapy (for example, from prior treatment of solid tumors)
Patient had prior exposure to a cumulative dose of doxorubicin that exceeded 360 mg/m2 or its equivalent.
Received prior therapy resulting in a cumulative epirubicin dose > 900 mg/m^2 or cumulative doxorubicin dose > 450 mg/m^2; if another anthracycline or more than one anthracycline has been used, the cumulative dose must not exceed the equivalent of 450 mg/m^2 doxorubicin
Previous treatment with complete cumulative doses of daunorubicin, idarubicin, and/or other anthracyclines and anthracenediones that is equivalent to a total dose of 240 mg/m^2 doxorubicin
Prior exposure to systemic intravenously given doxorubicin
Prior treatment with doxorubicin (doxorubicin hydrochloride) up to 400 mg/m^2
History of exposure to the following cumulative doses of anthracyclines: Doxorubicin > 240 mg/m2; Epirubicin or Liposomal Doxorubicin-Hydrochloride (Myocet®) > 480 mg/m2; For other anthracyclines, exposure equivalent to doxorubicin > 240 mg/m2
Patients with prior cumulative anthracycline exposure of greater than 368 mg/m2 daunorubicin (or equivalent).
Maximum prior cumulative doxorubicin dose of =< 360 mg/m^2 or equivalent
Cumulative anthracycline exposure greater than 200 mg/m^2 doxorubicin isotoxic equivalents
Prior treatment with cumulative dose of doxorubicin or equivalent exceeding 450 mg/m2
History of cumulative doxorubicin or liposomal doxorubicin dose > 430 mg/m^2
Prior treatment with anthracyclines with a cumulative dose of doxorubicin of greater than 400 mg/m2, or of epirubicin dose of greater than 800 mg/m2, or the equivalent dose for other anthracyclines or derivatives (part 2 only).
No more than 3 prior lines of chemotherapy; prior therapy with doxorubicin is permitted but no more than lifetime cumulative dose of 150 mg/m^2; at least 3 weeks since prior chemotherapy or radiotherapy, at least 6 weeks if the last regimen included bis-chloroethylnitrosourea (BCNU) or mitomycin C
Patients who have previously been treated with doxorubicin, liposomal doxorubicin, epirubicin, mitoxantrone, or any other anthracycline derivative
Prior anthracycline therapy with a cumulative dose of doxorubicin (or equivalent) >= 400 mg/m^2
Prior exposure to anthracyclines or anthracenediones including doxorubicin, daunorubicin, and mitoxantrone
Any prior cumulative doxorubicin dose must be ? 360 mg/m2; prior cumulative epirubicin dose must be ? 720 mg/m2.
Prior exposure to greater than 360 mg/m2 doxorubicin or liposomal doxorubicin, greater than 120 mg/m2 mitoxantrone, greater than 90 mg/m2 idarubicin, or greater than 720 mg/m2 epirubicin
History of exposure to the following cumulative doses of anthracyclines:
Doxorubicin or liposomal doxorubicin >350 mg/m².
Epirubicin >530 mg/m².
If another anthracycline or more than 1 anthracycline has been used, then the cumulative dose must not exceed the equivalent of 350 mg/m² of doxorubicin.
Patients with prior cumulative anthracycline exposure of greater than 368 mg/m2 daunorubicin (or equivalent)
Prior exposure to >375 mg/m2 of doxorubicin or liposomal doxorubicin.
Time to treatment failure from doxorubicin containing regimen ? 12 months if previously treated with doxorubicin.
Prior epirubicin exposure of > 600 mg/m2.
Prior therapy with anthracyclines exceeding the following doses (subjects will be discontinued at 600 mg/m2 lifetime dose irrespective of the number of ThermoDox® cycles received): Free (i.e., non-liposomal) or liposomal doxorubicin > 450 mg/m2 Free epirubicin > 900 mg/m2.
Prior cumulative doxorubicin dose > 300 mg/m^2
Patients with prior cumulative anthracycline exposure of greater than 368 mg/m2 daunorubicin (or equivalent)
Prior treatment with anthracyclines at cumulative doses of 450 mg/m² or more for doxorubicin or 900 mg/m² or more for epirubicin
Cohort 2: Soft tissue sarcoma of intermediate or high grade with evidence of disease progression by either CT or MRI scan, or clinical judgment on or after the last cancer therapy within 6 months prior to the start of study treatment. Relapsed or refractory (lack of response) to ?1 course of systemic therapy regimen(s), excluding adjuvant or neoadjuvant chemotherapy, and is incurable by either surgery or radiation. Patients who have previously received anthracyclines are eligible if cumulative exposure is <375 mg/m2 for doxorubicin and liposomal doxorubicin or <675 mg/m2 for EPI.
Prior exposure to >375 mg/m2 of doxorubicin or liposomal doxorubicin or ?675 mg/m2 of EPI.
Chemotherapy must be planned for at least 4 cycles of full-dose anthracycline or taxane based chemotherapy regimen\r\n* Defined as one of the following regimens: \r\n** Adriamycin 60 mg/m2 with cyclophosphamide 600 mg/m2 \r\n** Epirubicin 90-100 mg/m2 with cyclophosphamide 600 mg/m2 \r\n** Doxorubicin 50 mg/m2 with 5-fluroruacil 500 mg/m2 and cyclophosphamide 500 mg/m2 \r\n** Paclitaxel 80 mg-90/m2 weekly (every three weeks constitute a cycle), or 175 mg/m2 every 2-3 weeks as a single agent \r\n** Docetaxel 100 mg/m2 as a single agent \r\n** Docetaxel 75 mg/m2 with cyclophosphamide 600 mg/m2 \r\n** Docetaxel 75 mg/m2 with carboplatin area under the curve (AUC) of 6 and traztuzumab at standard doses\r\n* Concurrent traztuzumab at standard doses is allowed\r\n* Concurrent pertuzumab at standard doses is allowed\r\n* Administration of chemotherapy on a dose dense schedule is allowed as clinically indicated
Lifetime cumulative anthracycline dose: >= 300 mg/m^2 without the protection of dexrazoxane (Zinecard) therapy
If in Arm D (doxorubicin and cyclophosphamide), patients with prior cumulative doxorubicin dose of >= 260 mg/m^2
Scheduled to receive chemotherapy with an anthracycline (doxorubicin [doxorubicin hydrochloride] or epirubicin [epirubicin hydrochloride])
Prior exposure to more than 360 mg/m^2 doxorubicin, more than 120 mg/m^2 mitoxantrone, or more than 90 mg/m^2 idarubicin, or elevated baseline cardiac troponin I
Prior exposure to anthracyclines at a cumulative dose of doxorubicin (or equivalent) > 450 mg/m²
5. Current use or prior use of immunosuppressive medication within 4 weeks prior to first dose of TAB001, with the exception of intranasal and inhaled corticosteroids or systemic corticosteroids not to exceed 10mg/day of prednisone or equivalent;
Current or prior use of immunosuppressive medication within 28 days before the first dose of study therapy with the exceptions of intranasal corticosteroids or systemic corticosteroids at physiological doses that do not exceed 10mg/day of prednisone or an equivalent corticosteroid.
Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
Are currently receiving or have had prior use of immunosuppressive medication within 28 days before the first dose of study drug, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 milligrams/day of prednisone, or an equivalent corticosteroid.
Current or prior use of immunosuppressive medication within 28 days before the first dose of treatment on this protocol, with the exceptions of:\r\n* Intranasal and inhaled corticosteroids\r\n* Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent\r\n* Premedication for hypersensitivity reactions (e.g. to computed tomography [CT] contrast for scans).
Use of intranasal and inhaled corticosteroids or systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent is permitted.
Current or prior use of immunosuppressive medication 7 days before the first dose of nivolumab or ipilimumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid; a brief course (=< 28 days) of corticosteroids for prophylaxis (eg, contrast dye allergy) or for treatment of non-autoimmune conditions (eg, delayed-type hypersensitivity reaction caused by contact allergen) is permitted
Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab or tremelimumab, with the exceptions of: intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid or steroids as pre-medication for hypersensitivity reactions (e.g. CT scan premedication).
Current use or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal, inhaled, and intra-articular corticosteroids or systemic corticosteroids at physiological doses which are not to exceed 10 mg/day of prednisone or an equivalent corticosteroid
Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab or tremelimumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab or tremelimumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab or tremelimumab with the exceptions of premedication and intranasal, topical and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab or tremelimumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab or tremelimumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab OR tremelimumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. Steroid premedication for the prevention of radiologic contrast hypersensitivity is allowed.
Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab (MEDI4736) or tremelimumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab or tremelimumab, with the exceptions of intranasal, topical, and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
Current or prior use of immunosuppressive medication within 28 days before the first dose of nivolumab, with the exceptions of intranasal, topical, and inhaled corticosteroids or systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent (use for brain metastases is not permitted 28 days prior to start of therapy)
Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab or tremelimumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
Current or prior use of immunosuppressive medication within 14 days before the first dose of MEDI4736 and tremelimumab with the exceptions of intranasal and inhaled corticosteroids, systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent, or steroids used transiently to control contrast agent allergies for radiographic studies
Current or prior use of immunosuppressive medication within 28 days before the first dose of MEDI4736, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
Current or prior use of immunosuppressive therapy within 14 days before the first dose of durvalumab or tremelimumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nCurrent or prior use of immunosuppressive medication within 28 days before the first dose of MEDI4736, with the exception of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone or an equivalent corticosteroid; in the case of short term use of systemic corticosteroids (less than 24 hours within 28 days) of greater than 10 mg/day of prednisone or an equivalent corticosteroid, the required washout period prior to starting the first dose of MEDI4736 is 7 days
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nCurrent or prior use of immunosuppressive medication within 28 days before the first dose of MEDI4736, with the exception of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone or an equivalent corticosteroid; in the case of short term use of systemic corticosteroids (less than 24 hours within 28 days) of greater than 10 mg/day of prednisone or an equivalent corticosteroid, the required washout period prior to starting the first dose of MEDI4736 is 7 days
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nCurrent or prior use of immunosuppressive medication within 28 days before the first dose of MEDI4736, with the exception of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone or an equivalent corticosteroid; in the case of short term use of systemic corticosteroids (less than 24 hours within 28 days) of greater than 10 mg/day of prednisone or an equivalent corticosteroid, the required washout period prior to starting the first dose of MEDI4736 is 7 days
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nCurrent or prior use of immunosuppressive medication within 28 days before the first dose of MEDI4736, with the exception of intranasal, inhaled, ophthalmological, or topical corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone or an equivalent corticosteroid; in the case of short term use of systemic corticosteroids (less than 24 hours within 28 days) of greater than 10 mg/day of prednisone or an equivalent corticosteroid, the required washout period prior to starting the first dose of MEDI4736 is 7 days
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nCurrent or prior use of immunosuppressive medication within 28 days before the first dose of MEDI4736, with the exception of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone or an equivalent corticosteroid; in the case of short term use of systemic corticosteroids (less than 24 hours within 28 days) of greater than 10 mg/day of prednisone or an equivalent corticosteroid, the required washout period prior to starting the first dose of MEDI4736 is 7 days
Current or prior use of immunosuppressive medication within 28 days before the first dose of MEDI4736, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
Active or prior history of autoimmune or inflammatory condition requiring ongoing immunosuppressive medications. This specifically includes use of immunosuppressive medication within 28 days before the first dose of durvalumab with the exceptions of intranasal corticosteroids or systemic corticosteroids at physiological doses, which do not exceed 10mg/day of prednisone or an equivalent corticosteroid.
Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab and tremelimumab with the exceptions of intranasal and inhaled corticosteroids, systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent, or steroids used transiently to control contrast agent allergies for radiographic studies
Current or prior use of immunosuppressive medication within 14 days prior to first study dose, with the exception of intranasal and inhaled corticosteroids or systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent. Steroids as premedication for hypersensitivity reactions due to radiographic contrast agents are allowed.
Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid; live attenuated vaccines within 30 days of durvalumab dosing (ie, 30 days prior to the first dose, during treatment with durvalumab and for 30 days post discontinuation of durvalumab); inactivated vaccines, such as the injectable influenza vaccine, are permitted
Current or prior use of immunosuppressive medication within 21 days before the first dose of PD 0360324, with the exceptions of intranasal and inhaled corticosteroids and systemic corticosteroids at physiological doses (defined as not exceeding 10 mg/day of prednisone, or an equivalent dose of over corticosteroid)
Current or prior use of immunosuppressive medication within 14 days before step 1 registration, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
Current or prior use of immunosuppressive medication within 28 days before the first dose of MEDI4736, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
Current or prior use of immunosuppressive medication within 28 days before the first dose of treatment, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
Patients must not have received any immunosuppressive medication within 28 days prior to sub-study registration and must not be planning to receive any such agents while on protocol treatment; however, intranasal and inhaled corticosteroids or systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent are allowed
Patients must not have received any immunosuppressive medication within 28 days prior to RE-TREATMENT registration and must not be planning to receive any such agents while on protocol treatment; however, intranasal and inhaled corticosteroids or systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent are allowed
Current or prior use of immunosuppressive medication within 28 days before the first dose of MEDI4736 with the exceptions of intranasal and inhaled corticosteroids, or systemic corticosteroids in Cohort C
Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid; steroid pre-medication for CT scan contrast or study drug, is allowable, regardless of dose
Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab (MEDI4736) or tremelimumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone or any corticosteroid for less than 4 consecutive days
Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab or durvalumab and tremelimumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid; patients who have received acute, low dose, systemic immunosuppressant medications (e.g., dexamethasone for nausea or steroids as CT scan contrast premedication) may be enrolled
Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic (oral or iv) corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab or tremelimumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid (steroids as pre-med for hypersensitivity reactions eg. computed tomography (CT) scan premedication is acceptable)
Current or prior use of immunosuppressive medication within 14 days of treatment on protocol, with the exception of intranasal and inhaled corticosteroids or oral corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
Current or prior use of immunosuppressive medication within 14 days prior to first study dose, with the exception of intranasal and inhaled corticosteroids or systemic corticosteroids at doses not to exceed 10 mg/day of prednisone or equivalent. Steroids as premedication for hypersensitivity reactions due to radiographic contrast agents are allowed.
Patients should not require concurrent therapeutic doses of steroids (> 20 mg of prednisone/day or equivalent) unless they need them for the indications; steroids should be discontinued for 14 days before starting protocol treatment
Requirement, at the time of study entry, for concurrent steroids > 10 mg/day of oral prednisone or the equivalent, except steroid inhaler, nasal spray or ophthalmic solution
Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of the trial treatment (with the exception of subjects with adrenal insufficiency, who may continue corticosteroids at physiologic replacement dose, equivalent to ? 10 mg prednisone daily). Note: Previous or ongoing administration of systemic steroids for the management of an acute allergic phenomenon is acceptable as long as it is anticipated that the administration of steroids will be completed in 14 days, or that the daily dose after 14 days will be ?10 mg per day of prednisone or equivalent.
Is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment\r\n* Physiologic doses of steroids (e.g. =< 10 mg prednisone/day or equivalent) are allowed; topical, inhaled, nasal and ophthalmic steroids are allowed
The use of systemic glucocorticoids in excess of 10 mg/day equivalent of prednisone is permitted provided it is not for the treatment of GVHD (e.g. chronic obstructive pulmonary disease, anti-emetic, infusion reactions). The chronic use of topical, inhaled, and locally injected steroids is permitted
Immunosuppressive doses of systemic medications, such as steroids or absorbed topical steroids (doses greater than 7.5 to 10 mg/day prednisone or equivalent) must be discontinued at least 2 weeks before study drug administration.
Subjects receiving immunologically based treatment for any reason, including chronic steroids or prednisone (at dose > 10 mg/day of prednisone) within 14 day prior to first study treatment; inhaled or topical steroids or systemic steroids (at dose =< 10 mg/day of prednisone) is permitted
Evidence of clinically significant immunosuppression such as the following:\r\n* Primary immunodeficiency state such as severe combined immunodeficiency disease\r\n* Concurrent opportunistic infection\r\n* Receiving systemic immunosuppressive therapy (> 2 weeks) including oral steroid doses > 10 mg/day of prednisone or equivalent within 2 months prior to enrollment; (steroids for pre-medication for imaging studies are allowed).
Subjects receiving prednisone or steroids must continue on the same dose they were receiving at the time of screening
Patients receiving systemic chronic steroid therapy or any immunosuppressive therapy (? 10mg/day prednisone or equivalent). Topical, inhaled, nasal and ophthalmic steroids are allowed.
Patients who are receiving additional immunosuppressive therapy or any steroids (except concurrent corticosteroid usage if no more than 20 mg per day, prednisolone equivalent is applied)
Patient may not have received prior systemic chemotherapy for LCH or other malignant disorder; systemic steroids equivalent to prednisone 1 mg/kg/day cannot have been given for more than 7 days in the 30 day period prior to study enrollment; however, patients who have only received surgical or radiation therapy, intralesional injection of steroids, or topical steroids may be enrolled
Systemic steroids that have not been stabilized to the equivalent of =< 10 mg/day prednisone prior to the start of the study drugs
Prior treated CNS metastases must be without MRI evidence of recurrence for at least 4 weeks after treatment; patients must be off immunosuppressive doses of systemic steroids (>= 10 mg/day prednisone or equivalent) for at least 14 days prior to study drug administration, and must have returned to neurologic baseline status postoperatively\r\n* The 4-week period of stability is measured after the completion of the neurologic interventions (ie, surgery and/or radiation)
In addition to neurosurgery to treat CNS metastases, adjuvant radiation after the resection of CNS metastasis is allowed; immunosuppressive doses of systemic steroids (doses > 10 mg/day prednisone or equivalent) must be discontinued at least 14 days before study drug administration
Patients that require decadron > 4 mg/ day or equivalent of steroids.
Patients may be on steroids prior to initiation of treatment, provided that, by cycle 1 day 1, steroid use is tapered down to less than or equal to 10 mg/day of prednisone
Require systemic pharmacologic doses of corticosteroids greater than the equivalent of 10 mg/day prednisone; topical, ophthalmologic and inhalational steroids are permitted. Subjects who have a history of adrenal insufficiency and are receiving greater than 10 mg/day prednisone may be eligible but only after Sponsor consultations. Subjects who are currently receiving steroids at a dose of ? 10 mg/day do not need to discontinue steroids prior to enrollment
Subjects with immunotherapy related adverse events requiring high doses of steroids (? 40 mg/day of prednisone) are not eligible.
Patients who require anticoagulation or systemic steroids at doses >10 mg daily of prednisone or equivalent or any immunosuppressive drugs. Beta-blocker therapy, while not exclusionary, is discouraged and alternatives should be sought if possible. The beta-blocker might compromise use of epinephrine for the rare possibility of anaphylaxis.
The treating physician expects that the patient will not require more than physiologic replacement dose of steroids defined as 32 mg of cortisone per day or its equivalent
Patients who take any immune or bone marrow suppressive agents including any systemic corticosteroid that exceed an equivalent of 10 mg prednisone per day within 2 weeks from the study treatment. Inhalation or topical steroids are allowed.
Patients may not receive ? 20 mg of prednisone or equivalent between days -7 and +28 of UCART123 infusion. Hydrocortisone required for mineralocorticoid replacement therapy is authorized at all times as needed clinically. Topical, inhaled, or nasal route of steroids are permitted;
Concurrent systemic steroid therapy if greater than the equivalent of 5 mg prednisone orally (PO) daily; patients previously on steroids must be off steroids for four weeks prior to treatment
Patients may not receive ? 20 mg of prednisone or equivalent between days -7 and +28 of UCART123 infusion. Hydrocortisone required for mineralocorticoid replacement therapy is authorized at all times as needed clinically. Topical, inhaled, or nasal route of steroids are permitted;
Asymptomatic off steroids for at least 10 days except patients: a) who have mild symptoms from intracranial disease that do not affect their performance status; or b) who are asymptomatic, but require steroids for control of symptoms on a maximum dose of dexamethasone 4mg/day orally (PO) or equivalent
Use of systemic chronic steroid therapy (?10mg /day of prednisone or equivalent), or any immunosuppressive therapy within 7 days of first dose of study treatment. Topical, inhaled, nasal, or ophthalmic steroids are allowed.
Not currently requiring systemic corticosteroid therapy (10 mg or less of prednisone or equivalent doses of other systemic steroids are allowed) or any other immune suppressive medications
Subject using chronic systemic steroids greater than the equivalent of 10 mg of prednisone/prednisolone per day in the 2 weeks preceding study entry; replacement doses of steroids, topical, inhalational, nasal and ophthalmic steroids are permitted
Patients may receive steroids to control symptoms related to central nervous system (CNS) involvement, but the dose must be =< 4 mg per 24 hours of dexamethasone (or the equivalent). Patient’s symptoms should experience stability of neurological symptoms for at least 7 days, or on tapering dose of steroids. Physiologic replacement doses for adrenal insufficiency is allowed on this protocol
No use of systemic steroids greater than the equivalent of 10 mg of prednisone/prednisolone per day within 4 weeks prior to enrollment
Patients with treated, non-progressive brain metastases, off high-dose steroids (>20 mg prednisone or equivalent) for at least 4 weeks can be enrolled in the trial.
Patients may be on steroids prior to initiation of treatment, provided that, by cycle 1 day 1, steroid use is tapered down to less than or equal to 20 mg/day of prednisone
Brain metastases that are clinically unstable (e.g. showing unequivocal growth on imaging, requiring radiation therapy, or steroids >10mg of prednisone equivalent) within 4 weeks of first dose of study drug.
No steroids are permitted within 28 days of C1D1; or doses < 10 mg/day prednisone equivalent or levels necessary for physiologic replacement
Patients who are on high-dose steroids (doses > 10 mg/day of prednisone or equivalent) or immune suppression medications; NOTE: Patients on high-dose steroids (doses > 10 mg/day of prednisone or equivalent) or immune suppression medications are eligible provided these drugs are discontinued at least 3 days prior to starting on the study drugs
Able to be off of corticosteroids (10 mg or less of prednisone or equivalent doses of other systemic steroids are allowed) and any other immune suppressive medications beginning on day -3
Patients may be on steroids prior to initiation of treatment, provided that, by cycle 1 day 1, steroids use was tapered down to less than or equal to 20 mg of prednisone
PRIOR TO LYMPHODEPLETION: Current use of systemic corticosteroids at doses ? 10 mg prednisone daily or its equivalent; those receiving < 10 mg daily may be enrolled at discretion of investigator; inhaled steroids are allowed\r\n* For pediatric patients, physiologic replacement hydrocortisone at doses 6-12 mg/m^2/day is allowed; equivalently dosed alternative steroids are allowed at discretion of investigator, though not to exceed 10mg prednisone per day; inhaled steroids are allowed
PRIOR TO INFUSION OF ATLCAR.CD30 CELLS: Current use of systemic corticosteroids at doses ? 10 mg prednisone daily or its equivalent; those receiving < 10 mg daily may be enrolled at discretion of investigator; inhaled steroids are allowed\r\n* For pediatric patients, physiologic replacement hydrocortisone at doses 6-12mg/m^2/day is allowed; equivalently dosed alternative steroids are allowed at discretion of investigator, though not to exceed 10mg prednisone per day; inhaled steroids are allowed
If patient is on steroids, patient must be on a stable or decreasing dose of steroids for 5 days, no more than 2 mg dexamethasone (or equivalent) total per day at the time of screening and consent; if on steroids at the time of screening, the dose will need to be tapered and discontinued at least 5 days prior to CMV T cell infusion
Steroids within 3 weeks prior to event 1, except:\r\n* =< 10 mg prednisone or equivalent per day\r\n* Steroid with little to no systemic absorption (ie, topical or inhaled steroids)
Patients who are on steroids (> 10 mg/day or equivalent) or immune suppression medications
At least 2 weeks from prior therapy to time of start of treatment; prior therapy includes steroids (except prednisone or equivalent - up to 10 mg per day is allowed)
Clinical status at enrollment to allow tapering of steroids to less than 0.5 mg/kg/day of prednisone
Patients who are on high dose steroid (> 10 mg daily of prednisone or equivalent) or immune suppression medications; Note: patients on high-dose steroids (doses > 10mg/day of prednisone or equivalent) or immune suppression medications are eligible provided these drugs are discontinued at least 3 days prior to starting on the study drugs
Patients receiving systemic steroids ? 10mg/day of prednisone or the equivalent
Clinical status at enrollment to allow tapering of steroids to equal or less than 0.5 mg/kg/day prednisone (or equivalent).
No autoimmune disease or chronic steroids (dose of > 10 mg/day prednisone equivalent) or other immunosuppressive medications within 7 days of randomization (for MSI-H nivolumab group)
Clinical status at enrollment to allow tapering of steroids equal to or less than 0.5 mg/kg/day of prednisone
Clinical status to allow tapering of steroids to less than 0.5 mg/kg/day prednisone or equivalent
Clinical status at enrollment to allow tapering of steroids to equal or less than 0.5 mg/kg/day prednisone (or equivalent)
Patients must be off systemic immunosuppressive medications > 2 weeks prior to treatment start; if patients are in systemic corticosteroids and must be on a dose of prednisone 5 mg/day or less (or equivalent), then patients must be on this reduced dose for > 1 week prior to treatment start; topical steroids are allowed
Systemic chronic steroid therapy (? 10mg/day prednisone or equivalent) or any immunosuppressive therapy 7 days prior to planned date for first dose of study treatment. Topical, inhaled, nasal and ophthalmic steroids are allowed.
?2 weeks for topical therapy (including steroids, retinoids, nitrogen mustard or imiquimod) Topical steroids (maximum strength: medium potency) and oral steroids (?10 mg prednisone equivalent/day) are allowed, if the patient has been on a stable dose with stable symptoms for at least 4 weeks prior to study entry.
Concomitant corticosteroid use, systemic or topical, for treatment of skin disease. However, topical steroids (maximum strength: medium potency) and oral steroids (?10 mg prednisone equivalent/day) are allowed, if patient has been on a stable dose with stable symptoms for at least 4 weeks prior to study entry.
Concurrent use of systemic steroids with the exception of chronically administered steroids equivalent to ? 10 mg/day prednisone if patient has been on this therapy for ?1month
Receiving systemic steroids exceeding 10 mg prednisone or equivalent, or unstable on steroid medication, during the 3 weeks immediately preceding enrollment
Dexamethasone at cumulative doses of greater than 160 mg or equivalent <3 weeks prior to study Day 1 is not allowed. Use of topical or inhaled steroids is acceptable
Patients receiving systemic steroids ? 10mg/day of prednisone or the equivalent
Previous autoimmune complication from PD-1 or PD-L1 requiring discontinuation of therapy or treatment with steroids (ongoing treatment with more than 10 mg of prednisone or steroid equivalent daily, excluding inhaled or topical steroids).
Patients must not be receiving concurrent steroids > 10 mg prednisone (or equivalent)\n             per day.
Immunosuppressive doses of systemic medications, such as steroids or absorbed topical steroids (doses > 10 mg/day prednisone or equivalent) must be discontinued at least 2 weeks before study drug administration
Immunosuppressive doses of systemic medications, such as steroids or absorbed topical steroids (doses > 10 mg/day prednisone or equivalent) must be discontinued at least 2 weeks before study drug administration
No systemic cytotoxic chemotherapy within 4 weeks of enrollment or systemic steroids (except stable doses of prednisone =< 20 mg/day, or up to 4 doses of steroid given for non-therapy reasons) within 4 weeks of enrollment
Steroids: Therapeutic systemic doses of steroids must be stopped > 72 hours prior to CTL019 infusion. However, the following physiological replacement doses of steroids are allowed: < 12 mg/m2/day hydrocortisone or equivalent
Steroids: Therapeutic doses of steroids must be stopped > 72 hours prior to CTL019 infusion. However, the following physiological replacement doses of steroids are allowed: < 6 - 12 mg/m2/day hydrocortisone or equivalent
Steroids: Therapeutic doses of steroids must be stopped > 72 hours prior to CTL019 infusion. However, the following physiological replacement doses of steroids are allowed: < 12 mg/m2/day hydrocortisone or equivalent
Subjects with Immunotherapy related adverse events requiring high doses of steroids (? 40 mg/day of prednisone) are not eligible
Concurrent systemic therapy with steroids or other immunosuppressive agents, or use of any investigational drug within 28 days before the start of trial treatment. Short-term administration of systemic steroids (that is, for allergic reactions or the management of immune-related adverse events [irAE]) while on study is allowed. Also, subjects requiring hormone replacement with corticosteroids for adrenal insufficiency are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses <= 10 mg or equivalent prednisone per day. Note: Subjects receiving bisphosphonate or denosumab are eligible.
Patients must not be receiving chronic treatment (equivalent of prednisone > 10 mg/day) with systemic steroids or other immuno-suppressive agent
Immunosuppressive doses of systemic medications, such as steroids or absorbed topical steroids (doses > 10 mg/day prednisone or equivalent) must be discontinued at least 2 weeks before study drug administration
Chronic oral or systemic steroid medication use at a dose of > 10 mg/d of prednisone or equivalent (steroids with low systemic absorption [e.g. triamcinolone hexacetonide] injected into joint space are allowed)
Clinical status at enrollment to allow tapering of steroids to less than 0.5 mg/kg/day prednisone at time of treatment
Patients requiring chronic treatment with systemic steroid therapy, other than replacement dose steroids or treatment with low, stable dose of steroid (<10 mg/day prednisone or equivalent) for stable CNS metastatic disease.
Steroids (at prednisone equivalent doses > 10 mg) are not permitted 3 days prior to T cell infusion and concurrently during therapy. Exceptions include use of systemic prednisone equivalent doses =< 10 mg/ day, topical steroids or physiologic replacement dose of steroids for adrenocortical deficiency.
Patients who are on high-dose steroids (doses > 10 mg/day of prednisone or equivalent) or immune suppression medications; Note: patients on high-dose steroids (doses > 10mg/day of prednisone or equivalent) or immune suppression medications are eligible provided these drugs are discontinued at least 3 days prior to starting on the study drugs
Patients must be on a stable or decreasing dose of corticosteroids for 5 days prior to enrollment; patient may be taking therapeutic doses of steroids during the initial dose escalations and prior to defining an RP2D; this should be recorded in the database; once the RP2D has been established, enrollment may be limited based on steroid use;*physiologic replacement doses will be defined on this protocol as no more than 0.75 mg/m^2/day of dexamethasone or equivalent of steroids; doses higher than this will be considered therapeutic
Patients who are on chronic steroids for unrelated conditions (i.e. rheumatologic conditions) are not eligible if their total daily dose of steroids is >= 10 mg prednisone
Ongoing treatment with chronic immunosuppressants (eg, cyclosporine) or systemic steroids > 20 mg prednisone (or equivalent) QD
No chronic use of systemic steroids greater than the equivalent of 10 mg of prednisone/prednisolone per day within 4 weeks prior to enrollment
Use of systemic steroids at an equivalent dose of prednisone 5 mg/day or higher at randomization
Systemic steroids that have not been stabilized to the equivalent of =< 10 mg/day of prednisone 7 days prior to the initiation of the trial
Chronic systemic steroids (>10 mg/day Prednisone equivalents) or any other immunosuppressive agents
Short term (<30 days) concurrent systemic steroids ?0.25 mg/kg prednisone per day (maximum 7.5 mg/day) and bronchodilators (inhaled steroids) are permitted; other steroid regimens and/or immunosuppressives are excluded while receiving vaccine. Patients requiring steroids following previous CNS radiation for metastatic disease are excluded.
Patients must be tapered off systemic steroids to a dosage of less than or equal to 0.25 mg/kg/day
Any condition requiring chronic use of moderate/high dose steroids (equivalent to 10 mg QD prednisone).
Immunosuppressive doses of systemic medication, such as steroids or absorbed topical steroids (doses > 10 mg/day prednisone or equivalent) must be discontinued at least 14 days prior to nivolumab administration
Concurrent use of other anti-cancer agents or treatments. NOTE: Growth factors and bisphosphonates are allowed as medically indicated. Steroids may be used with an equivalency of up to 20 mg of Prednisone per day as long as the dose has not been adjusted upwards in past 2 weeks prior to study registration.
Clinical status at enrollment to allow tapering of steroids to equal or less than 0.5 mg/kg/day prednisone (or equivalent).
Prior treated CNS metastases must be without MRI evidence of recurrence for at least 4 weeks after treatment. Patients must be off immunosuppressive doses of systemic steroids (? 10 mg/day prednisone or equivalent) for at least 14 days prior to study drug administration, and must have returned to neurologic baseline status postoperatively. • The 4-week period of stability is measured after the completion of the neurologic interventions (ie, surgery and/or radiation).
In addition to neurosurgery to treat CNS metastases, adjuvant radiation after the resection of CNS metastasis is allowed. Immunosuppressive doses of systemic steroids (doses ? 10 mg/day prednisone or equivalent) must be discontinued at least 14 days before study drug administration.
Clinical status at enrollment to allow tapering of steroids to less than 0.5 mg/kg/day prednisone
Treatment with oral steroids (dose ? 10 mg/day of methylprednisolone or equivalent)
Requirement, at time of study entry, for concurrent steroids > 10 mg/day of oral prednisone or the equivalent, except steroid inhaler, nasal spray, or ophthalmic solution
Patients who are on chronic steroids for unrelated conditions (i.e. rheumatologic conditions) are not eligible if their total daily dose of steroids is equivalent to greater than 10 mg prednisone
Use of systemic steroids at an equivalent dose of prednisone 5 mg/day or higher within 6 weeks of day 1 of protocol therapy
Patients may be on steroids prior to initiation of treatment as long as by cycle 1 day 1 steroids use was tapered down less than or equal to 20 mg of prednisone
Patients who are on high-dose steroids (doses > 10 mg/day of prednisone or equivalent) or immune suppression medications; Note: patients on high-dose steroids (doses > 10mg/day of prednisone or equivalent) or immune suppression medications are eligible provided these drugs are discontinued at least 3 days prior to starting on the study drugs
Clinical status at enrollment to allow tapering of steroids to less than 0.5 mg/kg/day prednisone
Chronic use of steroids at immunosuppressive doses. (Note, physiologic replacement doses of glucocorticoid or mineralocorticoid are acceptable, eg. prednisone 5-10 mg/day; fludrocortisone 0.1-0.2 mg/day)
Require, at the time of study entry, treatment with steroids > 10 mg/day of oral prednisone (or equivalent), except topical use, steroid inhaler, nasal spray or ophthalmic solution
Systemic steroids at physiologic doses (equivalent to dose of oral prednisone 10 mg) are permitted. Steroids as anti-emetics for chemotherapy are not allowed.
Subjects with a condition with anticipated use of systemic steroids above the equivalent of 10 mg prednisone are excluded.
Require systemic pharmacologic doses of corticosteroids at or above the equivalent of 10 mg/d prednisone; replacement doses, topical, ophthalmologic and inhalational steroids are permitted. Subjects who have a history of adrenal insufficiency and are receiving greater than 10 mg/day systemic steroids may be eligible but only after Sponsor consultation.
Any medical condition for which prednisone (corticosteroid) is contraindicated
Systemic corticosteroid use within 7 days before planned start of study therapy
Patients have had no previous treatment except corticosteroid use
Off or low dose (=< 4 mg/day by Decadron) corticosteroid for at least for 2 weeks before the first pre-surgical vaccine
Ongoing corticosteroid use.
?28 days for prior systemic corticosteroid therapy.
?7 days for immune-suppressive-based treatment for any reason. Note: Use of inhaled or topical corticosteroid use for radiographic procedures is permitted. Note: The use of physiologic corticosteroid replacement therapy may be approved after consultation with the sponsor.
Untreated or symptomatic brain metastases requiring corticosteroid therapy (no corticosteroid use for this purpose in the preceding 4 weeks)
Use of systemic corticosteroid therapy within 2 weeks of study enrollment, including patients receiving replacement corticosteroid therapy; note: only topical, inhaled and intranasal steroid therapy is permitted
Corticosteroid therapy for 7 days prior to enrollment
Any patient receiving chronic corticosteroid administration prior to study enrollment is ineligible
Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated.
Patients requiring corticosteroid therapy at a dose of 15 mg or more per day of prednisone or the equivalent; pulsed corticosteroid dose for disease control is acceptable
Patients must require no corticosteroid therapy or dose of less than 15 mg per day of prednisone or the equivalent; pulsed corticosteroid dose for disease control is acceptable until the day before the start of lymphodepletion
Patients who require or are likely to require corticosteroid or other immunosuppressive drugs for intercurrent disease (any other significant medical problem related to or independent from the neuroblastoma or its treatment) while tentatively scheduled to receive treatment on this study are ineligible; the only exception is for patients known to require 2 mg/kg or less of hydrocortisone (or an equivalent dose of an alternative corticosteroid) as premedication for blood product transfusion in order to avoid allergic transfusion reactions
FOR ALL PHASES (Ib AND II): Systemic continuous corticosteroid therapy at a daily dose higher than 15 mg prednisone or equivalent is not allowed; patients may be using topical or inhaled corticosteroids; previous corticosteroid therapy must be stopped or reduced to the allowed dose at least 7 days prior to the first study drug administration; if a patient is on chronic corticosteroid therapy, corticosteroids should be de-escalated to the maximum allowed dose after the patient has signed the consent document
Systemic corticosteroid therapy of any dose is not allowed within 14 days prior to the required leukapheresis, or the initiation of the conditioning chemotherapy regimen; corticosteroid creams, ointments, and eye drops are allowed
Corticosteroid use =< 2 weeks prior to registration; NOTE: patients must be off corticosteroids for at least 2 weeks prior to registration; this includes oral, IV, subcutaneous, or inhaled route of administration; patients on chronic corticosteroid for adrenal insufficiency or other reasons may enroll if they receive less than 10 mg/day of prednisone (or equivalent)
Patients who fail corticosteroid taper defined as fulfilling either one of the following criteria:
Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone/ prednisolone once daily
Patients requiring ongoing daily corticosteroid therapy at a dose of > 15 mg of prednisone per day (or equivalent); pulsed corticosteroid use for disease control is acceptable
EXCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): Patients requiring ongoing daily corticosteroid therapy at a dose of > 15 mg of prednisone per day (or equivalent); pulsed corticosteroid use for disease control is acceptable
EXCLUSION CRITERIA FOR TNBC: Patients requiring ongoing daily corticosteroid therapy at a dose of > 15 mg of prednisone per day (or equivalent); pulsed corticosteroid use for disease control is acceptable
Systemic corticosteroid steroid therapy of any dose is not allowed within 14 days prior to the required leukapheresis, or the initiation of the conditioning chemotherapy regimen; corticosteroid creams, ointments, and eye drops are allowed
Corticosteroid use > 4 mg/day at time of consent
Immunosuppressive corticosteroid doses (>10mg prednisone) within 28 days prior to treatment with REGN2810
Corticosteroid use within 2 weeks of study treatment
TREATMENT: Patients receiving systemic corticosteroid within 48 hours of CTL infusion
Patients requiring ongoing daily corticosteroid therapy at a dose of > 15 mg of prednisone per day (or equivalent); pulsed corticosteroid use for disease control is acceptable
Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone/prednisolone bid
Patients currently receiving chronic corticosteroid treatment (longer than 8 weeks duration) for management of pre-existing adverse events, or patients with a history of chronic corticosteroid treatment longer than 8 weeks' duration for AEs within 6 months of Screening are excluded
Chronic systemic corticosteroid use (ie, prednisone > 10 mg QD or the equivalent of longer duration than 8 weeks for any medical condition) or history of chronic corticosteroid use (longer than 8 weeks duration) within the past 6 months; treatment for well-controlled and asymptomatic adrenal insufficiency is permitted, but replacement dosing is limited to prednisone ? 10 mg QD or the equivalent, and patients must have no history of adrenal crisis. Local steroid therapies (eg, otic, ophthalmic, intra-articular or inhaled medications) are acceptable
Chronic use of high-dose oral corticosteroid therapy .
Chronic adrenal failure or is receiving concurrent long-term corticosteroid therapy.
Prior cytotoxic therapies are NOT allowed; the only exception is prior corticosteroid therapy (prednisone up to 1 mg/kg for =< 3 months) which must be stopped at least 1 week prior to study enrollment
Concurrent systemic corticosteroid therapy within 4 weeks prior to randomization, except prophylactic use of steroids prior to paclitaxel administration
Patient is on any systemic corticosteroid therapy within one week before the planned date for first dose of treatment or on any other form of immuno-suppressive medication
Treatment with systemic corticosteroid or immune-modulators =< 30 days prior to randomization
Chronic systemic or regular inhaled corticosteroid use within 7 days prior to initiation of protocol therapy
Systemic anti-myeloma therapy including systemic corticosteroid steroid therapy of greater than 5 mg/day of prednisone or equivalent dose of another corticosteroid are not allowed within 2 weeks prior to the required leukapheresis
Systemic corticosteroid steroid therapy of greater than 5 mg/day of prednisone or equivalent dose of another corticosteroid are not allowed within 2 weeks prior to either the required leukapheresis or the initiation of the conditioning chemotherapy regimen
Current corticosteroid (other than replacement doses in patients who are hypo-adrenal) or other immunosuppressive therapy
Current need for chronic corticosteroid therapy or other immunosuppressive agents (>= 10 mg of prednisone daily or an equivalent dose of other corticosteroid), or patients who have received systemic corticosteroids =< 2 weeks prior to starting study drug
Completed treatment with systemic corticosteroid or immune-modulators < 30 days prior to registration;
Use of systemic corticosteroid.
Subjects on immunosuppressive medications such as azathioprine, mycophenolate mofetil, cyclosporine or require chronic corticosteroid use (defined as ? 3 months of prednisone dose equivalent of ? 10 mg).
No oral or intravenous corticosteroid use within 2 weeks prior to study entry
Pre-existing condition that warrants long-term corticosteroid use; physiologic replacement is not permitted
Systemic corticosteroid (inhalers are allowed) within 7 days before the first dose of study drug.
Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone/prednisolone bid.
Medical condition that would make prednisone (corticosteroid) use contraindicated
Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone bid
Have a pre-existing condition that warrants long-term corticosteroid use; inhaled steroids are allowed
Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
Have a pre-existing condition that warrants long-term corticosteroid use in excess of study dose
Stable dose of non-corticosteroid immunosuppressants for the 2 weeks prior to first dose of AMG 592.
Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone/prednisolone bid
Have received systemic corticosteroid (inhalers are allowed) within 7 days before the first administration of study drug
Current need for chronic corticosteroid therapy (>= 10 mg of prednisone daily or an equivalent dose of other corticosteroid), or patients who have received systemic corticosteroids =< 2 weeks prior to starting study drug
Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
Have a pre-existing condition that warrants long-term corticosteroid use in excess of study dose
Pre-existing condition that warrants long-term corticosteroid use in excess of study dose
Systemic corticosteroid therapy (ongoing)
No increase in corticosteroid dose in the week prior to baseline brain imaging
Known treatment with systemic corticosteroid within one week prior to the first administration of study drug
Patients on immunosuppressive drugs (with exception of corticosteroid)
No previous radiotherapy or chemotherapy other than corticosteroid therapy
Corticosteroid monotherapy for lymphoma within 1 week of the first dose of study drug
Chronic or high-dose corticosteroid therapy
Patients who are on (or will require) prolonged systemic corticosteroid treatment during the study, except for:
History of chronic corticosteroid use
Continuous corticosteroid therapy within 21 days prior to first dose of orteronel
Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
Patients with a pre-existing condition that warrants long-term corticosteroid use in excess of study dose
Systemic corticosteroid therapy <7 days prior to first dose of the study medication
Have received a systemic corticosteroid within one week prior to the first administration of study drug;
Need for current chronic corticosteroid therapy
Patients on immunosuppressive drugs (with exception of corticosteroid)
Stable dose of corticosteroid >= 14 days prior to registration
Chronic systemic corticosteroid use (>14 days) at the time of study enrollment.
Any expected corticosteroid use during study enrollment at higher doses than will be used in this study.
Concurrent systemic corticosteroid therapy;
Subjects who have concurrent illness requiring systemic corticosteroid use other than the planned dexamethasone during conditioning therapy
Corticosteroid use > 10 mg prednisone/day
Chronic systemic corticosteroid use (> 14 days) at the time of study enrollment
Corticosteroid within the past 30 days prior to registration on this study for greater than one week duration
Patient must be willing to remain on corticosteroid therapy for 4 days postoperatively
Patient who has been started on systemic corticosteroid therapy within 72 h prior to study drug administration or is planned to receive a corticosteroid as part of the chemotherapy regimen
Has started on systemic corticosteroid therapy within 72 hours prior to study drug administration or is expected to receive a corticosteroid as part of the chemotherapy regimen
Has not received Dex or another corticosteroid in over 4 weeks prior to enrollment
Systemic corticosteroid therapy within 7 days before enrollment.
Patients requiring chronic treatment with systemic steroid therapy, other than replacement dose steroids in the setting of adrenal insufficiency or treatment with low, stable dose of steroid (<10mg/ day prednisone or equivalent) for stable CNS metastatic disease.
Requirement for concomitant high dose corticosteroids\r\n* EXCEPTION: Patients may be on chronic steroids (maximum dose 20 mg/day prednisone equivalent) if they are being given for adrenal insufficiency, rheumatoid arthritis, etc
REGISTRATION TO TREATMENT (STEP 1): No current use of corticosteroids; EXCEPTION: Low doses of steroids (< 10 mg of prednisone or equivalent dose of other steroid) used for treatment of non-hematologic medical condition (e.g. chronic adrenal insufficiency) is permitted
REGISTRATION TO TREATMENT (STEP 2): No current use of corticosteroids; EXCEPTION: Low doses of steroids (< 10 mg of prednisone or equivalent dose of other steroid) used for treatment of non-hematologic medical condition (e.g. chronic adrenal insufficiency) is permitted
Concomitant high dose corticosteroids except patients may be on chronic steroids (maximum dose 10 mg/day prednisone equivalent) if they are being given for disorders other than myeloma, e.g. adrenal insufficiency, rheumatoid arthritis, etc
Requirement for other concomitant chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered to be investigational or which would be considered as a treatment of AL amyloidosis. However, participants may be on chronic steroids (maximum dose 20 mg/day prednisone or equivalent) if they are being given for disorders other than amyloidosis (eg, adrenal insufficiency, rheumatoid arthritis, etc.).
Planned concurrent treatment with systemic high dose corticosteroids; patients may be on a stable low dose of steroids (< 10 mg equivalent of prednisone) for chronic respiratory conditions
No current use of corticosteroids; EXCEPTION: low doses of steroids (< 10 mg of prednisone or equivalent dose of other steroid) used for treatment of non-hematologic medical condition (e.g. chronic adrenal insufficiency) is permitted
Concomitant high dose corticosteroids other than what is part of treatment protocol (concurrent use of corticosteroids); EXCEPTION: patients may be on chronic steroids (maximum dose 20 mg/day prednisone equivalent) if they are being given for disorders other than myeloma, i.e., adrenal insufficiency, rheumatoid arthritis, etc
Ongoing therapy with chronic or high dose corticosteroids. Low dose steroids (i.e. prednisone ? 10 mg or an equivalent steroid dose), inhaled and topical steroids are permitted
Concomitant high dose corticosteroids (concurrent use of corticosteroids); EXCEPTION: patients may be on chronic steroids (maximum dose 20 mg/day prednisone equivalent) if they are being given for disorders other than amyloid, i.e., adrenal insufficiency, rheumatoid arthritis, etc.
Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational; NOTE: Bisphosphonates are allowed while on protocol treatment; patients may be receiving stable doses of corticosteroids with a maximum dose of 10 mg of prednisone per day if they are being given for disorders other than lymphoma such as rheumatoid arthritis, polymyalgia rheumatica or adrenal insufficiency, or asthma
Concomitant high dose corticosteroids (concurrent use of corticosteroids) while on single agent ibrutinib; EXCEPTION: patients may be on chronic steroids (maximum dose 20 mg/day prednisone equivalent) if they are being given for disorders other than amyloid, (i.e., adrenal insufficiency, rheumatoid arthritis, etc)
The subject has received systemic dexamethasone continuously at a dose > 8 mg/day for 8 weeks prior to the date of the screening assessment
Receive dexamethasone equivalent dose </=2 mg per day, stable or decreased for >/= three days prior to Day 0;
Dexamethasone equivalent dose >2 mg per day;
Diagnosis of immunodeficiency or treatment with systemic immunosuppressive therapy within 28 days prior to the first dose of trial treatment, other than dexamethasone for the underlying disease under investigation, as noted in the inclusion criteria;
Recent corticosteroid therapy at a cumulative dose equivalent to >= 140 mg of prednisone or a single dose equivalent to >= 40 mg of dexamethasone within 2 weeks prior the first dose of study drug.
Stable dose of dexamethasone 2 mg or less for at least 7 days prior to initiation of treatment
Requires treatment with high dose systemic corticosteroids defined as dexamethasone > 2 mg/day or bioequivalent within at least 7 days of initiating therapy
Dexamethasone: 7 days
< 4 mg dexamethasone daily (or equivalent if on another corticosteroid) at time of start of therapy; patients on a steroid taper post-surgery and are anticipated to be on < 4 mg at time of chemoradiation initiation will be eligible to consent but to initiate treatment on trial, the participant must be on < 4 mg or equivalent of steroids otherwise participate will be deemed a screen fail and be replaced
Stable dose of dexamethasone 2 mg or less for 7 days prior to initiation of treatment
Stable dose of dexamethasone 2 mg or less for 7 days prior to initiation of treatment
Requires treatment with high dose systemic corticosteroids defined as dexamethasone > 2 mg/day or bioequivalent within 7 days of initiating therapy
Stable dose of dexamethasone 2 mg or less for at least 7 days prior to initiation of treatment
Treatment with high dose systemic corticosteroids defined as dexamethasone > 2 mg/day or bioequivalent within 7 days of initiating therapy
Stable dose of dexamethasone 2 mg or less for at least 7 days prior to initiation of treatment
Treatment with high dose systemic corticosteroids defined as dexamethasone > 2mg/day or bioequivalent within 7 days of initiating therapy
For Daratumumab + bortezomib + lenalidomide + dexamethasone (D-VRd) and Daratumumab + bortezomib + melphalan + prednisone + dexamethasone (D-VMP) regimen: newly diagnosed myeloma
The patient must be either off systemic steroids or be on stable dose of dexamethasone (max 0.1 mg/kg/day; maximum 4mg/day) at time of enrollment
Ongoing treatment with immunosuppressive drugs or dexamethasone > 4 mg
EXCLUSION CRITERIA FOR STRATUM C: Patients may not be on immunosuppressive therapy, including corticosteroids (with the exception of physiologic replacement, defined as =< 0.75 mg/m^2/day dexamethasone equivalent) at time of enrollment; however, patients who require intermittent use of bronchodilators or local steroid injections will not be excluded from the study
Daily dexamethasone > 4 mg at the time of registration
Corticosteroids use exceeding a cumulative dose of 160 mg of dexamethasone during screening
Research participant must not require more than 2 mg three times daily TID of dexamethasone on the day of PBMC collection.
Research participants must not require more than 2 mg TID of dexamethasone during CAR T cell therapy
Phase I patients must not be receiving greater than 1 mg dexamethasone/day (or an equivalent amount of an alternative corticosteroid) for at least 1 week prior to treatment start
Has a diagnosis of immunodeficiency including human immunodeficiency virus (HIV) (HIV 1/2 antibodies) and is not on continuous daily immunosuppressive therapy within 7 days prior to the first dose of trial treatment; (an exception to this is the use of steroids for brain edema and resulting symptom); subjects may receive a stable or reducing dose of steroids (up to 8 mg dexamethasone or equivalent for at least 5 days prior to signing consent) to prevent or manage cerebral edema; subjects requiring over 8mg of dexamethasone per day on or five days prior to signing consent are excluded)
Dexamethasone dose =< 4 mg daily
If applicable, stable dose of dexamethasone 2 mg or less for 7 days prior to initiation of treatment
Patients who are on dexamethasone receiving > 4 mg/day in the two weeks prior to admission for intra-cerebral delivery of PVSRIPO
Prior therapy for AL amyloidosis or multiple myeloma including medications that target CD38, with the exception of 160 mg dexamethasone (or equivalent corticosteroid) maximum exposure prior to randomization
Requires treatment with high dose systemic corticosteroids defined as dexamethasone > 4 mg/day or bioequivalent for at least 3 consecutive days within 2 weeks of registration
Dexamethasone dose should be =< 4 mg/day or steroid equivalent prior to starting treatment; if higher doses are needed, consult with study chair
Patients on greater than 4 mg per day of dexamethasone within the 2 weeks prior to admission for PVSRIPO infusion
Ongoing or recent (within 21 days prior to study entry) use of high dose oral corticosteroids (>= 2 mg of dexamethasone daily or equivalent); intranasal and/or inhaled corticosteroid use is permitted
The ability to take folic acid, vitamin B12, and dexamethasone according to protocol
Use of systemic glucocorticoid (eg, prednisone, dexamethasone) within 14 days prior to the start of study medication.
High doses of systemic corticosteroids within 7 days prior to first dosing; high dose is considered as > 20 mg of dexamethasone a day (or equivalent) for > 7 consecutive days
Participant may be receiving steroid therapy at time of enrollment (stable dose of ? 4 mg/day of dexamethasone or steroid equivalent).
Time interval from last systemic chemotherapy (not including low dose dexamethasone) more than 2 weeks prior to initiation of ABC294640; patients receiving high dose dexamethasone defined as 40 mg dexamethasone a day for 4 days will need 2 weeks washout prior to initiation of ABC294640
Is taking > 4mg/day of dexamethasone or its equivalent at the start of immunotherapy or has required > 4mg/day of dexamethasone or its equivalent for 3 consecutive days within 1 week of starting treatment
The ability to take folic acid, vitamin B12, and dexamethasone according to protocol
PHASE II DOSE EXPANSION IN RECURRENT GBM UNDERGOING RESECTION: A baseline brain MRI must be obtained no more than 14 days (+ 3 working days) prior to study enrollment; the patient must either be on no steroids or a stable dose of dexamethasone no greater than 2 mg a day for at least 5 days prior to entrance onto the study
PHASE II DOSE EXPANSION IN NEWLY DIAGNOSED GBM: A baseline brain MRI obtained no more than 14 days (+ 3 working days) prior to study enrollment on a stable dose of steroids no greater than 2 mg a day of dexamethasone for at least 5 days, is required prior to entrance of a patient onto the study; patients must be registered on the study within 5 weeks of completion of concurrent chemoradiation
Subject requires escalating or chronic supraphysiologic doses of corticosteroids > 2 mg dexamethasone or equivalent
Ability to take folic acid, vitamin B12, and dexamethasone according to the protocol instructions
AT THE TIME OF INFUSION: Subjects should have been off other investigational antineoplastic therapy for two weeks prior to entry in this study; temozolomide will be allowed up to 48 hours pre-infusion; dexamethasone up to a total dose of 2 mg per day will be allowed if medically indicated
Use of immunosuppressives within four weeks prior to study entry or anticipated use of immunosuppressive agents; dexamethasone, or other corticosteroid medications, if used in the peri-operative period must be tapered to no more than 0.1 mg/kg/day, max 4 mg/day dexamethasone for at least one week before study registration; topical corticosteroids are acceptable
Systemic corticosteroid therapy > 2 mg of dexamethasone or equivalent per day at study entry
Patients on greater than 4 mg per day of dexamethasone within the 2 weeks prior to admission for D2C7-IT infusion
Research participant must not require more than 2 mg three times daily (TID) of dexamethasone on the day of PBMC collection.
Research participants must not require more than 2 mg TID of dexamethasone during T cell therapy
Steroid use is allowed as long as dose has not increased within 2 weeks of scheduled M032 administration; whenever possible, the patient should be on a steroid dose that is equivalent to a dexamethasone dose of =< 2 mg daily at the time of treatment
Required steroid increase within 2 weeks of scheduled M032 administration; when possible, the patient should be on a dexamethasone equivalent dose of =< 2 mg daily at the time of treatment
Patients are allowed up to two cycles of high dose steroids (maximum total dose of 320 mg dexamethasone or equivalent) if needed for symptomatic disease before study enrollment
Patients currently receiving high dose systemic steroids for treatment of MM in excess of 320mg total dose of dexamethasone or equivalent, patients who received an investigational agent within 5 half-lives of the agent
Systemic corticosteroid therapy must be at a dose of =< 4 mg of dexamethasone or equivalent per day during the week prior to day 1
Patients on total daily dose of dexamethasone greater than 16 mg
Patients needing more than 8 mg dexamethasone per day at the time of start of WBRT will not be eligible to participate in the study; however, patients will be allowed entry into the study if it is medically safe to reduce the daily dose of dexamethasone to 8 mg or less from the day of the start of WBRT; the dexamethasone dose for such patients may be increased beyond 8 mg per day during the course of treatment if medically necessary; this increased need for dose should be communicated to the study’s principal investigator, Dr Mohindra at the University of Maryland
Use of immunosuppressives within four weeks prior to study entry or anticipated use of immunosuppressive agents; dexamethasone, or other corticosteroid medications, if used in the peri-operative period and/or during radiotherapy, must be tapered (no more than 0.1 mg/kg/day, max 4 mg/day dexamethasone) for at least one week before study registration; topical corticosteroids are acceptable
Medical need for the continuous administration of any drugs which affect CYP3A4 though the use of low dose glucocorticoids (e.g. dexamethasone =< 4 mg daily or equivalent) for anorexia and /or nausea is permitted
Patients who are receiving high dose steroids (more than a dexamethasone-equivalent dose of 4 mg per day).
Patients with active autoimmune diseases or active immune suppressive therapy or inflammatory bowel disease; a low dose steroid daily administration (equivalent dexamethasone < 10mg/day) is acceptable
Systemic corticosteroid therapy is permitted provided dosing is no greater than 4 mg per day (dexamethasone or equivalent) on the day of vaccine administration.
Systemic corticosteroid therapy, > 8 mg of dexamethasone daily (or equivalent) at study enrollment
Concurrent Therapy \r\n* Patients who are receiving any other anticancer or investigational drug therapy\r\n* Patients requiring systemic treatment with either corticosteroids (greater than dexamethasone 0.75 mg/m^2/day or the equivalent dose of other steroids) or other immunosuppressive medications within 14 days of study drug administration will be excluded; however, patients who require intermittent use of bronchodilators or local steroid injections will not be excluded from the study
Intolerance of dexamethasone
The subject requires dexamethasone =< 4 mg daily on a stable dose
No dexamethasone (or other corticosteroid bioequivalent) within one week of vaccination initiation
Stable topical steroid therapy with dexamethasone, clobetasol, or budesonide oral solutions (5 min, four times a day) for seven days prior to study enrollment
Concurrent use of high dose steroids; chronic steroid use of < 2 mg dexamethasone or equivalent per day is permissible
Receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment; patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., limited low-dose dexamethasone for nausea, multiple doses for contrast allergy) may be enrolled in the study and would not require a 7 day washout
Patients who are receiving dexamethasone must be on a stable dose for at least 1 week prior to study entry
A patient's daily total dose of dexamethasone must be =< 16 mg by day 4
Patients receiving chronic, systemic treatment with corticosteroids (of more than 4 mg/day or equivalent of dexamethasone; doses of dexamethasone of up to 8 mg/day may be administered for less than 2 weeks) or another immunosuppressive agent; topical or inhaled corticosteroids are allowed
Has not had prior systemic therapy for multiple myeloma. An emergency course of steroids (defined as no greater than 40 milligram [mg] of dexamethasone, or equivalent per day for a maximum of 4 days (that is, a total of 160 mg) is permitted. In addition, radiation therapy is permitted prior to study entry, during screening, and during Cycles 1-2 of study treatment as needed for lytic bone disease
Non-escalating corticosteroid dose (not exceeding more than 16 mg daily of dexamethasone oral) for >= 5 days
Participant has prior or current systemic therapy or SCT for multiple myeloma, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 mg/day for 4 days) of corticosteroids before treatment
Patients needing more than 8 mg dexamethasone per day at the time of start of WBRT will not be eligible to participate in the study; however, patients will be allowed entry into the study if it is medically safe to reduce the daily dose of dexamethasone to 8 mg or less from the day of the start of WBRT; the dexamethasone dose for such patients may be increased beyond 8 mg per day during the course of treatment if medically necessary; this increased need for dose should be communicated to the study’s principal investigator, Dr Mohindra at the University of Maryland
No more than 16 mg dexamethasone (or equivalent) per day
Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid (ie, less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of Cycle 1 Day 1), for Cohort C, the induction and consolidation treatment along with the first Autologous stem cell transplantation (ASCT) are allowed)
Participants no longer need to be able to receive intravenous (IV) dexamethasone or an equivalent IV corticosteroid
Be willing to use dexamethasone mouthwash as directed
Noncompliant with oral medication and/or dexamethasone mouth wash
Any anti-myeloma drug treatment within 14 days before randomization, including dexamethasone.
Systemic corticosteroid therapy is permitted provided dosing is no greater than 4 mg per day (dexamethasone or equivalent) on the day of vaccine administration
Intolerance to dexamethasone
Dexamethasone dose less than or equal to 4 mg daily at time of study enrollment
Immunosuppressants: patients must be receiving a stable or decreasing dose of dexamethasone for at least 1 week prior to start of therapy AND dexamethasone dose must be =< 0.1 mg/kg/day AND =< a total daily dose of 4 mg/day
Glucocorticoid therapy within the 14 days prior to randomization that exceeds a cumulative dose of 160 mg of dexamethasone or 1000 mg prednisone
Stable dose of steroids for 5 days, no more than 2 mg dexamethasone (or equivalent) total per day
Requires treatment with high dose systemic corticosteroids defined as dexamethasone > 4 mg/day or bioequivalent for at least 3 consecutive days within 2 weeks of start of study drug
Patient requires more than 8 mg of dexamethasone daily or the equivalent
Participant has prior or current systemic therapy or SCT for multiple myeloma, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 mg/day for 4 days) of corticosteroids before treatment
Foreseeable condition which would preclude the reduction of steroids (dexamethasone) to a maximum of 2 mg BID within a week prior to apheresis -
Dexamethasone at cumulative doses greater than 160 mg or equivalent within 14 days prior to the first dose of study treatment is not allowed. Use of topical or inhaled steroids is acceptable.
Patients on total daily dose of dexamethasone greater than 16 mg/day
Intolerance of vitamin B12, folic acid or dexamethasone
Up to one cycle of prior therapy is allowed (maximum of 160 mg total dexamethasone [dex] [or equivalent amount of prednisone]), 4 days of melphalan, 4 doses of cyclophosphamide and/or 4 doses of Velcade; at least 4 weeks (wks) has to have had passed since last dose of melphalan, 2 weeks since last Velcade or glucocorticoid dose
Patients taking greater than 12 mg daily of dexamethasone
The ability to take folic acid, vitamin B12, and dexamethasone according to protocol for all pemetrexed arms
Stable dose of glucocorticoids pre-therapy; if patients are receiving dexamethasone, the dose of dexamethasone should not increase during the 96 hours prior to initiation of therapy
Patients on greater than 4 mg per day of dexamethasone within the 2 weeks prior to admission for PVSRIPO infusion
If patient is on dexamethasone, must be on stable or decreasing dose of dexamethasone for >= 7 days; if patient is on different glucocorticoid e.g., prednisone, must be converted to dexamethasone prior to enrollment
Prior treatment for myeloma except for one cycle of dexamethasone
Patients receiving corticosteroids at the time of the first vaccine, with the exception of nasal or inhaled steroid, at a dose above physiologic levels will be removed and replaced; for the purposes of this study, physiologic dose will be defined as < 2 mg of dexamethasone/day; once vaccinations have been initiated, if patients subsequently require increased steroids, they will still be permitted to remain on the study, but every effort will be made to minimize steroid requirements
Use of systemic glucocorticoid (eg, prednisone, dexamethasone) within 14 days prior to the start of study medication
Participants in the combination therapy arms must be eligible to receive pomalidomide/dexamethasone, bortezomib/dexamethasone or lenalidomide/dexamethasone or other approved agents per current prescribing information for MM.
Intolerance to dexamethasone, as determined by Investigator.
High doses of systemic corticosteroids within 7 days prior to first dosing. High dose is considered as > 20 mg of dexamethasone a day (or equivalent) for > 7 consecutive days Exclusion Criteria (Part B):
Patients with central nervous system (CNS) tumors who are receiving dexamethasone must have been on a stable or decreasing dose of dexamethasone for the 7 days prior to enrollment
Patients for whom dexamethasone is contraindicated.
Active infection or other medical condition that would make corticosteroids (i.e. dexamethasone) use contraindicated
a short duration (< 5 days) of systemic corticosteroids e.g., of chronic obstructive pulmonary disease, or as an antiemetic corresponding at maximum to the anti-inflammatory potency of 4 mg dexamethasone for treatment;
Requirement of systemic corticosteroid therapy > 4 mg/day of dexamethasone or equivalent or requirement of increasing dose of systemic corticosteroids during the 7 days prior to the start of SL-701 treatment.
Dexamethasone (or equivalent systemic steroid) higher than the physiologic dosing with 7 days before study drug administration
Glucocorticoid therapy within 14 days prior to randomization that equals or exceeds a cumulative dose of 160 mg of dexamethasone
Patients must be on a steroid dose less than or equal to 2 mg of dexamethasone daily (or equivalent), and this dose must not have increased for at least 14 days prior to obtaining the enrollment.
Systemic corticosteroid therapy > 2 mg of dexamethasone daily (or equivalent) at study enrollment.
If a patient is on corticosteroids, he/she must be on a non-escalating corticosteroid dose (not exceeding more than 16 mg daily of dexamethasone oral) for >= 5 days
Patients receiving corticosteroids aside from dexamethasone treatment directed at leukemia
Resistance to high-dose dexamethasone used in the last line of therapy
taking more than 8 mg of dexamethasone per day
Corticosteroid therapy at a dose equivalent to dexamethasone > 4 mg/day within 21 days prior to randomization
Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid [i.e., less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of randomization]).
Systemic corticosteroid therapy > 2 mg of dexamethasone or equivalent (as defined by the investigator) per day at study enrollment.
For patients on oral corticosteroids, they must be stable clinically on corticosteroids or tapered off prior to starting the study drug; for patients taking dexamethasone, the dose should not exceed 8 mg QD (or 4 mg twice daily [BID]), if clinically stable, and the dose should not be escalated over entry dose level, if clinically possible; the patient’s dose of dexamethasone will be evaluated by the principal investigator (PI), the patient’s study physician, and/or the study pharmacist on a case by case basis for safety; all doses of oral corticosteroids will be reduced by 50%, unless oral corticosteroids are at physiologic dose (e.g. dexamethasone 1 mg, prednisone 10 mg, or cortisone 30 mg); it is recommended that oral corticosteroid doses be escalated back to full dose on day 7 (2 days after aprepitant is discontinued)
Dexamethasone dose must be provided for treatment group assignment:\r\n* Group A: patients not on dexamethasone or on a dose =< 0.75 mg daily (or equivalent of an alternative corticosteroid)\r\n* Group B: patients who require dexamethasone >= 4 mg daily (or equivalent of an alternative corticosteroid)\r\n** Patients must have been on the group assignment dose of corticosteroids for at least 5 days prior to the dose of NT-I7; corticosteroid dose changes prior to the start of treatment are allowed as long as they do not alter patient’s group assignment
Use of dexamethasone for cancer related fatigue
Patient requires more than 8 mg of dexamethasone daily or the equivalent
Patients on stable doses (defined as same dose for 2 weeks) of dexamethasone, mirtazapine, zolpidem, benzodiazepines, phenothiazines are allowed to participate in the study
More than 30 days of previous treatment (before screening) with anti-myeloma therapy (does not include radiotherapy or a single short course of steroid [ie, less than or equal to the equivalent of dexamethasone 60 mg/day for 4 days]).
Hypersensitivity to dexamethasone or corticosteroids or Equal sugar substitute
Chemotherapy regimen: Doxorubicin/cyclophosphamide. Antiemetic regimen: Aprepitant + palonosetron + dexamethasone on Day 1 and aprepitant + dexamethasone on Days 2 & 3.
Chemotherapy regimen: Doxorubicin/cyclophosphamide/docetaxel. Antiemetic regimen: Aprepitant + palonosetron + dexamethasone on Day 1 and aprepitant + dexamethasone on Days 2 & 3.
Off dexamethasone treatment for ?4 weeks before the first dose of study drug.
No ongoing requirement for dexamethasone or anti-epileptic drugs.