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