Require systemic immunosuppressive therapies (eg, calcineurin inhibitors, methotrexate, mycophenolate, rapamycin, thalidomide, immunosuppressive antibodies such as anti-IL-6 or anti-IL-6 receptor [IL-6R])
Any condition requiring concurrent systemic immunosuppressive therapy
Chronic immunosuppressive therapy
Chronic immunosuppressive therapy
Chronic treatment with corticosteroids or other immunosuppressive therapy
Chronic treatment with corticosteroids or other immunosuppressive agents
Patients who have concurrent conditions resulting in immune compromise, including chronic treatment with corticosteroids or other immunosuppressive agents
Chronic systemic therapy with immunosuppressive agents including corticosteroids.
Ongoing immunosuppressive therapy.
Ongoing immunosuppressive therapy, including systemic or enteric corticosteroids
Ongoing treatment with steroid therapy or other immunosuppressive
Receiving immunosuppressive therapy including chronic steroids (except physiologic maintenance doses), methotrexate, or other known immunosuppressive agents
Ongoing treatment with immunosuppressive drugs
Regular immunosuppressive therapy
TREATMENT WITH SJCAR19: Receiving systemic immunosuppressive therapy in the 14 days prior to CAR T-cell infusion
Systemic therapy with immunosuppressive agents within 7 days before enrollment
Ongoing immunosuppressive treatment at the time of the start of voruciclib therapy, including systemic or enteric corticosteroids except as follows:
Ongoing immunosuppressive therapy other than corticosteroids.
Receiving immunosuppressive therapy
Patients currently treated with systemic immunosuppressive agents, including steroids, are ineligible until 3 weeks after removal from immunosuppressive treatment
A requirement for systemic immunosuppressive therapy for any reason
Patients receiving concomitant immunosuppressive agents for medical condition
Significant active infection or immune deficiency (including chronic use of immunosuppressive drugs)
Patients requiring chronic systemic immunosuppressive medication including pharmacologic dose of glucocorticoids or cyclosporine should be evaluated by the Medical Monitor for enrollment eligibility.
Patients must not have a history of the following immunosuppressive conditions: bone marrow transplantation and/or organ transplants and/or chronic rheumatic conditions that require active immunosuppressive therapy; patients with a history of chronic lymphoid or leukemic malignancies which are not under active therapy (no active therapy within the last 3 months) will be eligible; patients with chronic lymphoid or leukemic malignancies are eligible with or without active disease as long as they have not had treatment within the past three months
Has a history of the following immunosuppressive conditions: bone marrow transplantation, and/or organ transplants and/or chronic rheumatic conditions that require active immunosuppressive therapy; patients with chronic lymphoid/leukemic malignancies that have undergone treatment in the last 3 months will be ineligible
Conditions requiring chronic steroid or immunosuppressive treatment that likely need additional steroid or immunosuppressive treatments in addition to the protocol therapy
Patients must not be receiving active immunosuppressive therapy.
Chronic treatment with corticosteroids or other immunosuppressive agents
Patients on immunosuppressive agents
Receiving immunosuppressive therapy including chronic steroids, methotrexate, or other known immunosuppressive agents
Patients on or requiring immunosuppressive therapies
Patients currently treated with systemic immunosuppressive agents, including steroids, are ineligible until 3 weeks after removal from immunosuppressive treatment
Patients who are receiving cyclosporine, tacrolimus, or other chronic immunosuppressive agents are NOT eligible for participation
Administration of immunosuppressive drugs less than 2 weeks prior to first dose of ERC1671
Systemic immunosuppressive therapy in the past 14 days
Increasing or chronic treatment (> 5 days) with corticosteroids or another immunosuppressive agent
Under active treatment with immunosuppressive agents such as systemic corticosteroids or cyclosporine that cannot be discontinued before starting rRp450 infusions
Patients must not be receiving active immunosuppressive therapy.
received immunosuppressive therapy < 3 months prior to study Day 1
Systemic cytotoxic or immunosuppressive therapy to be administered concomitantly while participating on this study;
Need for ongoing treatment with an immunosuppressive agent
Is currently treated with systemic immunosuppressive agents, including steroids, are ineligible until 3 weeks after removal from immunosuppressive treatment
Chronic treatment with corticosteroids or other immunosuppressive agents
Patients on chronic steroid use or other immunosuppressive agents
Immunosuppressive therapy within 30 days prior to initiation of protocol therapy
Immunosuppressive therapy within 30 days prior to initiation of protocol therapy
Has a diagnosis of immunosuppressive disorder OR is on any other form of immunosuppressive therapy within 7 days prior to transplant admission
Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent
Any heart or lung transplant patient on immunosuppressive agents; renal transplant patients are allowed if patient is willing to reduce immunosuppressive agents and understand risk of rejection and possible need to return to dialysis; patients with chronic lymphocytic leukemia (CLL) or other hematologic malignancies are allowed
Patients who require systemic corticosteroid or other immunosuppressive therapy; immunosuppressive therapy must be stopped at least 14 days prior to cell infusion
A requirement for systemic immunosuppressive therapy for any reason
Patients needing chronic, immunosuppressive systemic steroids are excluded
Patients needing chronic, immunosuppressive systemic steroids are excluded
Systemic immunosuppressive therapy for any reason
Active systemic immunosuppressive therapy
Concurrent immunosuppressive therapy and no known immunosuppressive disease other than primary tumour
Ongoing immunosuppressive therapy
Ongoing systemic immunosuppressive therapy other than corticosteroids.
Patients on immunosuppressive therapy including systemic corticosteroids.
Receiving immunosuppressive therapy
Immunosuppressive therapy
Use of systemic immunosuppressive drugs
Patients receiving chronic treatment with systemic steroids or another immunosuppressive agent.
Patients with known immunodeficiency or receiving immunosuppressive therapies
Use of immunosuppressive therapy within 28 days of starting study treatment. Immunosuppressive therapy includes but is not limited to cyclosporine A, tacrolimus, or high-dose corticosteroids. Subjects receiving corticosteroids must be at a dose level ? 10 mg/day within 7 days of initiating study treatment.
Patients on immunosuppressive therapy including:
Any condition requiring concurrent systemic immunosuppressive therapy
Immunosuppressive disease
Any condition requiring active steroid or other immunosuppressive therapy
Chronic immunosuppressive therapies, including systemic corticosteroids
No concurrent condition resulting in immune compromise, including chronic treatment with corticosteroids or other immunosuppressive agents
Current, active immunosuppressive therapy such as cyclosporine, tacrolimus, etc.
A requirement for chronic systemic immunosuppressive therapy for any reason
Concurrent condition resulting in immune compromise, including chronic treatment with corticosteroids or other immunosuppressive agents
History of organ transplant, or current active immunosuppressive therapy (such as cyclosporine, tacrolimus, etc.).
Receiving ongoing treatment with immunosuppressive drugs, excluding those patients requiring dexamethasone for treatment of tumor-related edema
Immunosuppressive agents (unless required for treating potential AEs)
Receiving ongoing treatment with immunosuppressive drugs, excluding those patients requiring dexamethasone for treatment of tumor-related edema
Patients requiring chronic immunosuppressive therapy (including corticosteroids) for any medical condition
Chronic treatment with systemic steroids or another immunosuppressive agent
Require concurrent treatment with immunosuppressive agents (other than corticosteroids prescribed for a short course of therapy)
Ongoing systemic immunosuppressive therapy other than corticosteroids
Subjects requiring chronic use of immunosuppressive agents (eg, methotrexate, cyclosporine, corticosteroids)
Ongoing immunosuppressive therapy within 14 days prior to the start of study therapy;
Ongoing immunosuppressive therapy other than corticosteroids
Active treatment with corticosteroids or other immunosuppressive agents
Current, active immunosuppressive therapy such as cyclosporine, tacrolimus, etc.
Ongoing immunosuppressive therapy other than corticosteroids
Patient requires chronic use of immunosuppressive agents (e.g. methotrexate, cyclosporine)
Patients must not require chronic use of immunosuppressive agents (e.g. methotrexate, cyclosporine)
Receiving immunosuppressive drugs
Patients requiring continuous, systemic immunosuppressive therapy
Chronic treatment with systemic steroids or another immunosuppressive agent
Need for ongoing treatment with an immunosuppressive agent.
Patients receiving steroids or immunosuppressive therapy for the improvement of hematological parameters (stable steroid treatment for adrenal failure or chronic medical conditions, and intermittent dexamethasone as antiemetics are allowed).
Patients currently treated with systemic immunosuppressive agents, including steroids, are ineligible until 3 weeks after removal from immunosuppressive treatment
Clinically uncontrolled autoimmune disorders, transplant recipients who depend on immunosuppressive therapy, other immunosuppressive conditions including any concurrent condition requiring immunosuppressive/immunomodulating agents;
Use of any systemic immunosuppressive agents
No immunosuppressive therapy within 30 days prior to initiation of protocol therapy
On immunosuppressive therapy.
Increasing or chronic treatment (> 5 days) with corticosteroids or another immunosuppressive agent
Receiving immunosuppressive therapy
Patient is currently receiving increasing or chronic treatment with corticosteroids or another immunosuppressive agent
Subjects on steroid therapy or other immunosuppressive, such as azathioprine or cyclosporin A
Subjects with conditions requiring chronic steroid or immunosuppressive treatment
Chronic treatment with systemic steroids or another immunosuppressive agent
Immunosuppressive therapy within the last 3 months
The patient requires concomitant chronic treatment (more than 7 consecutive days) with systemic corticosteroids or any other immunosuppressive agents.
Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent
Subjects with immunosuppressive disease that require use of systemic steroids or immunosuppressive treatment
Patients on chronic immunosuppressive medications, including steroids, within the past three months
Has a diagnosis of an immunosuppressive illness or a condition requiring chronic immunosuppression
Receiving immunosuppressive therapy including chronic steroids, methotrexate, or other known immunosuppressive agents
Need for chronic immunosuppressive drugs
Need for chronic immunosuppressive drugs
Patients who take immunosuppressive medication, i.e. steroid therapy or other immunosuppressive/immunomodulating drugs (e.g. Cyclosporine) within 2 months prior to first study drug injection
Is taking immunosuppressive therapy
Chronic immunosuppressive therapy within 30 days of screening
Patients who have chronic immunosuppression or are on current immunosuppressive therapies
Confirmed or suspected immunosuppressive or immunodeficient condition
Receiving immunosuppressive therapy to include chemotherapy, steroids, or methotrexate
Are immunosuppressed or in chronic use of immunosuppressive drugs.
Subjects on chronic steroid therapy, other immunosuppressive therapy
ongoing chronic immunosuppressive therapy
The participant is receiving therapy with immunosuppressive agents.
The participant is receiving therapy with immunosuppressive agents.
Patients requiring daily systemic corticosteroids are not eligible; patients must not have received systemic corticosteroids within 7 days prior to enrollment; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid; Note: use of topical or inhaled corticosteroids will not render a patient ineligible
Has received more than 2 days of systemic corticosteroids for aGVHD.
Patients on any systemic corticosteroid therapy within one week before the planned date for first dose on study would not be eligible; exception: patients on physiologic replacement doses of corticosteroids are permitted
Any condition that would prohibit administration of corticosteroids
Conditions that would prohibit administration of corticosteroids
Patients must not have received any immunosuppressive medication within 28 days prior to sub-study registration and must not be planning to receive these medications while on protocol therapy; systemic corticosteroids must be stopped at least 24 hours prior to sub-study registration; however, intranasal and inhaled corticosteroids are allowed at any time before and during protocol therapy
NO patients receiving systemic corticosteroids (either intravenous [IV] or oral steroids, excluding inhalers or low-dose hormone replacement therapy) within 1 week before administration of the first dose of study drug
Patients receiving chronic pharmacologic doses of corticosteroids are not eligible; for the purposes of eligibility, chronic exposure is defined as anticipated exposure of > 3 weeks, including the sum of both pre-enrollment and anticipated post-enrollment dosing; patients on acute corticosteroid therapy (=< 3 weeks of total planned exposure) must still meet the normal blood glucose requirement; patients receiving chronic inhaled corticosteroids or chronic physiologic replacement doses of corticosteroids are eligible
It is preferred, but not required, that corticosteroids and hydroxyurea should start only after all diagnostic samples have been obtained; however, if the patient was previously on corticosteroids and/or hydroxyurea, this is allowable provided that the patient still has measurable disease at time of the bone marrow aspirate\r\n* Corticosteroids and/or hydroxyurea, as well as any of the other therapies mentioned (with the exception of IV cyclophosphamide), may continue to be administered, at physician discretion, until 1 day prior to blinatumomab administration\r\n** IV cyclophosphamide must be discontinued at least 7 days prior to blinatumomab administration
Treatment with systemic immune modulators including, but not limited to, non-topical systemic corticosteroids, cyclosporine, and tacrolimus within 2 weeks before enrollment (day 1).
Patients receiving systemic corticosteroids (patients off steroids for at least 48 hours are eligible)
Patients must not be receiving chronic systemic corticosteroids at doses greater than physiologic dosing (inhaled corticosteroids acceptable).
Are receiving increasing doses of corticosteroids
Patients must have no clinical evidence of leptomeningeal or brain metastasis causing spinal cord compression that are symptomatic or untreated or not stable for >= 3 months (must be documented by imaging) or requiring corticosteroids; subjects on a stable dose of corticosteroids > 1 month or who have been off of corticosteroids for at least 2 weeks can be enrolled with approval of the Cancer Therapy Evaluation Program (CTEP) medical monitor; subjects must also be off of enzyme-inducing anticonvulsants for > 4 weeks
Use of corticosteroids (glucocorticoids) within 21 days of the MILs collection
TREATMENT: Patients receiving systemic corticosteroids
Patients must have previously untreated disease (except for one week or less of corticosteroids)
Received corticosteroids within the past 1 week
Patients receiving systemic corticosteroids (patients off steroids for at least 48 hours are eligible)
Patients receiving corticosteroids are eligible for this trial
Participants who have received 2 or more systemic treatment for cGvHD in addition to corticosteroids ± CNI for cGvHD
Patients that transition from active aGvHD to cGvHD without tapering off corticosteroids ± CNI and any systemic treatment * Patients receiving up to 30 mg by mouth once a day of hydrocortisone (i.e., physiologic replacement dose) of corticosteroids are allowed.
Patients receiving systemic corticosteroids (either IV or oral steroids, excluding inhalers or low-dose hormone replacement therapy) within 1 week before administration of the first dose of the study drugs.
No history of long-term use of corticosteroids or concurrent short term use of corticosteroids is allowed
Subjects, who have received previous systemic corticosteroids treatment or poorly absorbable corticosteroids for the treatment of aGVHD, for longer than 3 days (72 hours).
Subject who used corticosteroids (excluding inhalers, eye-drops, and dermatologic corticosteroids) within 6 weeks prior to surgery;
Patients may not be on immunosuppressive therapy, including corticosteroids (with the exception of physiologic replacement, defined as 0.75 mg/m^2/day) at time of enrollment; however, patients who require intermittent use of bronchodilators or local steroid injections will not be excluded from the study
Patient is receiving unstable or increasing doses of corticosteroids.
Systemic corticosteroids are permissible in the following circumstances:\r\n* 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\r\n* Ongoing administration of a stable dose of corticosteroid therapy (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 receiving systemic corticosteroids (patients off steroids for at least 48 hours are eligible)
Chronic use of immune-suppressive drugs (ie, systemic corticosteroids used in the management of cancer or non-cancer related illnesses, eg, COPD).
No systemic corticosteroids (unless physiologic replacement dosing) within 7 days of enrollment
Patients who have received high doses of systemic corticosteroids for the treatment of their ATL within 4 weeks prior to the start of therapy
Concurrent systemic treatment or prior therapy within 4 weeks for SMM; NOTE: Treatment with corticosteroids for other indications is permitted
Use of corticosteroids or other immunosuppression (if patient had been taking steroids, at least 2 weeks must have passed since the last dose)
Patients receiving systemic corticosteroids greater than 2-weeks in duration within 6 months of study entry must have evidence of adequate adrenal function based upon morning plasma cortisol concentration or ACTH (cosyntropin) stimulation test
Patients receiving systemic corticosteroids (either IV or oral steroids, excluding inhalers or low-dose hormone replacement therapy) within 1 week before administration of the first dose of study drug.
Need for systemic treatment with corticosteroids for cGVHD
Received any previous systemic treatment for cGVHD with the exception of corticosteroids administered for cGVHD within the 72 hours prior to signing the informed consent form.
Corticosteroids
Concurrent systemic corticosteroids, cytokines, and immunomodulatory therapy (e.g. interferons)
Patients receiving concurrent corticosteroids at the time protocol therapy is initiated other than for physiologic maintenance treatment
No systemic corticosteroids (unless physiologic replacement dosing) within 7 days of enrollment
Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids
No systemic corticosteroids (unless physiologic replacement dosing) within 7 days of enrollment
Patients who are receiving systemic corticosteroids
Off all but replacement dose of corticosteroids from Day -7 to Day 28 (replacement dose is the patient's individualized dose defined for physiological replacement).
Use of systemic corticosteroids
Off all but replacement dose of corticosteroids from Day -7 to Day 28 (replacement dose is the patient's individualized dose defined for physiological replacement).
Chronically treated with systemic doses of immunosuppressive drugs such as cyclosporin, ACTH, or corticosteroids.
Any condition that requires the use of corticosteroids outside of corticosteroids defined in the protocol after day 1 of therapy
Patients who are on corticosteroids or immunosuppressant’s are not eligible; a 2 week wash-out period for is required before registration
Patients who have received systemic corticosteroids within 28 days prior to the first dose of study drug
1% prednisolone acetate ophthalmic suspension and any other corticosteroids.
Patients receiving corticosteroids (either IV or oral steroids, excluding inhalers or low-dose hormone replacement therapy) within 1 week before administration of the first dose of study drug
Patients receiving systemic corticosteroids (either intravenous [IV] or oral steroids, excluding inhalers or low-dose hormone replacement therapy) within 1 week before administration of the first dose of study drug
Subjects requiring daily corticosteroids either via oral route of administration (po) or infusion.
Patient has history of primary immunodeficiency OR has received any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment, excluding intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses; attempts should be made to have patient on lowest possible dose of steroids (acceptable range 4-10 mg, please contact PI if dose is > 4 mg) and weaned to off as is feasible
Patients receiving systemic corticosteroids (either IV or oral steroids, excluding inhalers or low-dose hormone replacement therapy) within 1 week before administration of the first dose of study drug
Any concurrent treatment that would compromise the study including but not limited to continuous high dose corticosteroids (>0.5mg/kg), lymphodepleting antibodies or cytotoxic agents.
Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids
Patients receiving systemic corticosteroids (either IV or oral steroids, excluding inhalers or low-dose hormone replacement therapy) within 1 week before administration of the first dose of study drug
Subject requires or is likely to require more than a two-week course of corticosteroids for intercurrent illness; subject must complete the course of corticosteroids 2 weeks before screening to meet eligibility
Patients being chronically treated with immunosuppressive drugs such as cyclosporin, adrenocorticotropic hormone (ACTH), or systemic corticosteroids
Conditions that would prohibit administration of corticosteroids
No systemic corticosteroids (unless physiologic replacement dosing) within 7 days of enrollment
Any condition that requires or is likely to require treatment with systemic corticosteroids within the core study period and short term follow-up
Subjects who require or are likely to require more than a two-week course of corticosteroids for intercurrent illness; subjects must complete therapy prior to enrollment; topical corticosteroids should be stopped at least 2 weeks prior to enrollment and systemic corticosteroids should be stopped at least 4 weeks prior to enrollment
Conditions that would prohibit intermittent administration of corticosteroids for T-DM1 premedication.
Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids, such as systemic cyclosporine and tacrilomus; consult principal investigator for questions, including necessary washout period for the specific drug
Patients must have no clinical evidence of leptomeningeal or brain metastasis causing spinal cord compression that are symptomatic or untreated or not stable for >= 4 weeks (must be documented by imaging) or requiring corticosteroids; subjects on a stable dose of corticosteroids > 1 month or who have been off of corticosteroids for at least 2 weeks can be enrolled with approval of the Cancer Therapy Evaluation Program (CTEP) medical monitor; subjects must also be off of enzyme-inducing anticonvulsants for > 4 weeks
Treatment with corticosteroids within 4 weeks prior to enrollment
Patients taking systemic corticosteroids
Fixed or decreasing dose of corticosteroids (or no corticosteroids) for at least 1 week prior to cycle 1 day 1
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 3 days without recurrence of symptoms prior to starting trial therapy; corticosteroids for other indications is allowed
Current use of systemic corticosteroids
More than 4 weeks since prior systemic corticosteroids
Corticosteroids by aerosol are allowed
Patients who have received systemic chemotherapy (corticosteroids not included) less than 3 weeks prior to the start of this protocol
Any therapy =< 2 weeks prior to registration; NOTE: Exception: patients on ibrutinib or corticosteroids (any dose) may continue therapy up until the new regimen has started at investigator discretion; corticosteroids can be tapered to lowest possible dose after start of treatment at investigator discretion
Patients receiving unstable or increasing doses of corticosteroids
Patients must have discontinued systemic antineoplastic therapy (including endocrine and biological agents, as well as systemic corticosteroids) at least three (3) to four (4) weeks prior to enrollment. Toxicities from previous therapies must be grade 1 or less.
Neurological symptoms related to underlying disease requiring increasing doses of corticosteroids
Patient received corticosteroids within 2 weeks prior to the first dose.
At least 2 weeks beyond corticosteroids.
Patients who have received corticosteroids =< 2 weeks prior to starting study drug; the exception is patients receiving low dose steroids for CNS disease; otherwise, systemic corticosteroids should not be administered with BKM120
Immunosuppression (corticosteroids to prevent brain edema are permitted)
ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Daily administration of systemic immunosuppressive therapy or corticosteroids (except in physiological doses for hormone deficiency) during the previous 30 days
Any use of systemic corticosteroids within 10 days of treatment initiation.
Patients must not be receiving chronic systemic corticosteroids at doses greater than physiologic dosing (inhaled corticosteroids acceptable).
Patients requiring systemic corticosteroids (unless patients have had no corticosteroids within 4 weeks prior to start of study)
Subjects require or are likely to require more than a 2-week course of corticosteroids for intercurrent illness. Subjects must have completed the course of corticosteroids at the time of apheresis to meet eligibility.
No prior therapy is allowed except for the following:\r\n* Short courses of corticosteroid (defined as =< 7 days of corticosteroids within the 4-weeks preceding registration) are allowed\r\n** Participants who have been on corticosteroids chronically (defined as more than 7 days of corticosteroids within the 4-weeks preceding registration or more than 28 days of corticosteroids over the preceding 6 months) are not eligible; previous courses of inhaled corticosteroids of any duration are allowed\r\n* A single dose of intrathecal cytarabine (at the time of the diagnostic lumbar puncture) is allowed prior to registration; if patient has received intrathecal (IT) cytarabine prior to informed consent for protocol treatment, day 1 IT cytarabine should not be administered\r\n* Emergent radiation to the mediastinum or other life-threatening masses is allowed prior to registration
The subject requires or is likely to require more than a 2-week course of corticosteroids of > 4 mg
Treatment with systemic corticosteroids within 2 weeks prior to the start of the treatment; patients that require inhaled or low-dose corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, mineralocorticoids are allowed
Patients who are currently receiving or plan to receive corticosteroids except as described below \r\n* Systemic corticosteroids may be administered for cytoreduction up to 24 hours prior to the start of protocol therapy, as a premedication for InO and as treatment for allergic reactions or for physiologic replacement/stress dosing of hydrocortisone for documented adrenal insufficiency; corticosteroids are not allowed for other indications
No oral corticosteroids 3 days before initiating combinations TEW-7197/POM; inhaled corticosteroids are permitted
Has had systemic corticosteroids within 2 weeks of the first dose of protocol-related radiation or MK-3475
Leptomeningeal or brain metastases or metastases causing spinal cord compression that are symptomatic or untreated or not stable for >= 3 months (must be documented by imaging) or requiring corticosteroids; subjects on a stable dose of corticosteroids > 1 month or who have been off of corticosteroids for at least 2 weeks can be enrolled with approval of the Cancer Therapy Evaluation Program (CTEP) medical monitor; subjects must also be off of enzyme-inducing anticonvulsants for > 4 weeks
No prior therapy is allowed except for the following:\r\n* Corticosteroids: short courses of corticosteroid (defined as =< 7 days of corticosteroids within the 4 weeks preceding registration) are allowed prior to registration; note: if patient has received pre-treatment with corticosteroids, they should not receive steroid prophase\r\n** Participants who have been on corticosteroids chronically (defined as more than 7 days of corticosteroids within the 4 weeks preceding registration or more than 28 days of corticosteroids over the preceding 6 months) are not eligible\r\n* IT cytarabine: a single dose of intrathecal cytarabine (at the time of the diagnostic lumbar puncture) is allowed prior to registration; if patient has received IT cytarabine prior to registration, day 1 IT cytarabine should not be administered\r\n* Emergent radiation therapy: emergent radiation to the mediastinum or other life-threatening masses is allowed prior to registration
Participants who have received more than 7 days of corticosteroids in the preceding 4 weeks or more than 28 days of corticosteroids in the preceding 6 months are not eligible
Corticosteroids should not be used during chemotherapy administration as an antiemetic
Any condition that would prohibit administration of corticosteroids
Patient must have received no prior radiation therapy or chemotherapy other than corticosteroids; corticosteroids are allowable for all patients
Any use of systemic corticosteroids in the prior 4 weeks
Patients requiring treatment with corticosteroids are eligible
Patients receiving chronically dosed corticosteroids within 7 days prior to enrollment are not eligible for this trial
Conditions that would prohibit administration of corticosteroids
Patients taking systemic corticosteroids
Subjects who cannot tolerate a corticosteroid taper, that is, begin corticosteroids at 2.0 mg/kg per day, demonstrate response, but progress before a 50% decrease from the initial starting dose of corticosteroids is achieved.
Concurrent, recent (? 4 weeks ago) or anticipated treatment with systemic corticosteroids at any dose, or
Requiring corticosteroids or anticonvulsants in the prior 60 days
Concurrent, recent (? 4 weeks ago) or anticipated treatment with systemic corticosteroids at any dose, or
Requiring corticosteroids or anticonvulsants in the prior 60 days
Have had any chemotherapy or systemic corticosteroids within 2 weeks of study entry.
Concurrent, recent (? 4 weeks ago) or anticipated treatment with systemic corticosteroids at any dose, or
Daily administration of systemic immunosuppressive therapy or corticosteroids (except in physiological doses for hormone deficiency) during the previous 30 days.
Systemic (oral or parenteral) corticosteroids within 14 days of study entry
Current use of systemic corticosteroids
Patients receiving corticosteroids are not eligible; patients must have been off corticosteroids for 7 days prior to start of chemotherapy
Concurrent or planned concurrent treatment with systemic high dose (immunosuppressive) corticosteroids or treatment with systemic corticosteroids within 4 weeks of baseline
Patients who have received oral or parenteral corticosteroids within 2 weeks of study entry or who have a clinical requirement for ongoing systemic immunosuppressive therapy not related to chemotherapy administration.
Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids
Systemic corticosteroids use =< 2 weeks, regardless of indication; note: patients who are on inhaled corticosteroids are eligible
Patients receiving concurrent corticosteroids for reason(s) other than for physiologic maintenance treatment; patients should otherwise discontinue corticosteroids prior to registration to study
Concurrent maintenance corticosteroids;
No previous use of corticosteroids for autoimmune complications that have developed since the initial diagnosis of CLL; prior use of corticosteroids for reasons other than treatment of autoimmune complications is allowed
History of long-term use of corticosteroids or concurrent short-term use of corticosteroids is not allowed; short-term corticosteroid use must be discontinued at least 2 weeks prior to study treatment
Brain metastases that are symptomatic or untreated or not stable for >= 3 months (must be documented by imaging) or requiring corticosteroids; subjects on a stable dose of corticosteroids > 1 month or who have been off corticosteroids for at least 2 weeks can be enrolled with approval of the Cancer Therapy Evaluation Program (CTEP) medical monitor; subjects must also be off enzyme-inducing anticonvulsants for > 4 weeks
Treatment with corticosteroids within 2 weeks
Clinically stable and off corticosteroids for at least 4 weeks prior to study enrollment
Patients receiving immunosuppressive treatment as well as corticosteroids which cannot be discontinued at least 4 weeks before dosing.
Chronic use of corticosteroids
Currently being treated with bronchodilators or corticosteroids
Past or current anti-cancer treatment except corticosteroids during less than one week.
Long-term use of systemic corticosteroids
Patients receiving oral corticosteroids within 30 days of enrollment.
For Dose Confirmation (Parts B, D, E, F and G): Have CNS metastasis that is radiographically or clinically unstable less than 14 days prior to receiving study drug, regardless of whether they are receiving corticosteroids
For Dose Confirmation (Part C): Have glioblastoma multiforme that is radiographically or clinically unstable less than 14 days prior to receiving study drug, regardless of whether they are receiving corticosteroids
Patients who have been treated for at least two weeks with stable doses of corticosteroids to address conditions unrelated to their malignancy will be allowed to continue this treatment during enrollment on the current trial
Concurrent treatment with corticosteroids. If they are already on steroids, patients will be allowed to enroll on the study but will need to taper off as soon as possible.
Subject requires or is likely to require more than a two week course of corticosteroids for intercurrent illness; subject must complete the course of corticosteroids 2 weeks before screening to meet eligibility
Supraphysiologic doses of corticosteroids within 3 weeks
Patients who have received systemic chemotherapy (corticosteroids not included) less than 3 weeks prior to the start of this protocol
Subjects with a medical condition requiring chronic systemic corticosteroids
Any other disease requiring long-term corticosteroids or immunosuppressants
Patients must not be receiving chronic systemic corticosteroids at doses greater than physiologic dosing (inhaled corticosteroids acceptable).
Subjects must be receiving systemic corticosteroids.
Participants must be receiving systemic corticosteroids. Treatment with methylprednisolone/systemic steroids must have been initiated within 72 hours prior to the first dose of study treatment after enrollment
Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids, such as systemic cyclosporine and tacrolimus
No ongoing requirement for corticosteroids
Daily requirement for corticosteroids (except for inhalation corticosteroids).
Is receiving chronic corticosteroids administered at doses greater than those used for normal replacement therapy
Is taking systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication
Patient has discontinued all corticosteroids for that indication for at least 2 weeks;
Patients who require treatment with systemic corticosteroids for serious medical conditions or illnesses (e.g. immunosuppression after organ transplantation)
Patients currently receiving systemic corticosteroids
Patients on systemic corticosteroids (except for patients on stable doses of hormone replacement therapy such as hydrocortisone), or other immunosuppressants (e.g., infliximab, mycophenolate mofetil) are excluded
For patients on corticosteroids, they must have been on a fixed dose for 1 week prior to entry if clinically recommended
Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids
Patients on corticosteroids for any reason
Patients who have received systemic corticosteroids =< 2 weeks prior to starting study drug; systemic corticosteroids should not be administered with BKM120 (usage of steroids as premedications and anti-emetics for paclitaxel and carboplatin, per MSKCC guidelines, is allowed; steroids given as part of pre-medications for imaging studies are not exclusionary)
Patients taking systemic corticosteroids
patients receiving hydroxyurea or corticosteroids that has not been discontinued at least 1 week after initiation of nilotinib
Prior corticosteroids allowed
Patients must not require use of systemic corticosteroid within 14 days prior to registration or during protocol treatment; patients with preexisting severe autoimmune disease requiring systemic corticosteroids or ongoing immunosuppression are not eligible
Patients must not be receiving any of the following concomitant medications:\r\n* Pharmacologic doses of systemic corticosteroids unless for CNS metastatic or primary disease; for patients with CNS metastatic or primary tumors receiving corticosteroids, they should be on a stable or decreasing dose over the 7 days prior to registration; for all patients, receipt of systemic physiologic replacement steroids, topical, and/or inhaled corticosteroids is acceptable\r\n* Non-steroidal anti-inflammatory drugs, oral anticoagulants, and therapeutic heparins
Treatment with high dose systemic corticosteroids or continuous use of other immunosuppressants within the past 30 days
Current use of corticosteroids defined as oral, intravenous (IV), or injections of corticosteroids in the past 4 weeks\r\n* If the patient is only prescribed a short-term, time-limited dose of oral, intravenous (IV), or injections of corticosteroids, then they may be rescreened for eligibility once they are >= 4 weeks post-completion of their course of corticosteroids
Use of oral corticosteroids or topical corticosteroids in the irradiation area
Short course systemic corticosteroids is permissible for disease control, improvement of performance status or non-cancer indication if =< 10 days and must be discontinued prior to study treatment
Patients receiving systemic corticosteroids (either IV or oral steroids, excluding inhalers or low-dose hormone replacement therapy) within 1 week before administration of the first dose of study drug
Patients must not have received oral corticosteroids, intramuscular corticosteroids, or intra-articular steroids for joint symptoms within 28 days prior to registration
Treatment with high dose systemic corticosteroids or continuous use of other immunosuppressants within the past 6 months
Patients on chronic corticosteroids
Patients on systemic corticosteroids (oral or intravenous)
Treatment within 3 months with immunomodulatory therapy (e.g., interferons, immunoglobulin therapy, interleukin 1 receptor antagonist or systemic corticosteroids); short-term systemic corticosteroids or topical or intra-articular steroids are acceptable, at the discretion of the Investigator
Corticosteroids: no restrictions