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+Any corticosteroid therapy for indications other than GVHD at doses > 1 mg/kg per day methylprednisolone (or prednisone equivalent) within 7 days of randomization.
+The subject has received systemic dexamethasone continuously at a dose > 8 mg/day for 8 weeks prior to the date of the screening assessment
+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
+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
+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
+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
+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
+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
+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;
+Subjects requiring systemic steroid therapy should be receiving ? 10 mg/day of prednisone (or equivalent) for the 2 weeks preceding start of study.
+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)
+Any prior cumulative doxorubicin dose must be ? 360 mg/m2; prior cumulative epirubicin dose must be ? 720 mg/m2.
+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.
+Requires treatment with high dose systemic corticosteroids defined as dexamethasone > 2 mg/day or bioequivalent within at least 7 days of initiating therapy
+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.
+< 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
+Treatment with systemic corticosteroids >20 mg/day, prednisone or equivalent
+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)
+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.
+Requires treatment with high dose systemic corticosteroids defined as dexamethasone > 2 mg/day or bioequivalent within 7 days of initiating therapy
+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;
+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
+Patients requiring chronic high dose immunosuppressants including steroids (prednisone daily equivalent of >= 10 mg)
+Prior treated brain or meningeal metastases must be without evidence of progression (confirmed by MRI) for at least 8 weeks and off immunosuppressive doses of systemic steroids (greater than 10 mg/day prednisone or equivalent) for at least 4 weeks before study drug administration
+Daily requirement for corticosteroids (> 10 mg prednisone once daily [QD] or equivalent)
+Any prednisone (or equivalent corticosteroids) use within 2 weeks of study entry
+On chronic systemic steroid therapy (>10 mg/day prednisone or equivalent) within 2 weeks prior to first dose of study drug or on any other form of immunosuppressive medication
+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.
+Cumulative dose of doxorubicin or equivalent of > 360 mg/m^2 during prior adjuvant therapy
+Treatment with high dose systemic corticosteroids defined as dexamethasone > 2 mg/day or bioequivalent within 7 days of initiating therapy
+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 high dose systemic corticosteroids defined as dexamethasone > 2mg/day or bioequivalent within 7 days of initiating therapy
+Existing significant autoimmune conditions; patients with a history of Hashimoto thyroiditis who are stable on replacement hormone therapy are not excluded; patients cannot be on long-term (> 4 weeks) corticosteroids at doses exceeding prednisone 20 mg (or its equivalent) prior to enrollment; short-term corticosteroid dosing is permitted as long as steroids are discontinued within 2 weeks of study enrollment
+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).
+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.
+Received previous systemic chemotherapy with a cumulative dose of > 900 mg/m^2 of epirubicin or > 400 mg/m^2 of doxorubicin
+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.
+Subjects receiving prednisone or steroids must continue on the same dose they were receiving at the time of screening
+Is on chronic systemic steroid therapy in excess of replacement doses (prednisone ? 10 mg/day is acceptable), or on any other form of immunosuppressive medication. For CTCL, continued use of either prednisone ?10 mg/day or continued use of topical steroids is acceptable.
+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)
+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
+Any chronic medical condition requiring a higher dose of corticosteroid than equivalent of 5 mg prednisone/prednisolone once daily
+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)
+No requirement of > 0.5 mg/kg of prednisone (or equivalent) daily dose within 1 week of randomization
+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
+EXCLUSION - INFUSION: Current use of systemic corticosteroids > 0.5 mg/kg/day
+Concurrent systemic immunosuppressant therapy (e.g., cyclosporine A, tacrolimus, etc., or chronic administration [> 14 days] of > 20 mg/day of prednisone) within 28 days of the first dose of study drug
+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.
+Off or low dose (=< 4 mg/day by Decadron) corticosteroid for at least for 2 weeks before the first pre-surgical vaccine
+TREATMENT EXCLUSION: Current use of systemic corticosteroids at a dose equivalent to 0.5 mg/kg/day of prednisone or higher
+Immunosuppressive steroids within 3 months before first ZW25 dosing, except for chronic steroid doses of ?15 mg per day for adrenal insufficiency
+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
+Concurrent systemic immunosuppressant therapy (e.g., cyclosporine A, tacrolimus, etc., or chronic administration [> 14 days] of > 20 mg/day of prednisone) within 28 days of the first dose of study drug
+Patient receives chronic steroid use > 10 mg prednisone (or steroid equivalent) daily
+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
+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)
+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.
+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
+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.
+Patients requiring systemic steroid therapy or any immunosuppressive therapy (?10mg/day prednisone or equivalent) which cannot be discontinued at least 7 days prior to first dose of study treatment.
+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
+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)
+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
+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
+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
+Must be on =< 20 mg of oral daily prednisone or equivalent for GVHD
+Daily dexamethasone > 4 mg at the time of registration
+Current use of systemic corticosteroids > 0.5 mg/kg/day
+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
+Systemic corticosteroids greater than the equivalent of 10 mg of prednisone per day within 4 weeks of study drug administration are prohibited
+Currently taking corticosteroids (> 0.5 mg/kg/day prednisone or equivalent) for therapy of GVHD
+Systemic steroids that have not been stabilized to the equivalent of =< 10 mg/day prednisone prior to the start of the study drugs
+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
+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
+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
+History of any condition requiring anti-platelet therapy (aspirin > 300 mg/day, clopidogrel > 75 mg/day)
+Chemotherapy within 2 weeks of first dose of sEPHB4-HSA (minimum of 6 weeks for nitrosoureas and 8 weeks for bone marrow transplantation) with the following exceptions:\r\n* Hydroxyurea allowed prior to, and up to day +5 of cycle 0 of treatment (max 100 mg/kg/day)\r\n* Corticosteroids allowed until day -3 (max dexamethasone 20mg/day)\r\n* Maintenance chemotherapy for ALL allowed one week prior to start of treatment (e.g., POMP)
+Corticosteroids use exceeding a cumulative dose of 160 mg of dexamethasone during screening
+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
+Patients that require decadron > 4 mg/ day or equivalent of steroids.
+Chronic steroid therapy, however prednisone or its equivalent is allowed at =< 10 mg/day.
+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
+The subject is off corticosteroids of > 10 mg/day prednisone or equivalent.
+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)
+Patients receiving prednisone > 0.1 mg/kg/day or equivalent at time of enrollment, or who have received anti- thymocyte globulin (ATG) within 14 days or have received donor lymphocyte infusion (DLI) or Campath within 28 days of enrollment.
+Steroid doses greater than an equivalent of prednisone 10 mg daily
+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
+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
+Subjects with immunotherapy related adverse events requiring high doses of steroids (? 40 mg/day of prednisone) are not eligible.
+Inability to begin a prednisone dose ?0.5 mg/kg/d for the treatment of cGVHD
+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
+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
+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)
+Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (> 10 mg prednisone daily or equivalent) or any other form of immunosuppressive therapy prior to trial treatment; patients receiving systemic steroids at physiologic doses are permitted to enroll assuming steroid dose is not above the acceptable threshold (> 10 mg prednisone daily or equivalent)
+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.
+Prior anthracycline cumulative dose below 550 mg/m2 or the daunorubicin equivalent which is the recommended non-cardiotoxic level.
+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 with evidence of clinically significant immunosuppression such as the following are ineligible:\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
+Patients on corticosteroids > 0.1 mg/Kg/day (i.e. > the maximum dose of 4mg/day)
+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
+Concomitant use of systemic corticosteroids at physiologic doses or > 10 mg/day of prednisone or equivalent
+At least 2 weeks (or 5 half-lives, whichever is longer) wash-out since the end of previously administered experimental therapy (6 weeks if previous nitrosourea containing regimen) or 2 weeks for standard-of-care regimens. Concurrent corticosteroids are allowed provided they are administered at an equivalent prednisone dose of ? 10 mg/day, as prediction or blood products only;
+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
+Need for current chronic corticosteroid therapy (>= 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids)
+Requirement for corticosteroids greater than the equivalent of 10 mg of prednisone daily for more than 2 weeks.
+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
+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 must have no clinical evidence of leptomeningeal or brain metastasis causing spinal cord compression that are symptomatic, untreated, not stable for >= 4 weeks prior to day 1 of cycle 1 (must be documented by imaging), or requiring corticosteroids to manage metastasis-related symptoms. Subjects who have been off of corticosteroids for at least 2 weeks prior to day 1 of cycle 1 or are on a stable dose of =< 10 mg per day of a prednisone equivalent for > 1 month prior to day 1 of cycle 1 can be enrolled. Subjects must also be off of enzyme-inducing anticonvulsants for > 4 weeks prior to day 1 of cycle 1.
+Dexamethasone dose =< 4 mg daily
+Subjects who are currently using more than 5mg/day of prednisone (or an equivalent glucocorticoid exceeding physiologic replacement levels)
+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.
+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
+Be taking prednisone at a dose of =< 10 mg/day, 7 days prior to starting treatment (cycle 1 day 1[(C1D1])
+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)
+Known significant immunodeficiency due to underlying illness (e.g. HIV/acquired immunodeficiency syndrome [AIDS]) and/or immune-suppressive medication including high-dose corticosteroids (defined as >= 20 mg/day prednisone or equivalent which is ongoing at the time of enrollment and/or was taken for more than 4 weeks within the preceding 2 months of enrollment)
+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).
+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
+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).
+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
+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
+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
+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
+Receiving corticosteroids at > 20 mg (age > 17) or > 0.5 mg/kg (age < 18) daily prednisone dose or equivalent.
+Evidence of clinically significant immunosuppression such as the following:\r\n* Primary immunodeficiency state such as severe combined immunodeficiency disease\r\n* HIV positive \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\r\n* Concurrent opportunistic infection
+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 7 days prior to enrollment; however, in the setting of non-immune mediated indications for use, chronic/active low dose steroid use may be permitted at the discretion of the principal investigator
+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 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
+Concurrent systemic immunosuppressant therapy (eg, cyclosporine A, tacrolimus, etc, or chronic administration [> 14 days] of > 20 mg/day of prednisone) within 28 days of the first dose of study drug
+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 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
+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
+Corticosteroid use >30 mg/day of prednisone or equivalent, for purposes other than lymphoma symptom control
+Subjects requiring escalating or chronic supraphysiologic doses of corticosteroids (> 10 mg/d of prednisone equivalent) for control of disease at the time of registration
+At least 2 weeks beyond high dose systemic corticosteroids (however, low dose corticosteroids < 20 mg prednisone or equivalent daily are permitted).
+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.
+Daily corticosteroid requirement within 2 weeks of Cycle 1 Day 1
+Prednisone dose =< 5 mg/day and off all other systemic immunosuppressive medications for at least 4 weeks prior to study entry
+Corticosteroid therapy (>10 mg prednisone/day or equivalent) within 1 week prior to the first dose of study drug
+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
+Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of REGN2810
+Dexamethasone dose should be =< 4 mg/day or steroid equivalent prior to starting treatment; if higher doses are needed, consult with study chair
+CELL PROCUREMENT: Subjects currently receiving “maintenance” doses of chemotherapy are eligible and the need for intrathecal prophylaxis prior to procurement is left to the discretion of the investigator; maintenance doses of chemotherapy are defined as methotrexate =< 30 mg/m^2/week, mercaptopurine =< 100 mg/m^2/day and vincristine =< 2 mg/28 days; corticosteroid-containing maintenance therapy is permitted only if corticosteroids are administered > 14 days prior to procurement; (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)
+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
+Patients who have had prior everolimus but were not able to tolerate a 10 mg daily dose
+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
+Chronic use of corticosteroids in excess of prednisone 30 mg/day or its equivalent
+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
+Patients should not have any uncontrolled illness including ongoing or active infection; patients with an ongoing prednisone requirement of > 1 mg/kg/day (or equivalent) will be excluded
+Patients requiring chronic systemic immunosuppressants, including steroids (prednisone daily equivalent of >10 mg).
+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.
+Patients on greater than 4 mg per day of dexamethasone within the 2 weeks prior to admission for PVSRIPO infusion
+Administration of or condition requiring administration of systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to initiating study treatment; Exception: patients with conditions that can be managed with steroids equivalent to or less than an oral prednisone dose of 10 mg daily would not be excluded from the study
+Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of BI 754091
+Concurrent systemic immunosuppressant therapy (eg, cyclosporine A, tacrolimus, etc); any use of corticosteroids EITHER for > 14 days OR at dosages > 20 mg/day of prednisone or equivalent is prohibited
+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
+Patients with a total lifetime anthracycline exposure exceeding the equivalent of 900 mg/m^2 of daunorubicin
+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.
+Concurrent systemic immunosuppressant therapy (e.g., cyclosporine A, tacrolimus, etc., or chronic administration [> 14 days] of > 10 mg/day of prednisone) within 28 days of the 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 have received a cumulative dose of doxorubicin of greater than 360 mg/m^2 or epirubicin of greater than 640 mg/m^2
+Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone/ prednisolone once daily
+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
+Concomitant disease which requires continuous therapy with corticosteroids at doses equivalent to prednisolone >20 mg/day.
+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
+Patients must be on a stable or decreasing dose of corticosteroids within 5 days prior to CT scan or MRI (which is done to determine eligibility); patients must be on no more than 8 mg a day but an attempt should be made to keep the dose at 4 mg or less; please contact the PI if doses of > 4 mg are needed
+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.
+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
+Human immunodeficiency virus (HIV)-positive patients, patients with acquired or congenital immunodeficiency conditions, those on chronic systemic immunosuppressants (requiring > 10 mg of prednisone or equivalent/day), those with active autoimmune disease are excluded from the study
+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
+Participant may be receiving steroid therapy at time of enrollment (stable dose of ? 4 mg/day of dexamethasone or steroid equivalent).
+Patients who have received a cumulative doxorubicin equivalent of > 375 mg/m^2 total lifetime dose
+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
+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
+Chronic use (> 2 weeks) of corticosteroids (prednisone >= 10 mg/24 hour [hr] equivalent) within 4 weeks of screening
+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
+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
+Concurrent systemic steroid therapy higher than physiologic dose (> 7.5 mg/day of prednisone or equivalent)
+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.
+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 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
+Had treatment with a short course of corticosteroids (> 10mg daily prednisone equivalents) for symptom relief within 1-week prior to screening.
+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 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
+Subject requires escalating or chronic supraphysiologic doses of corticosteroids > 2 mg dexamethasone or equivalent
+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 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
+Patients who are on steroids (> 10 mg/day or equivalent) or immune suppression medications
+Patients who are on high dose steroid (equivalent of prednisone more than 10 mg a day) or immune suppression medications
+Corticosteroid use > 4 mg/day at time of consent
+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
+Steroid therapy for indications other than GVHD at doses > 0.5 mg/kg/d of methylprednisolone or equivalent within 7 days prior to initiation of GVHD treatment
+Immunosuppressive corticosteroid doses (>10mg prednisone) within 28 days prior to treatment with REGN2810
+Patients with clear cell histology must have demonstrated: 1) progression on at least one prior anti-angiogenic agent unless intolerable; AND 2) progression on at least one agent that blocks the PD-1 pathway unless felt by the treating physician to be contraindicated (examples include but are not limited to: patients with autoimmune disease or patients requiring systemic steroids greater than 10 mg/day prednisone or its equivalent) or if they have been discontinued due to toxicity; prior rapalogues are allowed
+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
+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)
+Primary immunodeficiency and need for chronic steroid therapy, exception: patients on chronic physiological dose of steroid equivalent to prednisone < 10 mg/day is allowed
+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 NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) 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 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
+Clinical status at enrollment to allow tapering of steroids to less than 0.5 mg/kg/day of prednisone
+Prior cumulative dose of doxorubicin of greater than 360 mg/m^2 or epirubicin of greater than 640 mg/m^2
+Have received systemic corticosteroids (used in the management of cancer or non-cancer-related illnesses) within one week prior to first dose; Note: systemic steroid therapy is allowed for subjects on replacement therapy as long as prednisone =< 10 mg or its steroid equivalent, and those patients should continue at the same dose through the trial
+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.
+Patients must be beyond day 30 and before day 75 after transplant
+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
+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
+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.
+Concurrent use of corticosteroids equivalent of prednisone at a dose > 0.5 mg/kg
+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
+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; 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
+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
+Systemic corticosteroid therapy > 2 mg of dexamethasone or equivalent per day at study entry
+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.
+Patients on greater than 4 mg per day of dexamethasone within the 2 weeks prior to admission for D2C7-IT infusion
+Clinical status at enrollment to allow tapering of steroids to equal or less than 0.5 mg/kg/day prednisone (or equivalent).
+Receiving corticosteroids > 20 mg of prednisone per day (or equivalent); Note: the dose should be noted on the medication record each cycle
+Chronic daily treatment with corticosteroids with a dose of greater than or equal to 10 mg/day methylprednisolone equivalent (excluding inhaled steroids).
+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)
+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
+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)
+Clinical status at enrollment to allow tapering of steroids equal to or less than 0.5 mg/kg/day of prednisone
+Patients receiving prednisone > 0.5 mg/kg/day at time of enrollment, or have received anti-thymocyte globulin (ATG), donor lymphocyte infusion (DLI) or Campath within 28 days of enrollment
+Clinical status to allow tapering of steroids to less than 0.5 mg/kg/day prednisone or equivalent
+Use of full-dose anticoagulant therapy; use of daily aspirin up to 325 mg per day is permitted
+Patients requiring high doses of glucocorticosteroids (? 0.3 mg/kg prednisone or its equivalent)
+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.
+Full resolution of ipilimumab related adverse events (AEs) to baseline (including immune related adverse events [irAEs]) off of steroid treatment (> 10 mg/day prednisone or equivalent dose) for irAEs for at least two weeks prior to first dose of study drug\r\n* No history of severe irAEs from ipilimumab of Common Terminology Criteria for Adverse Events (CTCAE) grade 4 requiring steroid treatment; no history of CTCAE grade 3 requiring steroid treatment (> 10 mg/day prednisone or equivalent dose) for > 12 weeks\r\n* Minimum of four weeks (wash out period) from the last dose of ipilimumab
+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)
+Clinical status at enrollment to allow tapering of steroids to equal or less than 0.5 mg/kg/day prednisone (or equivalent)
+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
+Chronic usage of aspirin greater than 81 mg/day
+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
+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)
+Primary immunodeficiency and need for chronic steroid therapy, however prednisone is allowed at < 10 mg/day (Turnstile I)
+Active GVHD or recent GVHD and still on > 10 mg prednisone (or equivalent)
+Systemic corticosteroid therapy must be at a dose of =< 4 mg of dexamethasone or equivalent per day during the week prior to day 1
+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
+Current or recent (within 10 days prior to first dose of bevacizumab) use of aspirin (> 325 mg/day)
+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
+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
+If receiving corticosteroids, ? 20 mg/day prednisone or equivalent and unchanged
+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
+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
+Current use of systemic corticosteroids > 0.5 mg/kg/day
+Patients on total daily dose of dexamethasone greater than 16 mg
+Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone/prednisolone bid
+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
+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).
+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
+Concurrent systemic immunosuppressant therapy (e.g., cyclosporine A, tacrolimus, etc., or chronic administration of > 20 mg/day of prednisone) within 28 days of the first dose of study drug
+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; 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
+Receiving corticosteroids above physiological dosing (> 5 mg per day of prednisone) within 28 days prior to anti-CD19-CAR-transduced T cell administration
+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
+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
+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.
+Patient with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before randomization
+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
+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);
+Use of any medication or herbal products that may have hormonal anti-prostate cancer activity and/or are known to modulate PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone per day within 4 weeks of enrollment
+?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.
+Patients on systemic corticosteroids (>10 mg prednisone per day or equivalent) or other systemic immunosuppressive drugs
+No chronic systemic corticosteroids (defined as the equivalent of prednisone >= 20 mg orally [PO] daily for > 6 months during the past year)
+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
+Patients who are receiving high dose steroids (more than a dexamethasone-equivalent dose of 4 mg per day).
+Receiving systemic steroids exceeding 10 mg prednisone or equivalent, or unstable on steroid medication, during the 3 weeks immediately preceding enrollment
+Autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenia purpura (ITP) that is uncontrolled or requires >20 mg daily (QD) of prednisone (or equivalent) to maintain hemoglobin >8.0 g/dL or platelets >10,000 ?L without transfusion support
+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
+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
+Systemic corticosteroids at physiologic doses ?10 mg/day of prednisone or equivalent are permitted;
+History of exposure to cumulative doses of doxorubicin greater than 360 mg per square meter of body-surface area or its equivalent
+Chronic treatment for more than 6 months with systemic corticosteroids at doses above 10 mg prednisolone or equivalent before study entry
+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.
+Prednisone dose ? 20 mg/day
+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
+Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of randomization
+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.
+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
+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
+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 (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
+Chronic use of corticosteroids in excess of prednisone 20 mg/day or its equivalent
+Systemic corticosteroid therapy is permitted provided dosing is no greater than 4 mg per day (dexamethasone or equivalent) on the day of vaccine administration.
+Concurrent systemic immunosuppressant therapy (e.g., cyclosporine A, tacrolimus, etc., or chronic administration [> 14 days] of > 60 mg/day of prednisone or equivalent) within 28 days of the first dose of study drug
+Receiving immunosuppressive agents or > 10 mg daily prednisone or equivalent of corticosteroids
+Systemic corticosteroid therapy, > 8 mg of dexamethasone daily (or equivalent) at study enrollment
+Patients with prior allogeneic hematopoietic cell transplantation (HCT) must be at least 90 days post-HCT and must be on =< 20 mg of prednisone (or equivalent dose of an alternative corticosteroid) for treatment/prevention of graft-vs-host disease
+Prior treatment with small molecule BET family inhibitor or receiving steroids >the equivalent of 10mg prednisone daily
+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
+Chronic corticosteroid use in excess of the equivalent of prednisone 10 mg once daily
+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
+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.
+Daily requirement for corticosteroids (> 10 mg prednisone daily or equivalent) (except for inhalation corticosteroids) within 2 weeks prior to Cycle 1, Day 1
+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
+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.
+Chronic corticosteroid use in excess of the equivalent of prednisone 10 mg once daily
+Concurrent use of high dose steroids; chronic steroid use of < 2 mg dexamethasone or equivalent per day is permissible
+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
+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
+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)
+Any condition requiring > 10 mg/d prednisone equivalents
+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
+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; note: a history of mild asthma not requiring therapy is eligible
+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
+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
+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
+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
+A patient's daily total dose of dexamethasone must be =< 16 mg by day 4
+Chronic daily treatment with corticosteroids with a dose of >= 10 mg/day methylprednisolone equivalent (excluding inhaled steroids)
+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 not be receiving concurrent steroids > 10 mg prednisone (or equivalent)\n             per day.
+Concurrent steroids allowed (up to equivalent of prednisone 20 mg daily, on taper or stable dose for at least 2 weeks)
+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
+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
+Patients receiving a stable dose (> 4 weeks) of corticosteroid therapy equivalent to 20 mg of prednisone per day or less are eligible
+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 treated brain or meningeal metastases must be without magnetic resonance imaging (MRI) evidence of progression for at least 8 weeks and off immunosuppressive doses of systemic steroids (> 10 mg/day prednisone or equivalent) for 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
+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
+Patients must have completed prednisone taper (5 mg - 2.5 mg) prior to randomization
+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
+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.
+If the subject has a history of maximum Grade 1 or 2 GVHD that was treated with systemic steroid (? 0.5 mg/kg/day prednisone equivalents) or other non-steroid systemic IST, the subject must be off all IST for at least 2 weeks, and must have ceased treatment doses of steroids for GVHD (? 0.5 mg/kg/day prednisone equivalents) for at least 4 weeks. o If the subject has a history of Grade 3 or greater GVHD, the subject must be off all systemic IST for 4 weeks o Topical therapy is permitted and does not imply the subject has active acute or chronic GVHD.
+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
+Prior treatment with anthracyclines at cumulative doses of 450 mg/m² or more for doxorubicin or 900 mg/m² or more for epirubicin
+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.
+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.
+Any corticosteroid therapy for indications other than GVHD at doses of methylprednisolone or equivalent > 1 mg/kg per day within 7 days of enrollment.
+Requires treatment with high dose systemic corticosteroids defined as >2 mg/day
+Non-escalating corticosteroid dose (not exceeding more than 16 mg daily of dexamethasone oral) for >= 5 days
+Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of REGN2810
+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.
+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
+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
+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
+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
+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
+Prior exposure to cumulative doses of doxorubicin >400 mg/m2 or epirubicin >720 mg/m2
+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.).
+Daily requirement for corticosteroids ? prednisone 10 mg/day or equivalent.
+No more than 16 mg dexamethasone (or equivalent) per day
+K+ or Mg+ < LLN.
+Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone 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
+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)
+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
+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
+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
+Patients must not be receiving chronic treatment (equivalent of prednisone > 10 mg/day) with systemic steroids or other immuno-suppressive agent
+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
+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).
+Steroid use equivalent to greater than 20 mg of prednisone within 4 weeks (28 days) prior to Day 1.
+No corticosteroids, or on a stable or decreasing dose of ? 10 mg daily prednisone (or equivalent)
+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.
+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
+Chronic use (? 2 weeks) of corticosteroids (? 10 mg/24 hr equivalent prednisone) within 4 weeks of Baseline/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.
+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
+Prior treated brain or meningeal metastases must be without magnetic resonance imaging (MRI) evidence of progression for at least 8 weeks and off immunosuppressive doses of systemic steroids (> 10 mg/day prednisone or equivalent) for at least 2 weeks before study drug administration
+Current or recent (within 10 days prior to the first study drug dose) chronic daily treatment with aspirin (> 325 mg/day)
+Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents within 2 weeks prior to cycle 1, day 1; patients who have received acute and/or lowrolment, or anticipation of need for major surgical, a one-time dose of dexamethasone for nausea or chronic use of =< 10 mg/day of prednisone or dose-equivalent corticosteroid) may be enrolled in the study after discussion with and approval by the medical monitor; the use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) is allowed; prior corticosteroids as anti-cancer therapy within a minimum of 14 days of first receipt of study drug
+Concurrent systemic immunosuppressant therapy (e.g., cyclosporine, tacrolimus, etc., or chronic administration glucocorticoid equivalent of > 10 mg/day of prednisone) within 28 days of the first dose of study drug
+Chronic daily treatment with oral corticosteroids (dose of > 10 mg/day prednisone equivalent) or other immunosuppressive medications within 14 days of randomization
+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)
+Requirement for chronic immunosuppressive medication including systemic corticosteroids above the physiologic dose (30 mg/day hydrocortisone or the equivalent).
+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
+Concurrent systemic immunosuppressant therapy (eg, cyclosporine A, tacrolimus, etc., or chronic administration [> 14 days] of > 20mg/day of prednisone) within 14 days of the first dose of study drug
+Systemic corticosteroid therapy is permitted provided dosing is no greater than 4 mg per day (dexamethasone or equivalent) on the day of vaccine administration
+Patients receiving concomitant immunosuppressive agents or chronic corticosteroids (?10 mg of prednisone or equivalent) at the time of first study dose.
+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
+Low dose aspirin (? 100 mg daily).
+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
+Concurrent systemic immunosuppressant therapy (e.g., cyclosporine A, tacrolimus, etc., or chronic administration [> 14 days] of > 10 mg/day of prednisone) within 28 days of the first dose of study drug (prednisone should not be started during screening or be given during the study for treatment of mastocytosis)
+Absence of active GVHD and off immunosuppression; subjects on tapering prednisone will be eligible if their dose is 0.25 mg/kg or less and being actively tapered; we suggest a 28 day waiting period off of immunosuppression but some subjects with rapidly progressive disease may need to be treated before 30 days and will still be eligible
+Requires escalating or chronic supraphysiologic doses of corticosteroids (> 10 mg/day prednisone equivalents)
+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
+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
+Prior failure to tolerate regorafenib at 120 mg/day
+Participants with ongoing corticosteroid use >30 mg per day of prednisone or equivalent
+Treatment including chemotherapy, chemo-immunotherapy, monoclonal antibody therapy, radiotherapy, high-dose corticosteroid therapy (more than 60 mg prednisone daily or equivalent), or immunotherapy within 21 days prior to enrollment or concurrent with this trial
+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.
+Patients must not require more than 20 mg prednisone or equivalent corticosteroid daily
+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)
+Clinical status at enrollment to allow tapering of steroids to less than 0.5 mg/kg/day prednisone at time of treatment
+No prior therapy for MCL, except: < 2 weeks of steroid therapy for symptom control or local radiation therapy for symptom control if there is measurable disease outside the radiation portal; patients may be on chronic steroids for non-malignant disease if on a stable dose equivalent to =< 20 mg prednisone per day
+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.
+Patients requiring concurrent systemic steroid therapy higher than physiologic dose (7.5 mg/day of prednisone).
+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
+Subjects on systemic intravenous or oral corticosteroid therapy with the exception of physiologic doses of corticosteroids (=< the equivalent of prednisone 10 mg/day) or other immunosuppressives such as azathioprine or cyclosporin A are; for these subjects these excluded treatments must be discontinued at least 2 weeks prior to enrollment for recent short course use (=< 14 days) or discontinued at least 4 weeks prior to enrollment for long term use (> 14 days); in addition, the use of corticosteroids as premedication for contrast-enhanced studies is allowed prior to enrollment and on study
+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.
+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
+Patients who have evidence of active, noninfectious pneumonitis or have a history of severe pneumonitis that required treatment with steroids are not eligible for this study; (Note: replacement physiologic dose of steroids [prednisone 10 mg daily or equivalent] are allowed)
+Current or recent (=< 10 days prior to randomization) use of aspirin (> 325 mg/day), or clopidogrel (> 75 mg/day)
+Participants who have had < 28 days since the last chemotherapy, immunotherapy, biological therapy, or < 14 days from approved tyrosine kinase inhibitor (TKI) therapy (sunitinib, sorafenib, vemurafenib, dabrafenib, cobretinib), or systemic or inhaled steroid therapy at doses greater than 10mg of prednisone or equivalent before administration of the first dose of study medication.
+Patients must have primary refractory ALL based on failure to achieve a hematologic or molecular remission after induction therapy with dasatinib and steroids or dasatinib and chemotherapy, or have relapsed after treatment with a tyrosine kinase inhibitor with or without chemotherapy\r\n* Note: Prior course of dasatinib and steroid induction therapy should have included dasatinib 140mg PO daily on days 1-84 and prednisone 60mg/m^2 (capped at 120mg, or equivalent steroid dose) on days 1-28; if patients were unable to tolerate full steroid dose during induction therapy they will still be eligible\r\n* Note: Patients with refractory or relapsed disease in the central nervous system will be eligible
+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
+Patients who are on high dose steroid (i.e. prednisone or equivalent more than 10 mg a day) or immune suppression medications
+Concurrent systemic immunosuppressant therapy (e.g., cyclosporine, tacrolimus, etc., or chronic administration glucocorticoid equivalent of > 10 mg/day of prednisone) within 28 days of the first dose of study drug
+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
+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
+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
+Patient has received no prior treatment with any systemic therapy for the treatment of multiple myeloma\r\n* Prior treatment of hypercalcemia or spinal cord compression with corticosteroids does not disqualify the patient (the dose should not exceed the equivalent of 160 mg of dexamethasone in a 2 week period)\r\n* Patients may receive corticosteroids for the management of their multiple myeloma that should not exceed the equivalent of 160 mg of dexamethasone in a 2 week period and should be stable for at least 7 days prior to the initiation of therapy \r\n* Bisphosphonates are permitted\r\n* Patients treated with local radiotherapy with or without concomitant exposure to steroids, for pain control or management of cord/nerve root compression, are eligible; two weeks must have lapsed since last date of radiotherapy, which is recommended to be a limited field; patients who require concurrent radiotherapy should have entry to the protocol deferred until the radiotherapy is completed
+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
+Glucocorticoid therapy within the 14 days prior to randomization that exceeds a cumulative dose of 160 mg of dexamethasone or 1000 mg prednisone
+Has a diagnosis of immunodeficiency or is receiving chronic steroid therapy of prednisone ? 10 mg daily or any equivalent dose of corticosteroids.
+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)
+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)
+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
+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)
+Patient requires more than 8 mg of dexamethasone daily or the equivalent
+Systemic anticoagulation or daily aspirin dose exceeding 325 mg per day
+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
+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
+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
+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
+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
+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)
+Use of herbal products that may decrease PSA levels (i.e., saw palmetto) or systemic corticosteroid greater than the equivalent of 10 mg of prednisone per day during the 4 weeks prior to screening or plans to initiate treatment with the above during the entire duration of the study
+Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of replacement steroids or > equivalent of 10 mg of prednisone per day within 4 weeks of enrollment (day 1 visit)
+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
+Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone/prednisolone bid.
+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
+Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone bid
+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)
+Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenia purpura (ITP) that is uncontrolled or requiring > 20 mg once daily (QD) of prednisone (or equivalent) to maintain hemoglobin > 8.0 g/dL or platelets > 10,000 ?L without transfusion support
+Ongoing treatment with chronic immunosuppressants (eg, cyclosporine) or systemic steroids > 20 mg prednisone (or equivalent) QD
+Current chronic daily treatment (continuous for > 3 months) with corticosteroids (dose equivalent to or greater than 10 mg/day methylprednisolone), excluding inhaled steroids
+Patient had prior exposure to a cumulative dose of doxorubicin that exceeded 360 mg/m2 or its equivalent.
+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)
+Chronic daily treatment with corticosteroids with a dose of greater than or equal to 10 mg/day methylprednisolone equivalent (excluding inhaled steroids).
+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.
+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
+Therapeutic doses of corticosteroids (defined as > 20 mg/day prednisone or equivalent) within 7 days prior to leukapheresis
+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
+No chronic use of systemic steroids greater than the equivalent of 10 mg of prednisone/prednisolone per day within 4 weeks prior to enrollment
+Participants may have had any number of previous hormonal therapies (antiandrogens, steroids, estrogens, finasteride, dutasteride, ketoconazole, abiraterone) provided these were discontinued >= 4 weeks before enrollment; participants on prednisone 10 mg daily or another equivalent steroid dose are eligible; participants on inhaled steroid are eligible
+Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone/prednisolone bid
+Patients on total daily dose of dexamethasone greater than 16 mg/day
+Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone per day within 2 weeks of enrollment
+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
+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
+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
+Must be able to take concurrent aspirin 70mg to 325 mg daily (or enoxaparin if aspirin allergic)
+Deemed eligible to receive neoadjuvant chemotherapy with 12 cycles of weekly taxane therapy (paclitaxel 80 mg/m2 or abraxane 100 mg/m2 if there is a shortage of paclitaxel) followed by 4 cycles of adriamycin (60 mg/m2) and cyclophosphamide (600 mg/m2) given every 2 weeks with growth-factor support
+Requirement for steroid use greater than 10 mg of prednisone daily
+Use of systemic steroids at an equivalent dose of prednisone 5 mg/day or higher at randomization
+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
+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
+Any chemotherapy (e.g., hydroxyurea), immunomodulatory drug therapy (e.g., thalidomide), immunosuppressive therapy, corticosteroids > 10 mg/day prednisone or equivalent, growth factor treatment (e.g., erythropoietin) or Janus kinase (JAK) inhibitor therapy =< 14 days prior to registration
+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 with prior cumulative anthracycline exposure of greater than 368 mg/m2 daunorubicin (or equivalent).
+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
+Current treatment with immunosuppressive agents other than prescribed corticosteroids (not more than 10-mg prednisone equivalent).
+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
+Previous systemic glucocorticoid therapy (at >= 1 mg/kg/day prednisone or equivalent) for chronic GVHD\r\n* Prior systemic glucocorticoid therapy for acute GVHD is permitted\r\n* Prior or ongoing systemic immune suppressive agents (including, but not limited to common examples such as calcineurin inhibitors, sirolimus, mycophenolate mofetil) provided for either prevention or treatment of acute GVHD are permitted and part of routine standard of care\r\n* Patients with progressive, uncontrolled manifestations of acute or chronic GVHD despite >= 1mg/kg/day prednisone (or equivalent) therapy have steroid-refractory disease, and are therefore not eligible for this study
+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
+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
+Patients taking greater than 12 mg daily of dexamethasone
+Oral corticosteroids >= 7.5 mg/day prednisone (or prednisone equivalents)
+Therapy with other hormonal therapy, including any dose of megestrol acetate (Megace), finasteride (Proscar), dutasteride (Avodart), or any herbal product known to decrease PSA levels (e.g., saw palmetto and PC-SPES), or any systemic corticosteroid (other than prednisone =< 10 mg/day) within 4 weeks prior to first dose of study drug
+Current or recent (=< 10 days prior to randomization) use of aspirin (> 325 mg/day), clopidogrel (> 75 mg/day), or prasugrel (> 10 mg/day)
+No medical condition requiring chronic use of high dose systemic corticosteroids (i.e., doses of prednisone higher than 10 mg/day or equivalent)
+Maximum prior cumulative doxorubicin dose of =< 360 mg/m^2 or equivalent
+The patient requires treatment with corticosteroids at a dose > 0.1 mg/kg/day or has a known allergy to DSMO
+Patients receiving any herbal product known to decrease PSA levels (i.e. saw palmetto and prostate cancer [PC]-SPES), or any immunosuppressive dose of systemic or absorbable topical corticosteroid (except prednisone up to 10 mg orally per [q] day, or its equivalent), must discontinue the agent for at least 2 weeks prior to screening; progressive disease must be documented after discontinuation of these products
+Concomitant therapy with any of the following: interleukin (IL)-2, interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents (over the counter [OTC]/herbal/prescribed); immunostimulant agents, other than the study agent; other investigational therapies; or chronic use of systemic corticosteroids (greater than prednisone 10 mg orally per day, or its equivalent)
+Patients on greater than 4 mg per day of dexamethasone within the 2 weeks prior to admission for PVSRIPO infusion
+Use of 81-100 mg daily aspirin or up to 700 mg aspirin not more than once a week are eligible.
+Patient on corticosteroids within two weeks prior to study entry, except for prednisone < = 10 mg/day or equivalent for purposes other than treating MCL.
+Chronic systemic steroids (>10 mg/day Prednisone equivalents) or any other immunosuppressive agents
+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.
+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
+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
+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
+Corticosteroid doses > 10 mg/day of prednisone or equivalent within 14 days prior to cycle 1 day 1
+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
+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
+Prior treatment with cumulative dose of doxorubicin or equivalent exceeding 450 mg/m2
+Receiving corticosteroids > 20 mg of prednisone per day (or equivalent)
+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
+Patients requiring concurrent systemic steroid therapy higher than physiologic dosage (>10mg/day of prednisone or equivalent).
+Patients with known central nervous system, meningeal, or epidural disease. Patients with stable brain metastases following definitive local treatment are eligible if steroid requirement is <10 mg/day of prednisone (or equivalent).
+Concurrent systemic immunosuppressant therapy (e.g., cyclosporine A, tacrolimus, etc., or chronic administration of > 20 mg/day of prednisone) within 28 days of the first dose of study drug
+Participants with a diagnosis of immunodeficiency or who are receiving chronic systemic steroid therapy (doses exceeding 10 mg/day of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. Physiologic doses of corticosteroids (up to 10 mg/day of prednisone or equivalent) may be used during the study
+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.
+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
+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.
+Ongoing corticosteroid use >30 milligrams per day (mg/day) prednisone or equivalent
+Able to take aspirin 81 mg daily
+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
+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).
+Patients must be tapered off systemic steroids to a dosage of less than or equal to 0.25 mg/kg/day
+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.
+Any condition requiring chronic use of moderate/high dose steroids (equivalent to 10 mg QD prednisone).
+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
+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.
+Requirement for drugs, juices and/or herbs strongly inhibit CYP3A4 from within 7 days prior to D1 of alisertib and throughout treatment; NOTE: glucocorticoids are considered inducers of CYP3A4; however, their use is allowed if patient has been taking a continuous dose of no more than 15 mg/day of prednisone (or its equivalent) for at least 1 month prior to D1 of alisertib; in addition, low dose steroid use for the control of nausea and vomiting will be allowed; topical steroid use and inhaled steroids are also permitted
+For Post-allo Part B: Concurrent use of corticosteroids equivalent of prednisone at a dose of greater than 0.5 mg/kg
+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
+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):
+Prior anthracycline therapy with a cumulative dose of doxorubicin (or equivalent) >= 400 mg/m^2
+Chronic use of systemic corticosteroids (i.e., >= 10 mg/day prednisone or equivalent)
+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.
+Current use of systemic corticosteroids (> 5 mg prednisone)
+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
+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.
+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
+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)
+RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Body surface area (BSA) \r\n* Patients must have a BSA >= 0.80 m^2 for dose 5 mg/m^2\r\n* Patients must have a BSA >= 0.65 m^2 for doses of 10 mg/m^2 - 22 mg/m^2 \r\n* Patients must have a BSA >= 0.50 m^2 for doses of 28 mg/m^2 - 36 mg/m^2
+NON-PROGRESSED DIPG (STRATUM 2): BSA\r\n* Patients must have a BSA >= 0.80 m^2 for dose 5 mg/m^2\r\n* Patients must have a BSA >= 0.65 m^2 for doses of 10mg/m^2 - 22 mg/m^2\r\n* Patients must have a BSA >= 0.50 m^2 for doses of 28 mg/m^2 - 36 mg/m^2
+The following medications are prohibited during the study:\r\n* Immunosuppressive agents (except to treat a drug-related adverse event) are prohibited during the study\r\n* Systemic corticosteroids > 10 mg daily prednisone equivalent\r\n* Any concurrent chemotherapy, hormonal therapy, immunotherapy, or investigational agents for treatment of cancer are prohibited during the study
+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.
+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.
+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)
+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
+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.
+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.
+Clinical status at enrollment to allow tapering of steroids to equal or less than 0.5 mg/kg/day prednisone (or equivalent).
+Any prior cumulative doxorubicin dose must be ? 360 mg/m2; prior cumulative epirubicin dose must be ? 720 mg/m2.
+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
+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.
+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
+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.
+Epirubicin >530 mg/m².
+Mitoxantrone >90 mg/m² and idarubicin > 70 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.
+Have received a cumulative dose of corticosteroid ? 150 mg (prednisone or equivalent doses of corticosteroids) within two weeks before the first infusion.
+Bilirubin >=1.5 mg/dL (> 26 mol/L, International System [SI] unit equivalent)
+Receiving chronic systemic corticosteroid therapy > 20 mg of prednisone daily
+Patients with prior cumulative anthracycline exposure of greater than 368 mg/m2 daunorubicin (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
+Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs (NSAIDs), inhaled corticosteroids, or the equivalent of less than or equal to (</=) 10 mg/day prednisone
+Chronic daily treatment with corticosteroids (dose > 10 mg/day methylprednisolone equivalent) excluding inhaled steroids
+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.
+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 immunosuppressive therapies (includes daily steroid doses in excess of 20 milligrams [mg]/day of 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
+Clinical status at enrollment to allow tapering of steroids to less than 0.5 mg/kg/day prednisone
+Glucocorticoid therapy (prednisone > 30 mg/day or equivalent within 14 days of first dose)
+Treatment with oral steroids (dose ? 10 mg/day of methylprednisolone or equivalent)
+Glucocorticoid therapy (prednisone > 30 mg/day or equivalent) within 14 days prior to randomization
+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
+Receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent ? 5 mg prednisone or equivalent daily.
+Use of systemic steroids at an equivalent dose of prednisone 5 mg/day or higher within 6 weeks of day 1 of protocol therapy
+Glucocorticoid therapy (prednisone > 10 mg/day or equivalent) within the last three weeks
+No 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; NOTE: history of mild asthma not requiring daily therapy is eligible
+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.
+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.
+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.)
+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
+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
+Ongoing corticosteroid use >30 mg per day prednisone or equivalent, for purposes other than lymphoma symptom control
+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.
+Chronic corticosteroid use equivalent to >= prednisone 10 mg daily
+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
+Daily steroids of > 0.5 mg/kg prednisone or glucocorticoid equivalent, methotrexate, or extracorporeal photopheresis
+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
+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
+Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of REGN2810
+Glucocorticoid therapy (prednisone > 30 mg/day or equivalent) within 14 days prior to randomization.
+Active autoimmune hemolytic anaemia (AIHA) and idiopathic thrombocytopenic purpura (ITP) requiring corticosteroid therapy greater than 25 mg prednisone (or equivalent) or chemotherapy.
+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.
+Daily requirement for corticosteroids (except for inhalational corticosteroids); prednisone =< 10mg/day or equivalent is permitted for other medical conditions
+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
+Ongoing corticosteroid use with > 10 mg of daily prednisone or equivalent
+Concurrent steroids are allowed if dexamethasone dose is =< 16mg daily; if feasible, steroids should be weaned off once sorafenib has been initiated
+Receiving chronic daily treatment with aspirin (> 325 mg/day) or other known inhibitors of platelet function
+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
+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
+Systemic corticosteroid therapy > 2 mg of dexamethasone or equivalent (as defined by the investigator) per day at study enrollment.
+Patients with prior cumulative anthracycline exposure of greater than 368 mg/m2 daunorubicin (or equivalent)
+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
+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)
+Prior treatment with anthracyclines at cumulative doses of 450 mg/m² or more for doxorubicin or 900 mg/m² or more for epirubicin
+Concurrent systemic steroid therapy higher than physiologic dose (> 7.5 mg/day 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
+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
+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
+Patient must not have evidence of any 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
+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
+Prednisone equivalent of > 2m/kg for treatment of GVHD prior to administration of ibrutinib
+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)
+Uncontrolled pain; if patient is on opioids for the treatment of cancer pain, he/she must have had no major dose change (> 25%) for at least 48 hours prior to study entry; the dose of morphine equivalent daily should not exceed 120 mg/day unless approved by the principal investigator (PI); change in opioid dose after study entry is allowed
+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)
+Patients taking more than 81 mg of Aspirin daily
+Pain score of at >= 5 on a scale of 0 – 10 within a week of enrollment OR pain score < 5 with >= 60 mg of morphine (or equivalent) per day
+Chronic opioid use as defined by use of more than 20 mg oxycodone, or equivalent, daily
+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)
+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
+Patients requiring high doses of glucocorticosteroids (>= 0.3 mg/kg prednisone or its equivalent)
+Patient is scheduled to receive adjuvant temozolomide at either 150 mg/m^2 or 200 mg/m^2 PO x 5 days out of a 28 day cycle +/- bevacizumab
+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)
+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
+Patients receiving the initial course of chemotherapy including \r\n* Paclitaxel 135 mg/M2 IV over 3 hours on day 1 and \r\n* Cisplatin 75 mg/M2 IP on day 2  OR  \r\n* Paclitaxel 80 mg/m2 IV days 1, 8 and 15 and \r\n* Carboplatin AUC 6 IP on day 1
+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
+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
+Corticosteroid use > 10 mg prednisone/day
+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
+On strong opioid intravenous continuous infusion morphine equivalent daily dose (MEDD) >= 70 mg/day at the time of enrollment
+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
+Systemic steroid therapy or any immunosuppressive therapy (?10mg/day prednisone or equivalent).
+Concurrent systemic immunosuppressant therapy (eg, cyclosporine A, tacrolimus, etc., or chronic administration [> 14 days] of > 60 mg/day of prednisone) within 28 days of the first dose of study drug
+Concurrent systemic immunosuppressant therapy (e.g., cyclosporine A, tacrolimus, etc., or chronic administration of > 20 mg/day of prednisone) within 28 days of the first dose of study drug
+Is receiving high dose corticosteroids (>10 mg prednisone daily or equivalent);
+Patient requires more than 8 mg of dexamethasone daily or the equivalent
+Patient is using systemic immunosuppressant therapy, including cyclosporine A, tacrolimus, sirolimus, and other such medications, or chronic administration of > 5 mg/day or prednisone or the equivalent; participants must be off of immunosuppressant therapy for at least 28 days prior to the first dose of the study drug
+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)
+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
+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
+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]).
+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 with a history of severe chronic pain on high dose narcotics (> 25 mg of oxycodone or equivalent daily) preceding diagnosis of cancer
+Clinical status at enrollment to allow tapering of steroids to less than 0.5 mg/kg/day prednisone
+Planned concurrent administration of cisplatin chemotherapy (either 100 mg/m^2 every 3 weeks or 30-40 mg/m^2 every week)
+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)
+Current use of systemic corticosteroids at doses > 10mg/day prednisone or its equivalent; those receiving =< 10mg may be enrolled at discretion of investigator
+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
+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
+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
+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
+Patient must start everolimus 10mg plus exemestane 25mg treatment on Cycle 1 Day 1 of trial
+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
+Requires immunosuppressive doses of corticosteroid therapy (> 10 mg/day prednisone equivalents) for >= 2 weeks prior to registration
+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.
+Corticosteroids are allowed, but must be dosed at prednisone 20 mg (or equivalent) or lower prior to the start of chemotherapy
+Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone per day within 4 weeks of enrollment
+Prior exposure to anthracyclines at a cumulative dose of doxorubicin (or equivalent) > 450 mg/m²