Patients must not have a condition requiring systemic corticosteroids equivalent to >  mg prednisone per day or other immunosuppressive medications within  weeks of randomization; inhaled, intra-articular, and epidural steroids are permissible
No ongoing therapy with corticosteroids greater than  mg of prednisone or its equivalent per day; please note: inhaled and topical steroids are permitted
Use of any systemic immunosuppressive treatments including corticosteroids, cyclosporine, mycophenolate mofetil et cetera, ongoing or within the last  months prior to day  of treatment\r\n* (NOTE: Patients on physiologic dose of corticosteroids [=<  mg/day of prednisone or equivalent] for long-term hormone-replacement therapy or those requiring short, intermittent courses of corticosteroids for hypersensitivity prophylaxis [such as for iodinated computed tomography (CT) contrast prophylaxis] or those using intranasal, inhaled, topical steroids, or local steroid injection [e.g., intra-articular injection] can be allowed)
Subject currently using or have received immunosuppressive medications within  days prior to the first dose of KHK, with the exception of topical or systemic corticosteroids that are not to exceed  mg/day of prednisone or equivalent;
Ongoing immunosuppressive therapy including systemic corticosteroids (prednisone or equivalent =<  mg daily allowed as clinically warranted); patients are allowed to use topical or inhaled corticosteroids
Subjects currently receiving systemic corticosteroids above  mg daily of prednisone or equivalent for more than  days; subjects receiving other systemic immunosuppressive drugs greater than  mg prednisone or equivalent for more than  days; exceptions include: inhaled, intranasal, ophthalmic, and topical corticosteroids, local corticosteroid injections (e.g., intra-articular injections), and subjects requiring corticosteroid pre-medication for hypersensitivity reactions (e.g. computed tomography [CT] scan pre-medication)
Concurrent medical condition requiring the use of immunosuppressive medications, or systemic or topical corticosteroids; systemic or topical corticosteroids must be discontinued at least  weeks prior to enrollment. Inhaled or intranasal corticosteroids (with minimal systemic absorption may be continued if the subject is on a stable dose). Non-absorbed intra-articular steroid injections will be permitted; or use of other investigational drugs (drugs not marketed for any indication) within  days prior to study drug administration. Use of steroids as prophylactic treatment for subjects with contrast allergies to diagnostic imaging contrast dyes will be permitted;
Concurrent systemic therapy with immunosuppressive agents; use of hormonal agents within  days before the start of trial treatment. Note: subjects receiving bisphosphonate or denosumab are eligible provided treatment was initiated at least  days before the first dose of avelumab. Subjects receiving immunosuppressive agents (such as corticosteroids) for any reason should be tapered off these drugs before initiation of the study treatment (with the exception of subjects with adrenal insufficiency, who may continue corticosteroids at physiologic replacement dose, equivalent to ?  mg prednisone daily). Steroids with no or minimal systemic effect (topical, inhalation) are allowed.
Prior to the start of voruciclib therapy, subjects may be using systemic corticosteroids (? mg/day of prednisone or equivalent), topical, or inhaled corticosteroids
Treatment with an immunosuppressive regimen of corticosteroids or other immunosuppressive medication (e.g., methotrexate, rapamycin) within  days of study treatment; Note: patients may take up to  mg of prednisone or equivalent daily; topical and inhaled corticosteroids in standard doses are allowed
Corticosteroid use =<  days prior to registration; NOTE: Patients must be off systemic corticosteroids for at least  weeks prior to registration; this includes oral or IV route of administration; patients on chronic corticosteroids for adrenal insufficiency or other reasons may enroll if they receive less than  mg/day of prednisone (or equivalent); patients receiving inhaled or intranasal or intra-articular steroids are not excluded
Treatment with systemic corticosteroids or other systemic immunosuppressive medications within past  weeks or  half-lives whichever is shorter. Use of inhaled or topical steroids or systemic corticosteroids <  mg/day of prednisone (or equivalent) is permitted
Chronic administration (defined as daily or every other day for continued use >  days) of systemic corticosteroids within  days before the first planned dose of investigational therapy; use of corticosteroids with minimal systemic absorption (e.g. inhaled steroids, nasal sprays, and topical agents) is allowed
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within  days prior to the first dose of trial treatment; systemic corticosteroids of less than  mg per day of prednisone (or equivalent) are allowed; topical corticosteroids are acceptable, including steroids with very low solubility administered nasally for local effects only (e.g. Nasonex)
Current or prior use of any immunosuppressive medications, such as corticosteroids, within  days before enrollment\r\n* Oral hydrocortisone, only for the purposes of a documented and confirmed adrenal insufficiency diagnosis, is permitted if =<  mg daily total dose\r\n* Inhaled, intranasal, or topical corticosteroids are permitted
Need for systemic corticosteroids >  mg prednisone daily or equivalent alternative steroid (except physiologic dose for adrenal replacement therapy) or other immunosuppressive agents (such as cyclosporine or methotrexate); use of topical and inhaled corticosteroids is permitted
Concurrent treatment with systemic corticosteroids (prednisone dose >  mg per day or equivalent) or other immunosuppressive drugs <  days prior to treatment initiation. Steroids that are topical, inhaled, nasal (spray), or ophthalmic solution are permitted.
Patients must be off all systemic immunosuppressive drugs including corticosteroids at any dose for at least  days prior to protocol enrollment and must remain off immunosuppressive drugs while enrolled on the protocol; patients must not be taking any systemic steroids at all for  days prior to apheresis and initiation of chemotherapy; topical corticosteroid preparations applied to the skin such as solutions, creams, and ointments are allowed; inhaled corticosteroids are allowed, and corticosteroid eye drops are allowed
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within  days prior to the first dose of trial treatment; subjects may use topical or inhaled corticosteroids or low-dose steroids (=<  mg of prednisone or equivalent per day) as therapy for comorbid conditions; during study participation, subjects may receive systemic or enteric corticosteroids as needed for treatment-emergent comorbid conditions
Medical need for systemic corticosteroids >  mg prednisone daily or equivalent alternative steroid (except physiologic dose for adrenal replacement therapy) or other immunosuppressive agents (such as cyclosporine or methotrexate); topical and inhaled corticosteroids are allowed if medically needed
Has received the following within  days prior to study day :\r\n* Allergy desensitization injections\r\n* Systemic corticosteroids of more than  mg per day of prednisone (or equivalent), and administered parenterally or orally, except for physiologic replacement; inhaled steroids (e.g. Advair, Flovent, Azmacort) are not permitted; topical corticosteroids are acceptable, including steroids with very low solubility administered nasally for local effects only (e.g. Nasonex)
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within  days prior to the first dose of trial treatment; subjects may use topical or inhaled corticosteroids or low-dose steroids (=<  mg of prednisone or equivalent per day) as therapy for comorbid conditions; during study participation, subjects may receive systemic or enteric corticosteroids as needed for treatment-emergent comorbid conditions
Has a diagnosis of immunosuppression or is receiving ongoing immunosuppressive therapy, including systemic or enteric corticosteroids for treatment of lymphoid cancer or other conditions\r\n* Note: subjects may use topical or inhaled corticosteroids or low-dose steroids (=<  mg of prednisone or equivalent per day) as therapy for comorbid conditions; during study participation, subjects may also receive systemic or enteric corticosteroids as needed for treatment-related toxicities
Treatment with an immunosuppressive regimen of corticosteroids or other immunosuppressive medication (e.g., methotrexate, rapamycin) within  days of study treatment; Note: subjects may take up to  mg of prednisone or equivalent daily; topical and inhaled corticosteroids in standard doses are allowed
Therapeutic doses of corticosteroids within  days prior to study entry, defined as >  mg/day of prednisone, or equivalent; topical and/or inhaled steroids are permitted
Patient has history of primary immunodeficiency OR has received any other form of immunosuppressive therapy within  days prior to the first dose of trial treatment, excluding intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses; attempts should be made to have patient on lowest possible dose of steroids (acceptable range - mg, please contact PI if dose is >  mg) and weaned to off as is feasible
Planned use of corticosteroids (>  mg/day prednisone or equivalent) or other systemic immunosuppression within  days prior to leukapheresis; topical and/or inhaled steroids are permitted
Planned use of corticosteroids (>  mg/day prednisone or equivalent) or other systemic immunosuppression is not permitted within  hours prior to JCAR infusion; topical and/or inhaled steroids are permitted.
Any chronic medical condition requiring a higher dose of corticosteroid than mg prednisone/prednisolone daily; use of inhaled, intranasal, intra-articular and topical steroids is acceptable, as is a short course (i.e. =<  day) of corticosteroids to prevent a reaction to the IV contrast used for CT scans
Treatment with corticosteroids in the last -week period before inclusion, except for topical, ocular, intra-articular, intranasal, and inhaled corticosteroids with minimal systemic absorption (e.g. with a dose ?  microgram beclomethasone equivalent for inhaled steroids), or adrenal replacement steroid doses ?  mg daily prednisone equivalent which are permitted.
Treatment with any of the following medications within  days of registration, or while on study, is prohibited:\r\n* Systemic corticosteroids (at doses over the equivalent of  mg prednisone daily) - not permitted within  month of registration; inhaled, intranasal or topical corticosteroids are acceptable\r\n* Prostate cancer (PC)-SPES\r\n* Saw palmetto\r\n* Megestrol\r\n* Ketoconazole\r\n* -alpha-reductase inhibitors - patients already taking -alpha-reductase inhibitors prior to  days prior to registration may stay on these agents throughout the course of therapy, but these should not be started while patients are on study\r\n* Diethylstilbestrol\r\n* Abiraterone\r\n* Enzalutamide\r\n* Radium  (Xofigo)\r\n* Any other hormonal agent or supplement being used with the intent of cancer treatment
Patients must be off systemic immunosuppressive medications >  weeks prior to treatment start; if patients are in systemic corticosteroids and must be on a dose of prednisone  mg/day or less (or equivalent), then patients must be on this reduced dose for >  week prior to treatment start; topical steroids are allowed
Short course systemic corticosteroids for disease control, improvement of performance status or non-cancer indication (=<  days) must have been discontinued at least  days prior to study treatment; stable ongoing corticosteroid use (>=  days) up to an equivalent dose of  mg of prednisone is permissible\r\n* CTCL: Topical steroids that have been used for >  weeks may be continued\r\n* All other histologies (not CTCL): Topical steroids use is permissible without restriction
Ongoing immunosuppressive therapy, including systemic corticosteroids (>  mg prednisone or equivalent/day) with the exception of the use of topical, enteric, or inhaled corticosteroids as therapy for comorbid conditions and systemic steroids for autoimmune anemia and/or thrombocytopenia
Use of systemic corticosteroid therapy (except for replacement doses of glucocorticoid and/or mineralocorticoid for adrenal insufficiency); inhaled or intranasal corticosteroids for allergic or bronchospastic conditions are permitted
DOSE ESCALATION COHORT: Subjects who are receiving an immunosuppressive treatment for any reason, including chronic use of systemic steroid or prednisone equivalent at doses ?  mg/day within  days prior to the first dose of study treatment; use of inhaled or topical steroids or systemic corticosteroids <  mg is permitted
DOSE EXPANSION COHORT: Subjects who are receiving an immunosuppressive treatment for any reason, including chronic use of systemic steroid or prednisone equivalent at doses ?  mg/day within  days prior to the first dose of study treatment; use of inhaled or topical steroids or systemic corticosteroids <  mg is permitted
Systemic continuous corticosteroid therapy at a daily dose higher than  mg prednisone or equivalent is not allowed; patients may be using topical or inhaled corticosteroids
Immunosuppressive treatment that cannot be discontinued prior to study entry and for the duration of the study. Immunosuppressive treatment should be discontinued for at least  week prior to start of the administration of CPI-. Oral prednisone at a dose of mg or less per day is allowed, as are other oral corticosteroids given at glucocorticoid-equivalent doses. Topical, nasal and inhaled corticosteroids are also allowed
There is no limitation to prior treatments with local, regional, topical or systemic agents, except for prior systemic treatment with -fluorouracil or prodrugs thereof; prior topical treatment with -fluorouracil is permitted; patients who are on chronic daily doses of prednisone of greater than  mg are excluded; there is no restriction on timing of last treatments as long as patients have recovered from all expected toxicities and at least  days have passed since last administration
Active immunosuppressive therapy, including concurrent systemic immunosuppressive therapy or steroid therapy with more than  consecutive days of steroids within the prior  weeks\r\n* The use of prednisone or equivalent < . mg/kg/day (absolute maximum of  mg/day) as replacement therapy is permitted\r\n* Inhaled corticosteroids are permitted
Regular dose of corticosteroids the  days prior to Day  of this study or anticipated need for corticosteroids that exceeds prednisone  mg/day or equivalent within  days prior to the first RO infusion. Inhaled and topical steroids are permitted
Chronic treatment with corticosteroids or other immunosuppressive agents except (i) inhaled or topical steroids or replacement dose corticosteroids equivalent to ?  mg prednisone and (ii) patients receiving physiological doses of hydrocortisone for adrenal insufficiency
Immunosuppressive treatment that cannot be discontinued both prior to study entry and for the duration of the study. Oral prednisone at a dose of  mg or less per day is allowed, as are other oral corticosteroids given at glucocorticoid-equivalent doses. Topical, nasal and inhaled corticosteroids are also allowed.
Treatment with per oral systemic corticosteroids exceeding mg/day within seven () days before Screening until nephrectomy (inhaled, intranasal and local steroids accepted irrespective of dose)
Ongoing immunosuppressive therapy, including cyclosporine and tacrolimus; patients who are on high dose steroid; Note: Subjects may be using systemic corticosteroids (daily doses =<  mg of prednisone or equivalent) or topical or inhaled corticosteroids
Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent with the following exceptions:\r\n* Intermittent steroids (not to exceed  mg every day) may be used on an as-needed basis (e.g. treatment for chemotherapy-related nausea, anorexia and fatigue)\r\n* Patients on physiologic replacement doses of steroids due to adrenal insufficiency for any reason may remain on these medications\r\n* Topical, inhaled or intra-articular corticosteroids
Subjects receiving chronic, systemic treatment with corticosteroids equivalent to >  mg of prednisone per day; subjects receiving replacement for adrenal insufficiency will be allowed on the study; topical or inhaled corticosteroids are allowed
Concurrent treatment with anti -Tumor necrosis factor (TNF) alpha therapies, systemic corticosteroids (prednisone dose > mg per day or equivalent) or other immune suppressive drugs within the  weeks prior to Screening. Steroids that are topical, inhaled, nasal (spray), or ophthalmic solution are permitted
Patients who require pharmacological or replacement doses of systemic corticosteroids or who have received systemic corticosteroids within  days of study entry; use of topical, inhaled or ophthalmic steroids is permitted.
Short course systemic corticosteroids for disease control, improvement of performance status or non-cancer indication (=<  days) must have been discontinued at least  days prior to study treatment; stable ongoing corticosteroid use (>=  days) up to an equivalent dose of  mg of prednisone is permissible\r\n* Topical steroids that have been used for >  weeks may be continued (CTCL only)
Concurrent medical condition requiring the use of immunosuppressive medications or immunosuppressive doses of systemic or absorbable topical corticosteroids (doses greater than  mg/day prednisone or equivalent); inhaled or intranasal corticosteroids (with minimal systemic absorption) may be continued; non-absorbed intra-articular steroid injections are allowed; the exception to the use of steroids is the treatment of serious adverse events (SAEs) such as pneumonitis and the prevention of emesis
Treatment with any of the following medications or interventions concomitantly or within  days of starting ipilimumab: a) systemic corticosteroids; use of inhaled, intranasal, intra-articular and topical steroids is acceptable, as is a short course (i.e. =<  day) of corticosteroids to prevent a reaction to the IV contrast used for CT scans; b) external beam radiation therapy or major surgery requiring general anesthetic; c) any systemic therapy for prostate cancer (with the exception of bisphosphonates and receptor activator of nuclear factor kappa [RANK]-ligand inhibitors for bone metastases which are allowed) including chemotherapy, secondary hormonal therapies, (such as megestrol acetate, diethylstilbestrol, ketoconazole, abiraterone, enzalutamide) and non-steroidal anti-androgens (such as bicalutamide, flutamide or nilutamide); d) immune modulators, cytokines or vaccines for the management of cancer or non-cancer-related illnesses; e) any non-oncology vaccine therapy used for prevention of infectious diseases (for up to one month before any dose of ipilimumab); f) any other investigational product
Use of systemic corticosteroids equivalent to prednisone  mg/day or higher at the time of study entry (inhaled corticosteroids are permitted)
Concomitant use of the following medications\r\n* Any investigational anticancer therapy\r\n* Any concurrent chemotherapy, immunotherapy, or biologic therapy; concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable\r\n* Immunosuppressive medications including, but not limited to systemic corticosteroids (>  mg/day prednisone or equivalent), methotrexate, azathioprine, and tumor necrosis factor alpha (TNF-alpha) blockers; use of immunosuppressive medications for the management of investigational product-related adverse event (AE)s, in subjects with contrast allergies is acceptable; in addition, use of inhaled and intranasal corticosteroids is permitted
Subjects taking systemic corticosteroid therapy for any reason including replacement therapy for hypoadrenalism, are not eligible. Subjects receiving inhaled or topical corticosteroids are eligible. Decadron treatment with docetaxel is acceptable.
Treatment with any of the following medications within  days of registration, or while on study, is prohibited:\r\n* Systemic corticosteroids (at doses over the equivalent of  mg prednisone daily); inhaled, intranasal or topical corticosteroids are acceptable\r\n* Prostate cancer (PC)-SPES\r\n* Saw palmetto\r\n* Megestrol\r\n* Ketoconazole\r\n* -alpha-reductase inhibitors-patients already taking -alpha-reductase inhibitors prior to  days prior to registration may stay on these agents throughout the course of therapy, but these should not be started while patients are on study\r\n* Diethyl stilbestrol\r\n* Abiraterone\r\n* Any other hormonal agent or supplement being used with the intent of cancer treatment
Receiving chronic therapy for more than  days at doses of prednisone greater than  mg/day (or equivalent) at the moment of the inclusion. Inhaled and topical corticosteroids are allowed.
Patients receiving chronic systemic treatment with corticosteroids (dose of >=  mg/day methylprednisone equivalent) or another immunosuppressive agent; inhaled and topical steroids are acceptable
Treatment with an immunosuppressive regimen of corticosteroids or other immunosuppressive medication (e.g., methotrexate, rapamycin) within  days of study treatment; note: patients with adrenal insufficiency may take up to  mg of prednisone or equivalent daily; topical and inhaled corticosteroids in standard doses are allowed
Immunosuppressive treatment that cannot be discontinued both prior to study entry and for the duration of the study. Oral prednisone at a dose of  mg or less per day is allowed, as are other oral corticosteroids given at glucocorticoid-equivalent doses. Topical, nasal and inhaled corticosteroids are also allowed
Active immunosuppressive therapy associated with: Organ or allogeneic hematopoietic stem cell transplant, High-dose steroids, such as daily steroid doses in excess of  mg/day of prednisone (Note: Use of intra-articular or topical corticosteroids or eye drops containing corticosteroids is acceptable.), or Inhaled corticosteroids;
Patients who require chronic daily oral corticosteroid or other immunosuppressive therapy; topical or inhaled corticosteroids are permitted; also, a time limited course of steroids for an unrelated medical condition (e.g. allergic reaction, poison ivy) will not preclude receipt of immunotherapy provided that two weeks elapse between the last dose of systemic corticosteroids and initiation of immunotherapy
Patients who require chronic daily oral corticosteroid or other immunosuppressive therapy; topical or inhaled corticosteroids are permitted; also, a time limited course of steroids doses for an unrelated medical condition (e.g. allergic reaction, poison ivy) will not preclude receipt of immunotherapy provided that two weeks elapse between the last dose of systemic corticosteroids and initiation of immunotherapy
The patient requires concomitant treatment with systemic corticosteroids or any other immunosuppressive agents. The use of prednisone, or equivalent, <. mg/kg/day (absolute maximum  mg/day), or inhaled corticosteroids or topical steroids is permitted.
Concurrent treatment with systemic corticosteroids (prednisone dose >  mg per day or equivalent) or other immunosuppressive drugs <  days prior to treatment initiation; steroids that are topical, inhaled, nasal (spray), or ophthalmic solution are permitted
Has a history of a well-characterized and defined immune deficiency before the diagnosis of MF/SS or is receiving systemic steroid therapy greater than mg/day of prednisone or equivalent within  weeks or any other form of immunosuppressive therapy within  days before the first dose of trial treatment; the use of physiologic replacement doses of corticosteroids, along with topical, inhaled and local injection is discussed
Concurrent medical condition requiring the use of systemic immunosuppressive medications within  days before the first dose of study treatment. Physiologic doses of corticosteroids for treatment of endocrinopathies or steroids with minimal systemic absorption, including topical, inhaled, or intranasal corticosteroids may be continued if the subject is on a stable dose.
Concurrent treatment with anti-Tumor necrosis factor alpha (TNF alpha) therapies, systemic corticosteroids (prednisone dose greater than [>] mg per day or equivalent) or other immune suppressive drugs within the  weeks prior to Screening. Steroids that are topical, inhaled, nasal (spray) or ophthalmic solution are permitted
Use of any systemic oral or parenteral steroid containing medications is not permitted; use of High Daily Dose inhaled/intranasal corticosteroids is not permitted; use inhaled/intranasal corticosteroid preparations at dosing levels less than High Daily Dose is permitted
. Any concurrent condition requiring the continued or anticipated use of systemic steroids (excluding non-systemic inhaled, topical skin and/or eye drop-containing corticosteroids) or immunosuppressive therapy (excludes low dose methotrexate). All other systemic corticosteroids must be discontinued at least  weeks prior to first Study Treatment;
Immunosuppressive treatment that cannot be discontinued both prior to study entry and for the duration of the study. Oral prednisone at a dose of  mg or less per day is allowed, as are other oral corticosteroids given at glucocorticoid-equivalent doses. Topical, nasal and inhaled corticosteroids are also allowed
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone greater than or equal to  mg/day, or equivalent. Inhaled and topical steroids are allowed
Intranasal, inhaled, topical, intra-articular, and ocular corticosteroids with minimal systemic absorption are permitted.