Patients should not require concurrent therapeutic doses of steroids (> 20 mg of prednisone/day or equivalent) unless they need them for the indications; steroids should be discontinued for 14 days before starting protocol treatment
Requirement, at the time of study entry, for concurrent steroids > 10 mg/day of oral prednisone or the equivalent, except steroid inhaler, nasal spray or ophthalmic solution
Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of the trial treatment (with the exception of subjects with adrenal insufficiency, who may continue corticosteroids at physiologic replacement dose, equivalent to ? 10 mg prednisone daily). Note: Previous or ongoing administration of systemic steroids for the management of an acute allergic phenomenon is acceptable as long as it is anticipated that the administration of steroids will be completed in 14 days, or that the daily dose after 14 days will be ?10 mg per day of prednisone or equivalent.
Is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment\r\n* Physiologic doses of steroids (e.g. =< 10 mg prednisone/day or equivalent) are allowed; topical, inhaled, nasal and ophthalmic steroids are allowed
The use of systemic glucocorticoids in excess of 10 mg/day equivalent of prednisone is permitted provided it is not for the treatment of GVHD (e.g. chronic obstructive pulmonary disease, anti-emetic, infusion reactions). The chronic use of topical, inhaled, and locally injected steroids is permitted
Immunosuppressive doses of systemic medications, such as steroids or absorbed topical steroids (doses greater than 7.5 to 10 mg/day prednisone or equivalent) must be discontinued at least 2 weeks before study drug administration.
Subjects receiving immunologically based treatment for any reason, including chronic steroids or prednisone (at dose > 10 mg/day of prednisone) within 14 day prior to first study treatment; inhaled or topical steroids or systemic steroids (at dose =< 10 mg/day of prednisone) is permitted
Evidence of clinically significant immunosuppression such as the following:\r\n* Primary immunodeficiency state such as severe combined immunodeficiency disease\r\n* Concurrent opportunistic infection\r\n* Receiving systemic immunosuppressive therapy (> 2 weeks) including oral steroid doses > 10 mg/day of prednisone or equivalent within 2 months prior to enrollment; (steroids for pre-medication for imaging studies are allowed).
Subjects receiving prednisone or steroids must continue on the same dose they were receiving at the time of screening
Patients receiving systemic chronic steroid therapy or any immunosuppressive therapy (? 10mg/day prednisone or equivalent). Topical, inhaled, nasal and ophthalmic steroids are allowed.
Patients who are receiving additional immunosuppressive therapy or any steroids (except concurrent corticosteroid usage if no more than 20 mg per day, prednisolone equivalent is applied)
Patient may not have received prior systemic chemotherapy for LCH or other malignant disorder; systemic steroids equivalent to prednisone 1 mg/kg/day cannot have been given for more than 7 days in the 30 day period prior to study enrollment; however, patients who have only received surgical or radiation therapy, intralesional injection of steroids, or topical steroids may be enrolled
Systemic steroids that have not been stabilized to the equivalent of =< 10 mg/day prednisone prior to the start of the study drugs
Prior treated CNS metastases must be without MRI evidence of recurrence for at least 4 weeks after treatment; patients must be off immunosuppressive doses of systemic steroids (>= 10 mg/day prednisone or equivalent) for at least 14 days prior to study drug administration, and must have returned to neurologic baseline status postoperatively\r\n* The 4-week period of stability is measured after the completion of the neurologic interventions (ie, surgery and/or radiation)
In addition to neurosurgery to treat CNS metastases, adjuvant radiation after the resection of CNS metastasis is allowed; immunosuppressive doses of systemic steroids (doses > 10 mg/day prednisone or equivalent) must be discontinued at least 14 days before study drug administration
Patients that require decadron > 4 mg/ day or equivalent of steroids.
Patients may be on steroids prior to initiation of treatment, provided that, by cycle 1 day 1, steroid use is tapered down to less than or equal to 10 mg/day of prednisone
Require systemic pharmacologic doses of corticosteroids greater than the equivalent of 10 mg/day prednisone; topical, ophthalmologic and inhalational steroids are permitted. Subjects who have a history of adrenal insufficiency and are receiving greater than 10 mg/day prednisone may be eligible but only after Sponsor consultations. Subjects who are currently receiving steroids at a dose of ? 10 mg/day do not need to discontinue steroids prior to enrollment
Subjects with immunotherapy related adverse events requiring high doses of steroids (? 40 mg/day of prednisone) are not eligible.
Patients who require anticoagulation or systemic steroids at doses >10 mg daily of prednisone or equivalent or any immunosuppressive drugs. Beta-blocker therapy, while not exclusionary, is discouraged and alternatives should be sought if possible. The beta-blocker might compromise use of epinephrine for the rare possibility of anaphylaxis.
The treating physician expects that the patient will not require more than physiologic replacement dose of steroids defined as 32 mg of cortisone per day or its equivalent
Patients who take any immune or bone marrow suppressive agents including any systemic corticosteroid that exceed an equivalent of 10 mg prednisone per day within 2 weeks from the study treatment. Inhalation or topical steroids are allowed.
Patients may not receive ? 20 mg of prednisone or equivalent between days -7 and +28 of UCART123 infusion. Hydrocortisone required for mineralocorticoid replacement therapy is authorized at all times as needed clinically. Topical, inhaled, or nasal route of steroids are permitted;
Concurrent systemic steroid therapy if greater than the equivalent of 5 mg prednisone orally (PO) daily; patients previously on steroids must be off steroids for four weeks prior to treatment
Patients may not receive ? 20 mg of prednisone or equivalent between days -7 and +28 of UCART123 infusion. Hydrocortisone required for mineralocorticoid replacement therapy is authorized at all times as needed clinically. Topical, inhaled, or nasal route of steroids are permitted;
Asymptomatic off steroids for at least 10 days except patients: a) who have mild symptoms from intracranial disease that do not affect their performance status; or b) who are asymptomatic, but require steroids for control of symptoms on a maximum dose of dexamethasone 4mg/day orally (PO) or equivalent
Use of systemic chronic steroid therapy (?10mg /day of prednisone or equivalent), or any immunosuppressive therapy within 7 days of first dose of study treatment. Topical, inhaled, nasal, or ophthalmic steroids are allowed.
Not currently requiring systemic corticosteroid therapy (10 mg or less of prednisone or equivalent doses of other systemic steroids are allowed) or any other immune suppressive medications
Subject using chronic systemic steroids greater than the equivalent of 10 mg of prednisone/prednisolone per day in the 2 weeks preceding study entry; replacement doses of steroids, topical, inhalational, nasal and ophthalmic steroids are permitted
Patients may receive steroids to control symptoms related to central nervous system (CNS) involvement, but the dose must be =< 4 mg per 24 hours of dexamethasone (or the equivalent). Patient’s symptoms should experience stability of neurological symptoms for at least 7 days, or on tapering dose of steroids. Physiologic replacement doses for adrenal insufficiency is allowed on this protocol
No use of systemic steroids greater than the equivalent of 10 mg of prednisone/prednisolone per day within 4 weeks prior to enrollment
Patients with treated, non-progressive brain metastases, off high-dose steroids (>20 mg prednisone or equivalent) for at least 4 weeks can be enrolled in the trial.
Patients may be on steroids prior to initiation of treatment, provided that, by cycle 1 day 1, steroid use is tapered down to less than or equal to 20 mg/day of prednisone
Brain metastases that are clinically unstable (e.g. showing unequivocal growth on imaging, requiring radiation therapy, or steroids >10mg of prednisone equivalent) within 4 weeks of first dose of study drug.
No steroids are permitted within 28 days of C1D1; or doses < 10 mg/day prednisone equivalent or levels necessary for physiologic replacement
Patients who are on high-dose steroids (doses > 10 mg/day of prednisone or equivalent) or immune suppression medications; NOTE: Patients on high-dose steroids (doses > 10 mg/day of prednisone or equivalent) or immune suppression medications are eligible provided these drugs are discontinued at least 3 days prior to starting on the study drugs
Able to be off of corticosteroids (10 mg or less of prednisone or equivalent doses of other systemic steroids are allowed) and any other immune suppressive medications beginning on day -3
Patients may be on steroids prior to initiation of treatment, provided that, by cycle 1 day 1, steroids use was tapered down to less than or equal to 20 mg of prednisone
PRIOR TO LYMPHODEPLETION: Current use of systemic corticosteroids at doses ? 10 mg prednisone daily or its equivalent; those receiving < 10 mg daily may be enrolled at discretion of investigator; inhaled steroids are allowed\r\n* For pediatric patients, physiologic replacement hydrocortisone at doses 6-12 mg/m^2/day is allowed; equivalently dosed alternative steroids are allowed at discretion of investigator, though not to exceed 10mg prednisone per day; inhaled steroids are allowed
PRIOR TO INFUSION OF ATLCAR.CD30 CELLS: Current use of systemic corticosteroids at doses ? 10 mg prednisone daily or its equivalent; those receiving < 10 mg daily may be enrolled at discretion of investigator; inhaled steroids are allowed\r\n* For pediatric patients, physiologic replacement hydrocortisone at doses 6-12mg/m^2/day is allowed; equivalently dosed alternative steroids are allowed at discretion of investigator, though not to exceed 10mg prednisone per day; inhaled steroids are allowed
If patient is on steroids, patient must be on a stable or decreasing dose of steroids for 5 days, no more than 2 mg dexamethasone (or equivalent) total per day at the time of screening and consent; if on steroids at the time of screening, the dose will need to be tapered and discontinued at least 5 days prior to CMV T cell infusion
Steroids within 3 weeks prior to event 1, except:\r\n* =< 10 mg prednisone or equivalent per day\r\n* Steroid with little to no systemic absorption (ie, topical or inhaled steroids)
Patients who are on steroids (> 10 mg/day or equivalent) or immune suppression medications
At least 2 weeks from prior therapy to time of start of treatment; prior therapy includes steroids (except prednisone or equivalent - up to 10 mg per day is allowed)
Clinical status at enrollment to allow tapering of steroids to less than 0.5 mg/kg/day of prednisone
Patients who are on high dose steroid (> 10 mg daily of prednisone or equivalent) or immune suppression medications; Note: patients on high-dose steroids (doses > 10mg/day of prednisone or equivalent) or immune suppression medications are eligible provided these drugs are discontinued at least 3 days prior to starting on the study drugs
Patients receiving systemic steroids ? 10mg/day of prednisone or the equivalent
Clinical status at enrollment to allow tapering of steroids to equal or less than 0.5 mg/kg/day prednisone (or equivalent).
No autoimmune disease or chronic steroids (dose of > 10 mg/day prednisone equivalent) or other immunosuppressive medications within 7 days of randomization (for MSI-H nivolumab group)
Clinical status at enrollment to allow tapering of steroids equal to or less than 0.5 mg/kg/day of prednisone
Clinical status to allow tapering of steroids to less than 0.5 mg/kg/day prednisone or equivalent
Clinical status at enrollment to allow tapering of steroids to equal or less than 0.5 mg/kg/day prednisone (or equivalent)
Patients must be off systemic immunosuppressive medications > 2 weeks prior to treatment start; if patients are in systemic corticosteroids and must be on a dose of prednisone 5 mg/day or less (or equivalent), then patients must be on this reduced dose for > 1 week prior to treatment start; topical steroids are allowed
Systemic chronic steroid therapy (? 10mg/day prednisone or equivalent) or any immunosuppressive therapy 7 days prior to planned date for first dose of study treatment. Topical, inhaled, nasal and ophthalmic steroids are allowed.
?2 weeks for topical therapy (including steroids, retinoids, nitrogen mustard or imiquimod) Topical steroids (maximum strength: medium potency) and oral steroids (?10 mg prednisone equivalent/day) are allowed, if the patient has been on a stable dose with stable symptoms for at least 4 weeks prior to study entry.
Concomitant corticosteroid use, systemic or topical, for treatment of skin disease. However, topical steroids (maximum strength: medium potency) and oral steroids (?10 mg prednisone equivalent/day) are allowed, if patient has been on a stable dose with stable symptoms for at least 4 weeks prior to study entry.
Concurrent use of systemic steroids with the exception of chronically administered steroids equivalent to ? 10 mg/day prednisone if patient has been on this therapy for ?1month
Receiving systemic steroids exceeding 10 mg prednisone or equivalent, or unstable on steroid medication, during the 3 weeks immediately preceding enrollment
Dexamethasone at cumulative doses of greater than 160 mg or equivalent <3 weeks prior to study Day 1 is not allowed. Use of topical or inhaled steroids is acceptable
Patients receiving systemic steroids ? 10mg/day of prednisone or the equivalent
Previous autoimmune complication from PD-1 or PD-L1 requiring discontinuation of therapy or treatment with steroids (ongoing treatment with more than 10 mg of prednisone or steroid equivalent daily, excluding inhaled or topical steroids).
Patients must not be receiving concurrent steroids > 10 mg prednisone (or equivalent)\n             per day.
Immunosuppressive doses of systemic medications, such as steroids or absorbed topical steroids (doses > 10 mg/day prednisone or equivalent) must be discontinued at least 2 weeks before study drug administration
Immunosuppressive doses of systemic medications, such as steroids or absorbed topical steroids (doses > 10 mg/day prednisone or equivalent) must be discontinued at least 2 weeks before study drug administration
No systemic cytotoxic chemotherapy within 4 weeks of enrollment or systemic steroids (except stable doses of prednisone =< 20 mg/day, or up to 4 doses of steroid given for non-therapy reasons) within 4 weeks of enrollment
Steroids: Therapeutic systemic doses of steroids must be stopped > 72 hours prior to CTL019 infusion. However, the following physiological replacement doses of steroids are allowed: < 12 mg/m2/day hydrocortisone or equivalent
Steroids: Therapeutic doses of steroids must be stopped > 72 hours prior to CTL019 infusion. However, the following physiological replacement doses of steroids are allowed: < 6 - 12 mg/m2/day hydrocortisone or equivalent
Steroids: Therapeutic doses of steroids must be stopped > 72 hours prior to CTL019 infusion. However, the following physiological replacement doses of steroids are allowed: < 12 mg/m2/day hydrocortisone or equivalent
Subjects with Immunotherapy related adverse events requiring high doses of steroids (? 40 mg/day of prednisone) are not eligible
Concurrent systemic therapy with steroids or other immunosuppressive agents, or use of any investigational drug within 28 days before the start of trial treatment. Short-term administration of systemic steroids (that is, for allergic reactions or the management of immune-related adverse events [irAE]) while on study is allowed. Also, subjects requiring hormone replacement with corticosteroids for adrenal insufficiency are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses <= 10 mg or equivalent prednisone per day. Note: Subjects receiving bisphosphonate or denosumab are eligible.
Patients must not be receiving chronic treatment (equivalent of prednisone > 10 mg/day) with systemic steroids or other immuno-suppressive agent
Immunosuppressive doses of systemic medications, such as steroids or absorbed topical steroids (doses > 10 mg/day prednisone or equivalent) must be discontinued at least 2 weeks before study drug administration
Chronic oral or systemic steroid medication use at a dose of > 10 mg/d of prednisone or equivalent (steroids with low systemic absorption [e.g. triamcinolone hexacetonide] injected into joint space are allowed)
Clinical status at enrollment to allow tapering of steroids to less than 0.5 mg/kg/day prednisone at time of treatment
Patients requiring chronic treatment with systemic steroid therapy, other than replacement dose steroids or treatment with low, stable dose of steroid (<10 mg/day prednisone or equivalent) for stable CNS metastatic disease.
Steroids (at prednisone equivalent doses > 10 mg) are not permitted 3 days prior to T cell infusion and concurrently during therapy. Exceptions include use of systemic prednisone equivalent doses =< 10 mg/ day, topical steroids or physiologic replacement dose of steroids for adrenocortical deficiency.
Patients who are on high-dose steroids (doses > 10 mg/day of prednisone or equivalent) or immune suppression medications; Note: patients on high-dose steroids (doses > 10mg/day of prednisone or equivalent) or immune suppression medications are eligible provided these drugs are discontinued at least 3 days prior to starting on the study drugs
Patients must be on a stable or decreasing dose of corticosteroids for 5 days prior to enrollment; patient may be taking therapeutic doses of steroids during the initial dose escalations and prior to defining an RP2D; this should be recorded in the database; once the RP2D has been established, enrollment may be limited based on steroid use;*physiologic replacement doses will be defined on this protocol as no more than 0.75 mg/m^2/day of dexamethasone or equivalent of steroids; doses higher than this will be considered therapeutic
Patients who are on chronic steroids for unrelated conditions (i.e. rheumatologic conditions) are not eligible if their total daily dose of steroids is >= 10 mg prednisone
Ongoing treatment with chronic immunosuppressants (eg, cyclosporine) or systemic steroids > 20 mg prednisone (or equivalent) QD
No chronic use of systemic steroids greater than the equivalent of 10 mg of prednisone/prednisolone per day within 4 weeks prior to enrollment
Use of systemic steroids at an equivalent dose of prednisone 5 mg/day or higher at randomization
Systemic steroids that have not been stabilized to the equivalent of =< 10 mg/day of prednisone 7 days prior to the initiation of the trial
Chronic systemic steroids (>10 mg/day Prednisone equivalents) or any other immunosuppressive agents
Short term (<30 days) concurrent systemic steroids ?0.25 mg/kg prednisone per day (maximum 7.5 mg/day) and bronchodilators (inhaled steroids) are permitted; other steroid regimens and/or immunosuppressives are excluded while receiving vaccine. Patients requiring steroids following previous CNS radiation for metastatic disease are excluded.
Patients must be tapered off systemic steroids to a dosage of less than or equal to 0.25 mg/kg/day
Any condition requiring chronic use of moderate/high dose steroids (equivalent to 10 mg QD prednisone).
Immunosuppressive doses of systemic medication, such as steroids or absorbed topical steroids (doses > 10 mg/day prednisone or equivalent) must be discontinued at least 14 days prior to nivolumab administration
Concurrent use of other anti-cancer agents or treatments. NOTE: Growth factors and bisphosphonates are allowed as medically indicated. Steroids may be used with an equivalency of up to 20 mg of Prednisone per day as long as the dose has not been adjusted upwards in past 2 weeks prior to study registration.
Clinical status at enrollment to allow tapering of steroids to equal or less than 0.5 mg/kg/day prednisone (or equivalent).
Prior treated CNS metastases must be without MRI evidence of recurrence for at least 4 weeks after treatment. Patients must be off immunosuppressive doses of systemic steroids (? 10 mg/day prednisone or equivalent) for at least 14 days prior to study drug administration, and must have returned to neurologic baseline status postoperatively. • The 4-week period of stability is measured after the completion of the neurologic interventions (ie, surgery and/or radiation).
In addition to neurosurgery to treat CNS metastases, adjuvant radiation after the resection of CNS metastasis is allowed. Immunosuppressive doses of systemic steroids (doses ? 10 mg/day prednisone or equivalent) must be discontinued at least 14 days before study drug administration.
Clinical status at enrollment to allow tapering of steroids to less than 0.5 mg/kg/day prednisone
Treatment with oral steroids (dose ? 10 mg/day of methylprednisolone or equivalent)
Requirement, at time of study entry, for concurrent steroids > 10 mg/day of oral prednisone or the equivalent, except steroid inhaler, nasal spray, or ophthalmic solution
Patients who are on chronic steroids for unrelated conditions (i.e. rheumatologic conditions) are not eligible if their total daily dose of steroids is equivalent to greater than 10 mg prednisone
Use of systemic steroids at an equivalent dose of prednisone 5 mg/day or higher within 6 weeks of day 1 of protocol therapy
Patients may be on steroids prior to initiation of treatment as long as by cycle 1 day 1 steroids use was tapered down less than or equal to 20 mg of prednisone
Patients who are on high-dose steroids (doses > 10 mg/day of prednisone or equivalent) or immune suppression medications; Note: patients on high-dose steroids (doses > 10mg/day of prednisone or equivalent) or immune suppression medications are eligible provided these drugs are discontinued at least 3 days prior to starting on the study drugs
Clinical status at enrollment to allow tapering of steroids to less than 0.5 mg/kg/day prednisone
Chronic use of steroids at immunosuppressive doses. (Note, physiologic replacement doses of glucocorticoid or mineralocorticoid are acceptable, eg. prednisone 5-10 mg/day; fludrocortisone 0.1-0.2 mg/day)
Require, at the time of study entry, treatment with steroids > 10 mg/day of oral prednisone (or equivalent), except topical use, steroid inhaler, nasal spray or ophthalmic solution
Systemic steroids at physiologic doses (equivalent to dose of oral prednisone 10 mg) are permitted. Steroids as anti-emetics for chemotherapy are not allowed.
Subjects with a condition with anticipated use of systemic steroids above the equivalent of 10 mg prednisone are excluded.
Require systemic pharmacologic doses of corticosteroids at or above the equivalent of 10 mg/d prednisone; replacement doses, topical, ophthalmologic and inhalational steroids are permitted. Subjects who have a history of adrenal insufficiency and are receiving greater than 10 mg/day systemic steroids may be eligible but only after Sponsor consultation.