Any corticosteroid therapy for indications other than GVHD at doses >  mg/kg per day methylprednisolone (or prednisone equivalent) within  days of randomization.
Participants who received greater than  days of corticosteroids in the preceding  days prior to enrollment; physiologic dosing of steroid is - mg/m^/day prednisone, .-. mg/kg/day dexamethasone, or .-. mg/kg/day hydrocortisone; contact the AMC Protocol Team for physiologic dosing limits for other corticosteroids
Daily steroids of > . mg/kg prednisone or glucocorticoid equivalent, methotrexate, or extracorporeal photopheresis
Participants must have steroid refractory cGVHD, defined as having persistent signs and symptoms of chronic GVHD despite the use of prednisone at >= .  mg/kg/day (or equivalent) for at least  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 >= . mg/kg/day (or . mg/kg every other day) for at least  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 >  mg/kg/day (or equivalent)
Use of systemic corticosteroids >. mg/kg/day within  days prior to obtaining  mL whole blood starting material.
A lack of response or disease progression after administration of minimum prednisone  mg/kg/day for at least  week, OR
Disease persistence without improvement despite continued treatment with prednisone at > . mg/kg/day or  mg/kg/every other day for at least  weeks, OR
Increase to prednisolone dose to > . mg/kg/day after  unsuccessful attempts to taper the dose
Any corticosteroid therapy for indications other than cGvHD at doses >  mg/kg/day methylprednisolone or equivalent within  days of Cycle  Day 
EXCLUSION - INFUSION: Current use of systemic corticosteroids > . mg/kg/day
TREATMENT EXCLUSION: Current use of systemic corticosteroids at a dose equivalent to . mg/kg/day of prednisone or higher
Use of systemic corticosteroids > . mg/kg/day prednisolone or equivalent does of alternative corticosteroid within  days prior to obtaining  mL starting material
Doses ?  mg/kg/day prednisolone or equivalent is allowed, provided that the steroid dose has been stable or tapering for at least  days prior to the first dose of CUDC-.
Currently taking corticosteroids (> . mg/kg/day prednisone or equivalent)
Currently taking corticosteroids (> . mg/kg/day prednisone or equivalent)
Subjects who received any corticosteroid therapy (for non-GVHD) at doses >. mg/kg/day prednisone (or equivalent) within  days prior to the onset of GVHD therapy.
Must have one of the following diagnoses:\r\n* Acute GVHD (grade II-IV) requiring systemic therapy and refractory/unresponsive to glucocorticoid (>=  mg prednisone-equivalent/kg x  week)\r\n* Chronic GVHD that is extensive and not improved despite therapy with glucocorticoid (>= . mg prednisone-equivalent/kg/day) and therapeutic doses of a calcineurin inhibitor for at least  weeks, or worsened within  weeks, or overlap syndrome not responding to glucocorticoid treatment (>=  mg prednisone-equivalent/kg x  week)
Current use of systemic corticosteroids > . mg/kg/day
Currently taking corticosteroids (> . mg/kg/day prednisone or equivalent) for therapy of GVHD
TREATMENT WITH SJCAR: Receiving systemic steroids therapy exceeding the equivalent of . mg/kg/day of methylprednisolone, in the  days prior to CAR T-cell infusion
Inability to begin a prednisone dose ?. mg/kg/d for the treatment of cGVHD
Patients on corticosteroids > . mg/Kg/day (i.e. > the maximum dose of mg/day)
Has undergone RIC allo BMT: cyclophosphamide (. mg/kg/day) days ? and ?, fludarabine ( mg/m/day) days ? through ?, total body irradiation ( cGy) day ?, day  infusion of an unmanipulated bone marrow graft (target . x ^ nucleated cells/kg recipient ideal body\r\nweight), cyclophosphamide ( mg/kg) days + and +, mycophenolate mofetil days + through +, tacrolimus or sirolimus days + through days + based on protocol, and filgrastim ( mcg/kg/day) day + through neutrophil recovery (> /uLiter) following Hopkins BMT policy\r\nmanual guidelines
Participants must have steroid-refractory cGVHD, which is defined as having persistent signs and symptoms of cGVHD despite the use of prednisone at . mg/kg/day (or . mg/kg every other day) for at least  weeks (or equivalent dosing of alternate corticosteroids) without complete resolution of signs and symptoms
Stable dose of corticosteroids for  weeks prior to enrollment, i.e. the patients steroid dose (mg/kg) will remain unchanged (e.g. . mg/kg) in the  weeks preceding enrollment; allowances will be made for up or down titrating the dose based on changes in body weight
Confirmed diagnosis of steroid refractory aGvHD defined as patients administered high-dose systemic corticosteroids (methylprednisolone  mg/kg/day [or equivalent prednisone dose . mg/kg/day]), given alone or combined with calcineurin inhibitors (CNI) and either:
Requirement for an increase in the corticosteroid dose to methylprednisolone ? mg/kg/day (or equivalent prednisone dose ?. mg/kg/day) , OR
Failure to taper the methylprednisolone dose to <. mg/kg/day (or equivalent prednisone dose <. mg/kg/day) for a minimum  days.
Clinically significant and ongoing immune suppression including, but not limited to: systemic immunosuppressive agents such as cyclosporine or corticosteroids (at an equivalent dose of . mg prednisone/kg per day, or higher), chronic lymphocytic leukemia (CLL), uncontrolled human immunodeficiency virus (HIV) infection
Any concurrent treatment that would compromise the study including but not limited to continuous high dose corticosteroids (>.mg/kg), lymphodepleting antibodies or cytotoxic agents.
Clinical status at enrollment to allow tapering of steroids to less than . mg/kg/day of prednisone
If on corticosteroids, a dose of <  mg/kg prednisone per day or equivalent that has been stable for ?  days prior to the first dose of PRTX-. High-dose pulse steroid therapy is NOT allowed within  days prior to the first dose of PRTX-.
Concurrent use of corticosteroids equivalent of prednisone at a dose > . mg/kg
Failure to respond to corticosteroids, defined as:\r\n* Progression of chronic GVHD despite optimal first line therapy (> . mg/kg/day of prednisone dose equivalent [PDE] for two weeks) or\r\n* No improvement after - weeks of sustained therapy; sustained therapy should include  weeks of > . mg/kg/day of PDE or\r\n* Inability to taper steroid dosage to less than . 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
Clinical status at enrollment to allow tapering of steroids to equal or less than . mg/kg/day prednisone (or equivalent).
Clinical status at enrollment to allow tapering of steroids equal to or less than . mg/kg/day of prednisone
Clinical status to allow tapering of steroids to less than . mg/kg/day prednisone or equivalent
Patients requiring high doses of glucocorticosteroids (? . mg/kg prednisone or its equivalent)
Clinical status at enrollment to allow tapering of steroids to equal or less than . mg/kg/day prednisone (or equivalent)
Current use of systemic corticosteroids > . mg/kg/day
Underwent Autologous SCT - days prior to registration including:\r\n* BEAM conditioning (BCNU:  mg/m IV day -, Etoposide:  mg/m IV BID days -,-,-,-, Cytarabine:  mg/m IV BID days -,-,-,-, Melphalan:  mg/m IV day -)\r\n* Minimum of  x ^ CD+ cells/kg infused
Patients must have clinical aGvHD and pathologic findings consistent with the diagnosis by biopsy of at least  involved site and treated initially with steroids at prednisone-equivalent doses ? mg/kg/day, and i) worsening of GvHD manifestations across any interval of at least  days before tapering of steroid doses has begun, or ii) persistence of grade II to IV aGvHD across any interval of at least  days without improvement during steroid treatment at any prednisone-equivalent dose >. 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  days while tapering glucocorticoid treatment at any prednisone-equivalent dose >. 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).
Chronic or long-term corticosteroids: ?. mg/kg/day of oral prednisolone or equivalent
Sporadic corticosteroids: ? mg/kg/day of oral prednisolone or equivalent for  or more short courses of >  days
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  days on corticosteroids (>=  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  days on corticosteroids (>=  mg/kg of prednisone or equivalent)\r\n* Patients with protracted acute GvHD who are unable to be tapered below .mg/kg/d of prednisone (without the addition of alternate immunosuppressives) are considered eligible
Subjects with progressive GVHD (ie, increase in stage in any organ system or any new organ involvement) after  days of primary treatment with methylprednisolone ?  mg/kg per day (or equivalent).
Subjects with GVHD that has not improved (ie, decrease in stage in at least  involved organ system) after  days of primary treatment with methylprednisolone ?  mg/kg per day (or equivalent).
Subjects who previously began corticosteroid therapy at a lower dose (at least  mg/kg per day methylprednisolone) but develop new GVHD in another organ system.
Any corticosteroid therapy for indications other than GVHD at doses of methylprednisolone or equivalent >  mg/kg per day within  days of enrollment.
DONOR: Any contraindication to the administration of subcutaneous G-CSF at a dose of  mg/kg/day for  consecutive days
Any corticosteroid therapy (for indications other than GVHD) at doses >  mg/kg per day methylprednisolone or equivalent within  days of randomization.
Clinical status at enrollment to allow tapering of steroids to less than . mg/kg/day prednisone at time of treatment
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 >= . mg/kg/day (or . mg/kg every other day) for at least  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 >  mg/kg/day (or equivalent)
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 >= . mg/kg/day (or . mg/kg every other day) for at least  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 >  mg/kg/day (or equivalent)
Steroid refractory cGVHD, defined as having persistent signs and symptoms of cGVHD despite ?  weeks of prednisone (or equivalent) dosed at ? . mg/kg/day (or ? . mg/kg every other day) within the  months prior to screening.
Stable dose of ?  mg/kg/day of systemic prednisone or equivalent for at least  weeks prior to first dose of AMG .
Patients will be treated at the same dose of tremelimumab as they previously received; for patients on dose level  who had already satisfied criteria for escalation to  mg/kg they will be re-treated at mg/kg
Has cGvHD that did not respond to high-dose corticosteroids (average . mg/kg/d prednisone for >=  weeks) or second-line systemic therapy
Patients can be enrolled and begin study therapy with ofatumumab within  days from initiation of  mg/kg/day prednisone for therapy of chronic GVHD
Patients with chronic graft versus host disease (GVHD) that involves  or more organs or with a score of  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 . mg/kg/day (. mg/kg by mouth every other day) for at least  weeks\r\n* Refractory disease - Progressive cGVHD manifestations despite treatment with a glucocorticoid dose >= prednisone . mg/kg/day ( mg/kg by mouth every other day) for at least  weeks\r\n* Steroid intolerant
The patient requires treatment with corticosteroids at a dose > . mg/kg/day or has a known allergy to DSMO
Steroid dose not greater than  mg/kg prednisone equivalent at time of study enrollment; if patient has steroid refractory GVHD (defined as worsening of GVHD after  days of  mg/kg prednisone equivalent or no improvement after  days of  mg/kg prednisone equivalent), time interval from start of steroids to initiation of ECP should not be >  days
Inability to begin prednisone therapy at a dose of greater than . mg/kg/day.
Already receiving sirolimus (for prophylaxis or treatment of acute GVHD) with prednisone at ? . mg/kg/day (or equivalent)  additional agents.
Patients must have received a trial of corticosteroids equivalent to prednisone greater than or equal to . mg/kg/d for at least one month; OR at least one pulse of methylprednisolone at a dose at least  mg/d for  days on at least one occasion within the previous  months prior to the transplant decision
Patients must be tapered off systemic steroids to a dosage of less than or equal to . mg/kg/day
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          . Age ? and ? years of age.\n\n          . Recipient of an allogeneic hematopoietic stem cell transplantation.\n\n          . Steroid-resistant acute GvHD, Grade II-IV, defined as: progressive disease after \n             days of primary treatment with methylprednisolone  mg/kg, or equivalent; or lack of\n             at least a partial response after  days of primary treatment with methylprednisolone\n              mg/kg or equivalent; or lack of a complete response after  days of primary\n             treatment with methylprednisolone  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          . Evidence of myeloid engraftment (absolute neutrophil count ?. x E/L).\n\n          . Karnofsky Performance Status score ?%.\n\n          . Adequate renal function as defined by serum creatinine ?  ULN or calculated CrCl of\n             ? mL/min using the Cockroft-Gault equation: Calculated CrCl= ([-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  to  days of treatment with methylprednisolone  milligram per kilogram (mg/kg) or equivalent or lack of a CR after  days of primary treatment with methylprednisolone  mg/kg or equivalent. Note that participants who develop intestinal GvHD while receiving systemic therapy for other GvHD are still eligible after  to  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  mg/kg to  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.
Patients with steroid refractory graft versus host disease (SRGvHD). SRGvHD is defined as progression (=increase in overall grade) after  days on ?mg/kg methylprednisolone or equivalent OR no improvement (no decrease in overall grade) after  days on ? mg/kg methylprednisolone or equivalent. If patients are receiving steroids for GvHD prophylaxis as per center standard, progression after  days and no response after  days after doubling the steroid dose will be regarded as steroid refractory.
For Post-allo Part B: Concurrent use of corticosteroids equivalent of prednisone at a dose of greater than . mg/kg
Receiving a new course of systemic corticosteroids (? . mg/kg/day) as first-line cGVHD therapy at least  day and no more than  days prior to first dose of ENTO/Placebo AND
Inability to begin systemic corticosteroids therapy at a dose of ? . mg/kg/day (or equivalent)
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  days, or no improvement within  consecutive days, of treatment with  mg/kg/day methylprednisolone or equivalent.
Clinical status at enrollment to allow tapering of steroids to equal or less than . mg/kg/day prednisone (or equivalent).
Clinical status at enrollment to allow tapering of steroids to less than . mg/kg/day prednisone
Daily steroids of > . mg/kg prednisone or glucocorticoid equivalent, methotrexate, or extracorporeal photopheresis
ELIGIBILITY FOR . MG/KG DOSING IN THE NEW COHORT
Patients must be undergoing a myeloablative allogeneic hematopoietic cell transplant with one of the following conditioning regimens:\r\n* Busulfan (>= . mg/kg IV or PO) and cyclophosphamide (>=  mg/kg)\r\n* Total body irradiation (TBI) (>=  cGy) and etoposide ( mg/kg)\r\n* TBI (>=  cGy) and cyclophosphamide ( mg/kg)
Prednisone equivalent of > m/kg for treatment of GVHD prior to administration of ibrutinib
Chronic GVHD that did not respond to high-dose corticosteroids (prednisone at . mg/kg/day for at least  week or prednisone at . mg/kg/day or  mg/kg every other day for at least  weeks), or second-line therapy (any)
Steroid-Refractory/Dependent aGVHD (ARM )\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  days of systemic corticosteroids of at least  mg/kg prednisone or equivalent\r\n** Progression of acute GVHD within  days of systemic corticosteroids of at least  mg/kg prednisone or equivalent\r\n** Failure to improve to at least grade II acute GVHD after  days of systemic corticosteroids, with initial doses of at least  mg/kg prednisone or equivalent\r\n** Flare of acute GVHD of at least grade II/IV severity while on steroids at a dose > ./mg/kg/day; this can include late-onset aGVHD and overlap syndrome
Patients requiring high doses of glucocorticosteroids (>= . mg/kg prednisone or its equivalent)
Steroid dependent/refractory cGVHD defined as:\r\n* Steroid dependent disease: Persistent cGVHD manifestations requiring a glucocorticoid dose >= prednisone . mg/kg/day (. mg/kg orally [po] every other day) for at least  weeks\r\n* Steroid refractory disease: Progressive cGVHD manifestations despite treatment with a glucocorticoid dose >= prednisone . mg/kg/day ( mg/kg po every other day) for at least  weeks
Patients must have steroid refractory chronic (c) GVHD, defined as having persistent signs and symptoms of chronic GVHD despite the use of prednisone at >= . mg/kg/day (or . mg/kg every other day) for at least  weeks in the preceding  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 patients best interest
Ongoing prednisone requirement >  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 >= . mg/kg/day (or . mg/kg every other day) for at least  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 >  mg/kg/day (or equivalent)
Acute GVHD must be corticosteroid refractory as defined by:\r\n* Progressive GVHD after at least  days on corticosteroids (>=  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  days on corticosteroids (>=  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 . mg/kg/day of prednisone equivalent or, in the opinion of the treating physician, requires addition of another systemic agent
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 >= . mg/kg/day (or . mg/kg every other day) for at least  weeks in the preceding  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 patients best interests; note that the dose of systemic steroids can certainly be lower than . mg/kg/day at enrollment
Ongoing prednisone requirement >  mg/kg/day (or equivalent)
Clinical status at enrollment to allow tapering of steroids to less than . mg/kg/day prednisone
Patients who have not shown a satisfactory response to methylprednisolone-equivalent doses at  mg/kg/day, based on adjusted body weight
Subjects will be eligible if their planned conditioning regimen for allogeneic HCT consists of one of the two following standard reduced intensity conditioning regimens:\r\n* FLU/MEL: fludarabine phosphate (fludarabine)  to  mg/m^; melphalan hydrochloride (melphalan) =<  mg/m^\r\n* FLU/BU: fludarabine  to  mg/m^; busulfan =<  mg/kg orally or =< . mg/kg intravenously
Patients with steroid refractory chronic GVHD are defined as having persistent signs and symptoms of chronic GVHD despite the use of prednisone at >= . mg/kg/day for at least  weeks in the preceding  months (or equivalent doses of alternate corticosteroids) without complete resolution of signs and symptoms