Please select the eligibility criteria that correspond to the clinical trial below.
Title: An Open Label, Phase I/II Trial of Rituximab Therapy for Steroid-Refractory Chronic Graft vs. Host Disease
Brief Summary: The purpose of this study is to determine if rituximab is a safe and effective therapy for steroid-refractory chronic graft versus host disease (GVHD).


Options:
A: Inclusion Criteria:

* Age greater than or equal to 2 years
* Prior allogeneic stem cell transplant, with any graft source, donor type, and GVHD prophylaxis allowed
* Clinical or histologic diagnosis of chronic GVHD (overlap syndrome with acute GVHD is allowed
* Need for systemic treatment, defined as any medication or intervention delivered systemically, including extracorporeal photopheresis. If a patient only received topical or local therapy at diagnosis, but subsequently requires systemic treatment, they may be enrolled upon initiation of systemic therapy. (Note, these patients will be classified as incident or prevalent cases depending on time from chronic GVHD diagnosis, not start of systemic therapy)
* If a prevalent case (defined as enrollment three or more months after chronic GVHD diagnosis), then subject must be within 2 years of stem cell infusion
* If an incident case (enrollment less than 3 months after chronic GVHD diagnosis) then no limitation on time from transplantation
* No evidence of primary disease relapseProgression-free for their malignancy at enrollment (no evidence of primary disease progression since transplant, although residual disease may still be present)
* Evaluation at the transplant center at the time of study enrollment
* Signed, informed consent and if applicable, child assent

Exclusion Criteria:

* Inability to comply with study procedures
* Anticipated survival less than 6 months due to co-morbid disease
B: Inclusion Criteria:

* Recipients of matched related, matched unrelated, or mismatched stem cell transplantation
* At least 180 days since allogeneic stem cell transplantation procedure
* Patients must have steroid-refractory chronic GVHD, defined as having persistent signs and symptoms despite the use of prednisone
* Stable dose of corticosteroids for 4 weeks prior to enrollment
* Adequate bone marrow function: absolute neutrophil count (ANC) \> 500/mm; platelets \> 20,000 ul
* Adequate renal function: creatinine \< 3.0 mg/dl
* Adequate hepatic function: bilirubin \< 3.0 mg/dl; AST \< 90 IU

Exclusion Criteria:

* Prednisone requirement greater than 2 mg/kg/day or equivalent
* Known life-threatening sensitivity to rituximab or other anti-B cell antibody.
* Prior exposure to any new immunosuppressive medication in the preceding 4 weeks prior to enrollment.
* Active, uncontrolled infection
* Evidence of natural exposure to hepatitis B or C.
* Active malignant disease relapse
* Donor lymphocyte infusion within the preceding 100 days.
* Life expectancy of less than 3 months.
* Pregnancy or lactation
* Evidence of HIV seropositivity
C: Inclusion Criteria:

To be eligible for inclusion in this trial, the patient must have moderate to severe chronic graft-versus-host disease \[defined by the National Institutes of Health (NIH) 2015 Consensus Criteria\] that started within 3 years after hematopoietic stem cell transplantation (HSCT).

Exclusion Criteria:

* Is intolerant to corticosteroids or hypersensitive to methoxsalen
* Received certain treatments during time periods disallowed by protocol
* Has infections and/or requires treatment that (per protocol or in the opinion of the investigator) might compromise:

  1. safety and well-being of participant or offspring
  2. safety of study staff
  3. analysis of results
D: Inclusion Criteria:

* Documented skin disease classical for chronic GvHD (e.g. hypopigmentation, hyperpigmentation, lichenoid lesions, sclerodermatous lesions)greater than or equal to 100 days post transplantation.
* Patients with documented chronic GvHD that is corticosteroid refractory, corticosteroid dependent or corticosteroid intolerant.
* Women of childbearing potential must agree to use a reliable method of birth control for the duration of this study.
* Patients must weight at least 40 kg (88 lbs.)

Exclusion Criteria:

* Active gastrointestinal bleeding
* Previous treatment with ECP
* Females who are pregnant and/or lactating

Answer: B