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:

* 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
D: DISEASE CHARACTERISTICS:

* Newly diagnosed chronic-graft-versus host disease (GVHD)
* Systemic immunosuppressive treatment indicated AND no contraindication to treatment with mycophenolate mofetil
* Has undergone prior transplantation with any type of donor, hematopoietic stem cell graft, or conditioning regimen
* No clinical, laboratory, or image-based evidence known to be present at the time of enrollment and indicating a high probability of subsequent recurrent or progressive disease

PATIENT CHARACTERISTICS:

Age

* Any age

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Absolute neutrophil count ≥ 1,500/mm\^3

Hepatic

* Not specified

Renal

* Not specified

Pulmonary

* No known bronchiolitis obliterans as a manifestation of chronic GVHD

Immunologic

* No fungal infection without radiographic evidence of improvement during continued antifungal therapy
* No cytomegalovirus (CMV) pneumonia without major radiographic evidence of improvement
* No other CMV infection without reduction of antigenemia or viral load during continued antiviral therapy
* No active disseminated varicella zoster viral infection
* No known hypersensitivity or allergy to MMF

Gastrointestinal

* Able to tolerate oral medication
* No lactose-intolerant children who are too young to swallow capsules
* No frank blood from the rectum
* No melena
* No known gastrointestinal ulceration

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

  * Female patients must use 2 forms of contraception 4 weeks prior to, during, and for 6 weeks after completion of study treatment
* Not hospitalized at time of enrollment
* No rare, hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT)

PRIOR CONCURRENT THERAPY:

Biologic therapy

* See Disease Characteristics

Chemotherapy

* Not specified

Endocrine therapy

* Prior treatment with prednisone or equivalent allowed provided the dose was ≤ 1.0 mg/kg/day at the time of enrollment
* Concurrent systemic glucocorticoids allowed

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* Prior mycophenolate mofetil (MMF) for prevention or treatment of acute GVHD allowed provided MMF was discontinued at least 2 weeks before the diagnosis of chronic GVHD was made
* No prior systemic treatment for chronic GVHD
* No prior treatment for chronic GVHD
* Concurrent antacids allowed provided there is at least a 2-hour interval before and after administration of MMF
* No other concurrent systemic immunosuppressive treatment except cyclosporine, tacrolimus or sirolimus

Answer: B