Overview

Rituximab Therapy for Steroid-Refractory Chronic Graft Versus Host Disease

Status:
Completed
Trial end date:
2010-11-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborator:
Brigham and Women's Hospital
Treatments:
Rituximab
Criteria
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