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