Status:
COMPLETED
Rituximab Therapy for Steroid-Refractory Chronic Graft Versus Host Disease
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Conditions:
Graft vs Host Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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).
Detailed Description
Patients will receive rituximab intravenously one time per week for four consecutive weeks. Once therapy is completed, the patient will have weekly visits with their physician for four more weeks, at ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00136396
Start Date
January 1 2004
End Date
November 1 2010
Last Update
June 12 2013
Active Locations (2)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115