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Allogeneic Stem Cell Transplantation for Mantle Cell Lymphoma
NCT00006747Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2000
- Primary completion
- Feb 2003
- Countries
- 1
- Sponsor
- Cancer and Leukemia Group B
- Modality
- Small Molecules
- Conditions
- mantle cell lymphoma (MCL)
01
Overview
Phase 2, open-label, single-arm trial of carmustine, etoposide, cytarabine and melphalan in mantle cell lymphoma (MCL), sponsored by Cancer and Leukemia Group B. Primary endpoint: disease free survival at 5 years. Started Nov 2000; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Chemotherapy + Stem Cell Transplantation
Patients receive a conditioning regimen of carmustine, etoposide, cytarabine, and melphalan, followed by allogeneic peripheral blood stem cell transplantation, with GVHD prophylaxis and supportive care.
03
Who it enrols
Patients under 60 with histologically documented mantle cell lymphoma who have either failed initial therapy or are in first remission with poor prognostic characteristics. Patients must not have active CNS lymphoma, significant pulmonary disease, or HIV. Specific lab values for bilirubin, AST, ALT, and creatinine are required. Women of childbearing potential must not be pregnant or nursing and must use effective birth control.
04
Endpoints
Primary
disease free survival
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