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High Dose Cyclophosphamide and Rituximab in Low Grade and Mantle Cell Lymphoma
NCT00278161Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2005
- Primary completion
- Dec 2009
- Countries
- 1
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center
- Modality
- Small Molecules, Monoclonal Antibodies
- Conditions
- B-cell leukemia (BCL)non-Hodgkin lymphoma (NHL)mantle cell lymphoma (MCL)
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Overview
Phase 2, open-label, single-arm trial of rituximab and cyclophosphamide in B-cell leukemia (BCL), non-Hodgkin lymphoma (NHL) and mantle cell lymphoma (MCL), sponsored by Sidney Kimmel Comprehensive Cancer Center. Primary endpoints: Engraftment up to 43 days, Non-relapse Mortality at 5 years and 1 more. Started Jan 2005; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
R-HiCy
Rituximab and high-dose cyclophosphamide with pegfilgrastim support.
03
Who it enrols
Patients with B-cell leukemia, low-grade NHL, or mantle cell lymphoma with minimal bone marrow involvement, who have received prior cytotoxic therapy and achieved at least a partial response, with good organ function and performance status.
04
Endpoints
Primary
Engraftment
Non-relapse Mortality
Event-free Survival
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