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Phase II Trial of Pentostatin, and Rituximab With and Without Cyclophosphamide for Previously Untreated B-Chronic Lymphocytic Leukemia (CLL)
This study aims to assess the rate of complete and overall response using rituximab and pentostatin with and without cyclophosphamide, to monitor and assess toxicity of this regimen, and to determine the overall and progression-free survival in CLL patients
Details
| Lead sponsor | Ohio State University Comprehensive Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 28 |
| Start date | 2002-07 |
| Completion | 2006-09 |
Conditions
- B-Chronic Lymphocytic Leukemia
Interventions
- Pentostatin
- Rituximab
- Cyclophosphamide
Primary outcomes
- To assess the rate of complete and overall response using rituximab and pentostatin with and without cyclophosphamide. — up to 5 years
For this evaluation, patients will be classified as complete responders if either of the following types of response are documented * CCR (Clinically based complete remission) denotes NED (No Evidence of Disease) based on baseline clinical parameters. * CR denotes CCR and, in bone marrow, no nodules and \<30% lymphocytes.
Countries
United States