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Randomized Phase II Trial of Pentostatin, Cyclophosphamide, and Rituximab With or Without Concurrent Avastin® for Previously Untreated B-Chronic Lymphocytic Leukemia (CLL)
RATIONALE: Drugs used in chemotherapy, such as pentostatin and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab and bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether giving pentostatin and cyclophosphamide together with rituximab is more effective with or without bevacizumab in treating patients with B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma. PURPOSE: This randomized phase II trial is studying the side effects of giving pentostatin and cyclophosphamide together with rituximab with or without bevacizumab and to see how well it works in treating patients with B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma.
Details
| Lead sponsor | Mayo Clinic |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 68 |
| Start date | 2009-02 |
| Completion | 2016-11-29 |
Conditions
- Leukemia
- Lymphoma
Interventions
- bevacizumab
- pegfilgrastim
- rituximab
- cyclophosphamide
- pentostatin
Primary outcomes
- Complete and Overall Response Rate — Evaluated after 6 cycles (up to 196 days)
A Complete Response (CR) requires all of the following for 2 months: * Absence of lymphadenopathy by physical examination (PE) * No hepato- or splenomegaly by PE * Neutrophils \>1500/ul, Platelets \>100,000/ul. Hemoglobin \>11.0 gm/dl, Peripheral blood lymphocytes \<4000/uL Nodular Partial Response (nPR) is defined as a patient qualified for a CR, but regenerative nodules are histologically present on bone marrow samples. A Clinical Complete Response (CCR) is defined as a patient qualified for a CR, but bone marrow samples are not available. A Partial Response (PR) requires 50% reduction in 2 of the following: peripheral blood lymphocytes, or the sum of the products of the maximal perpendicular diameters, or the size of liver and/or spleen; and a 50% increase in neutrophils, platelets, or hemoglobin. Overall response rate is calculated as the number of patients receiving CR, CCR, nPR, or PR as their objective status divided by the total number of evaluable patients.
Countries
United States