B-Chronic Lymphocytic Leukemia Clinical Trial
Official title:
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
Rationale: Research indicates that both cyclophosphamide and pentostatin work
synergistically against cancer cells and have a high response rate against chronic
lymphocytic leukemia (CLL) without creating severe side effects in patients. In addition,
studies have shown that rituximab, a therapy that targets the immune system, has the highest
efficacy against CLL and the lowest toxicity rate when compared with other immunotherapy
drugs. Studies also show that rituximab enhances the efficacy of the chemotherapy agents
cyclophosphamide and pentostatin. This study offers the combination of immunotherapy with
two promising chemotherapy agents against CLL.
Purpose: This study is evaluating the efficacy and safety of combination treatment with
cyclophosphamide, pentostatin, and rituximab in patients with CLL. Several tests evaluating
the genetic and molecular components of CLL will also be performed. Some of these tests will
be conducted before, during, and after treatments to assess changes resulting from the study
drugs. Each patient's outcome will be assessed in relation to various aspects of their
genes.
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