Phase II Trial of Pentostatin, and Rituximab With and Without Cyclophosphamide for Previously Untreated B-Chronic Lymphocytic Leukemia (CLL)
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
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the rate of complete and overall response using rituximab and pentostatin with and without cyclophosphamide.
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.
up to 5 years
Ohio State University
United States: Institutional Review Board
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