Chronic Lymphocytic Leukemia Clinical Trial
Official title:
A Phase I Feasibility Trial of Cyclophosphamide, Alvocidib (Flavopiridol) and Rituximab (CAR) in Patients With High Risk B-cell CLL/SLL
This phase I trial is studying the side effects and the best dose of alvocidib when given together with cyclophosphamide and rituximab in treating patients with high risk B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Alvocidib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can also block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Other find cancer cells and help kill them or carry cancer-killing substances to them. Giving cyclophosphamide, alvocidib, and rituximab together may kill more cancer cells.
PRIMARY OBJECTIVES:
I. To determine the dose-limiting toxicity and maximum-tolerated dose of treatment with
cyclophosphamide, alvocidib, and rituximab in patients with high-risk B-cell chronic
lymphocytic leukemia or small lymphocytic lymphoma.
II. To determine the feasibility of administering this regimen as an outpatient regimen in
these patients.
SECONDARY OBJECTIVES:
I. To determine the complete response rate, partial response rate, and minimal-residual
disease-negative response rate in patients treated with this regimen.
II. To determine the pharmacokinetics of alvocidib and dexamethasone as part of this
regimen.
III. To determine the immunologic effects of this regimen as measured by serial T-cell and
NK-cell number, T-cell function, and immunoglobulin levels.
OUTLINE: This is a dose-escalation study of alvocidib.
Patients receive rituximab IV over 4 hours on days 1 (days 1-3 in course 1),
cyclophosphamide IV over 30-60 minutes on days 1-3, and alvocidib IV over 4.5 hours on days
1 and 8 (day 8 only in course 1). Treatment repeats every 21 days for 6 courses in the
absence of disease progression or unacceptable toxicity. Blood samples are collected
periodically for pharmacokinetic and pharmacodynamic studies.
After completion of study treatment, patients are followed up for up to 5 years.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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