A Phase I Feasibility Trial of Cyclophosphamide, Alvocidib (Flavopiridol) and Rituximab (CAR) in Patients With High Risk B-cell CLL/SLL
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
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
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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Treatment related adverse events assessed using the CTEP Active Version of the CTCAE
Up to 5 years
Ohio State University
United States: Food and Drug Administration
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