Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Cancer Institute (NCI)
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
