Cyclophosphamide, Alvocidib, and Rituximab in Treating Patients With High Risk B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
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|ClinicalTrials.gov Identifier: NCT01076556|
Recruitment Status : Terminated
First Posted : February 26, 2010
Last Update Posted : November 11, 2015
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia Prolymphocytic Leukemia Recurrent Small Lymphocytic Lymphoma Refractory Chronic Lymphocytic Leukemia Stage I Chronic Lymphocytic Leukemia Stage I Small Lymphocytic Lymphoma Stage II Chronic Lymphocytic Leukemia Stage II Small Lymphocytic Lymphoma Stage III Chronic Lymphocytic Leukemia Stage III Small Lymphocytic Lymphoma Stage IV Chronic Lymphocytic Leukemia Stage IV Small Lymphocytic Lymphoma||Drug: Alvocidib Hydrochloride Drug: Cyclophosphamide Other: Diagnostic Laboratory Biomarker Analysis Other: Pharmacological Study Biological: Rituximab||Phase 1|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Feasibility Trial of Cyclophosphamide, Alvocidib (Flavopiridol) and Rituximab (CAR) in Patients With High Risk B-cell CLL/SLL|
|Study Start Date :||April 2010|
|Primary Completion Date :||July 2010|
Experimental: Treatment (rituximab, cyclophosphamide, 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).
Drug: Alvocidib Hydrochloride
Other Names:Drug: Cyclophosphamide
Other Names:Other: Diagnostic Laboratory Biomarker Analysis
Correlative studiesOther: Pharmacological Study
Correlative studiesBiological: Rituximab
- Maximum-tolerated dose of combination therapy with Cyclophosphamide, Alvocidib, and Rituximab [ Time Frame: 21 days ]Determined using the CTEP Active Version of the CTCAE.
- Treatment related adverse events assessed using the CTEP Active Version of the CTCAE [ Time Frame: Up to 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01076556
|United States, Ohio|
|Ohio State University Comprehensive Cancer Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Joseph Flynn||Ohio State University Comprehensive Cancer Center|