A Phase 2 interventional study of alvocidib in Leukemia, Lymphocytic, Chronic, sponsored by Sanofi. Completed at 34 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-12.
Sponsored by Sanofi · Phase 2, Interventional, and Treatment
Multicenter, open-label, study of alvocidib in previously treated chronic lymphocytic leukemia patients.
Primary objective is to determine overall response rate.
The secondary objectives are:
Clinical benefit and pharmacokinetics parameters are also evaluated.
Treatment until disease progression or no evidence of treatment response; occurrence of unacceptable toxicity, intercurrent medical problem, or adverse event (AE); or a maximum of 6 cycles.
Follow-up of 6 months after the last treatment with alvocidib.
The maximum duration of the study participation for patient will be about 15 months.
1,648 studies on the registry are indexed under Leukemia, Lymphocytic, Chronic, B-Cell; 245 are open to participants now.
This study's enrollment of 165 is above the median of 40 across 1,356 interventional studies indexed under Leukemia, Lymphocytic, Chronic, B-Cell.
Browse Leukemia, Lymphocytic, Chronic, B-Cell studies →Sanofi is the lead sponsor of 1,547 studies on the registry; 88 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 122 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Cycles with 4-week treatment with alvocidib followed by 2-week rest period for up to a maximum of 6 cycles
Drug: alvocidib
1st dose: 30 mg/m2 as a 30-minute intravenous (IV) infusion followed by 30 mg/m2 as a 4-hour continuous infusion Then, every treatment week, depending upon the patient's objective response to initial therapy: * 30 mg/m2 over 30 minutes followed by 50 mg/m2 over 4 hours or * 30 mg/m2 over 30 minutes followed by 30 mg/m2 over 4 hours.
Also known as: HMR1275
Best overall objective response rate
Objective Response Rate (ORR) is defined as the proportion of participants with complete response or partial response (including nodular partial response) relative to the total number of participants. Response assessment is based on evaluation of nodal disease by Computerized Tomography (CT) and National Cancer Institute Working Group 96 criteria (NCI-96) for assessment of liver, spleen, constitutional symptoms, peripheral blood (±) bone marrow.
Time frame: Up to a maximum of 6 cycles
Progression-free survival
Progression-free survival (PFS) is defined as the time from the date of first administration of study drug to the first documentation of progressive disease or death due to any cause in the absence of previous documentation of objective progression.
Time frame: Up to a maximum of 6 cycles
Duration of objective response
Duration of objective response is defined from the time of first occurrence of complete response or partial response (including nodular partial response) to the first documentation of progressive disease or death due to any cause in the absence of previous documentation of objective progression.
Time frame: Up to a maximum of 6 cycles
Overall survival
Overall survival (OS) is defined as the time from the date of first administration of study drug to death.
Time frame: Up to a maximum of 6 cycles
Overview of adverse events
Time frame: from study drug administration up to 30 days after last study drug administration
The record gives a start of Mar 2007, a primary completion of Dec 2011 and a completion of Dec 2011. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Alvocidib
Leukemia, Lymphocytic, Chronic, B-Cell →