Alvocidib in Patients With Previously Treated Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia Arising From Chronic Lymphocytic Leukemia (CLL)
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:
- to assess overall safety,
- to assess duration of response, progression free survival, and overall survival.
Clinical benefit and pharmacokinetics parameters are also evaluated.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicenter, Open-label, Single Arm Study of Weekly Alvocidib in Patients With Previously Treated B-Cell Chronic Lymphocytic Leukemia (CLL) or Prolymphocytic Leukemia (PLL) Arising From CLL|
- Best overall objective response rate [ Time Frame: Up to a maximum of 6 cycles ]
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.
- Progression-free survival [ Time Frame: Up to a maximum of 6 cycles ]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.
- Duration of objective response [ Time Frame: Up to a maximum of 6 cycles ]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.
- Overall survival [ Time Frame: Up to a maximum of 6 cycles ]Overall survival (OS) is defined as the time from the date of first administration of study drug to death.
- Overview of adverse events [ Time Frame: from study drug administration up to 30 days after last study drug administration ]
|Study Start Date:||March 2007|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Cycles with 4-week treatment with alvocidib followed by 2-week rest period for up to a maximum of 6 cycles
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:
Other Name: HMR1275
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00464633
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|Study Director:||Clinical Sciences & Operations||Sanofi|