Alvocidib in Patients With Previously Treated Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia Arising From Chronic Lymphocytic Leukemia (CLL)
NCT ID: NCT00464633
Last Updated: 2013-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
165 participants
INTERVENTIONAL
2007-03-31
2011-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Alvocidib
Cycles with 4-week treatment with alvocidib followed by 2-week rest period for up to a maximum of 6 cycles
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient must have symptomatic and progressive disease;
* Patient must have received prior alkylating agent(s) and be fludarabine refractory;
* Patient must have the adequate organ functions;
* Patient's Eastern Cooperative Oncology Group performance (ECOG) status must be 0-2;
Exclusion Criteria
* Patient with secondary malignancy that will limit survival ≤5 years;
* Patient with prior allogenic or autologous bone marrow transplant or peripheral blood stem cell transplant ≤12 months;
* Patient receiving an investigational agent or an approved agent for an investigational purpose within last 4 weeks prior to study entry;
* Patient with known history of glucose-6-phosphate dehydrogenase deficiency;
* Patient with autoimmune hemolytic anemia;
* Patient with known Central Nervous System involvement;
* Patient with active, uncontrolled serious bacterial, viral or fungal infections
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Investigational Site Number 840008
San Diego, California, United States
Sanofi-Aventis Investigational Site Number 840022
San Francisco, California, United States
Sanofi-Aventis Investigational Site Number 840010
Chicago, Illinois, United States
Sanofi-Aventis Investigational Site Number 840012
Chicago, Illinois, United States
Sanofi-Aventis Investigational Site Number 840017
Indianapolis, Indiana, United States
Sanofi-Aventis Investigational Site Number 840001
Boston, Massachusetts, United States
Sanofi-Aventis Investigational Site Number 840023
Ann Arbor, Michigan, United States
Sanofi-Aventis Investigational Site Number 840005
New York, New York, United States
Sanofi-Aventis Investigational Site Number 840006
New York, New York, United States
Sanofi-Aventis Investigational Site Number 840003
Durham, North Carolina, United States
Sanofi-Aventis Investigational Site Number 840018
Cleveland, Ohio, United States
Sanofi-Aventis Investigational Site Number 840002
Columbus, Ohio, United States
Sanofi-Aventis Investigational Site Number 840020
Philadelphia, Pennsylvania, United States
Sanofi-Aventis Investigational Site Number 036001
St Leonards, , Australia
Sanofi-Aventis Investigational Site Number 056006
Bruges, , Belgium
Sanofi-Aventis Investigational Site Number 056001
Brussels, , Belgium
Sanofi-Aventis Investigational Site Number 056004
Ghent, , Belgium
Sanofi-Aventis Investigational Site Number 056003
Leuven, , Belgium
Sanofi-Aventis Investigational Site Number 056002
Yvoir, , Belgium
Sanofi-Aventis Investigational Site Number 250001
Paris, , France
Sanofi-Aventis Investigational Site Number 250003
Pierre-Bénite, , France
Sanofi-Aventis Investigational Site Number 250002
Tours, , France
Sanofi-Aventis Investigational Site Number 276001
Cologne, , Germany
Sanofi-Aventis Investigational Site Number 276004
Kiel, , Germany
Sanofi-Aventis Investigational Site Number 276002
Ulm, , Germany
Sanofi-Aventis Investigational Site Number 380002
Bologna, , Italy
Sanofi-Aventis Investigational Site Number 380001
Milan, , Italy
Sanofi-Aventis Investigational Site Number 528003
Amsterdam, , Netherlands
Sanofi-Aventis Investigational Site Number 528001
Groningen, , Netherlands
Sanofi-Aventis Investigational Site Number 528002
Rotterdam, , Netherlands
Sanofi-Aventis Investigational Site Number 630001
San Juan, , Puerto Rico
Sanofi-Aventis Investigational Site Number 826005
Aberdeen, , United Kingdom
Sanofi-Aventis Investigational Site Number 826002
Birmingham, , United Kingdom
Sanofi-Aventis Investigational Site Number 826004
Bournemouth, , United Kingdom
Countries
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Other Identifiers
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2006-006152-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EFC6663
Identifier Type: -
Identifier Source: org_study_id
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