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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00464633
Registration number
NCT00464633
Ethics application status
Date submitted
20/04/2007
Date registered
23/04/2007
Date last updated
12/02/2013
Titles & IDs
Public title
Alvocidib in Patients With Previously Treated Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia Arising From Chronic Lymphocytic Leukemia (CLL)
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Scientific 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
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Secondary ID [1]
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2006-006152-34
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Secondary ID [2]
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EFC6663
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Leukemia, Lymphocytic, Chronic
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - alvocidib
Experimental: Alvocidib - Cycles with 4-week treatment with alvocidib followed by 2-week rest period for up to a maximum of 6 cycles
Treatment: Drugs: 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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Best overall objective response rate
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Assessment method [1]
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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.
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Timepoint [1]
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Up to a maximum of 6 cycles
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Secondary outcome [1]
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Progression-free survival
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Assessment method [1]
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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.
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Timepoint [1]
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Up to a maximum of 6 cycles
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Secondary outcome [2]
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Duration of objective response
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Assessment method [2]
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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.
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Timepoint [2]
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Up to a maximum of 6 cycles
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Secondary outcome [3]
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Overall survival
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Assessment method [3]
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Overall survival (OS) is defined as the time from the date of first administration of study drug to death.
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Timepoint [3]
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Up to a maximum of 6 cycles
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Secondary outcome [4]
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Overview of adverse events
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Assessment method [4]
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Timepoint [4]
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from study drug administration up to 30 days after last study drug administration
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Eligibility
Key inclusion criteria
- Patient must have documentation of histologically confirmed and measurable Chronic
Lymphocytic Leukemia (CLL) or Prolymphocytic Leukemia (PLL) arising from CLL;
- 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;
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Patient with de novo PLL;
- 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2011
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Sample size
Target
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Accrual to date
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Final
165
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Sanofi-Aventis Investigational Site Number 036001 - St Leonards
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Recruitment postcode(s) [1]
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2065 - St Leonards
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Recruitment outside Australia
Country [1]
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United States of America
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California
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Illinois
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Indiana
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Massachusetts
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Michigan
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New York
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United States of America
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North Carolina
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Ohio
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Pennsylvania
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Belgium
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Brugge
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Belgium
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Bruxelles
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Belgium
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Gent
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Belgium
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Leuven
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Belgium
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Yvoir
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France
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Paris Cedex 13
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France
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Pierre Benite Cedex
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France
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Tours
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Germany
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Kiel
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Germany
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Köln
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Germany
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Ulm
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Italy
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Bologna
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Italy
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Milano
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Netherlands
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Amsterdam
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Groningen
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Netherlands
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Rotterdam
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Puerto Rico
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San Juan
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United Kingdom
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Aberdeen
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United Kingdom
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Birmingham
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United Kingdom
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Bournemouth
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Sanofi
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00464633
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Sciences & Operations
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Address
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Sanofi
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00464633
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