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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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)
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
Secondary ID [1] 0 0
2006-006152-34
Secondary ID [2] 0 0
EFC6663
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia, Lymphocytic, Chronic 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Up to a maximum of 6 cycles
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Up to a maximum of 6 cycles
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Up to a maximum of 6 cycles
Secondary outcome [3] 0 0
Overall survival - Overall survival (OS) is defined as the time from the date of first administration of study drug to death.
Timepoint [3] 0 0
Up to a maximum of 6 cycles
Secondary outcome [4] 0 0
Overview of adverse events
Timepoint [4] 0 0
from study drug administration up to 30 days after last study drug administration

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;
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-Aventis Investigational Site Number 036001 - St Leonards
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
Belgium
State/province [10] 0 0
Brugge
Country [11] 0 0
Belgium
State/province [11] 0 0
Bruxelles
Country [12] 0 0
Belgium
State/province [12] 0 0
Gent
Country [13] 0 0
Belgium
State/province [13] 0 0
Leuven
Country [14] 0 0
Belgium
State/province [14] 0 0
Yvoir
Country [15] 0 0
France
State/province [15] 0 0
Paris Cedex 13
Country [16] 0 0
France
State/province [16] 0 0
Pierre Benite Cedex
Country [17] 0 0
France
State/province [17] 0 0
Tours
Country [18] 0 0
Germany
State/province [18] 0 0
Kiel
Country [19] 0 0
Germany
State/province [19] 0 0
Köln
Country [20] 0 0
Germany
State/province [20] 0 0
Ulm
Country [21] 0 0
Italy
State/province [21] 0 0
Bologna
Country [22] 0 0
Italy
State/province [22] 0 0
Milano
Country [23] 0 0
Netherlands
State/province [23] 0 0
Amsterdam
Country [24] 0 0
Netherlands
State/province [24] 0 0
Groningen
Country [25] 0 0
Netherlands
State/province [25] 0 0
Rotterdam
Country [26] 0 0
Puerto Rico
State/province [26] 0 0
San Juan
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Aberdeen
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Birmingham
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Bournemouth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00464633
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications