search
Back to results

Alvocidib in Patients With Previously Treated Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia Arising From Chronic Lymphocytic Leukemia (CLL)

Primary Purpose

Leukemia, Lymphocytic, Chronic

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
alvocidib
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, Lymphocytic, Chronic focused on measuring CLL, PLL, flavopiridol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

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.

Sites / Locations

  • Sanofi-Aventis Investigational Site Number 840008
  • Sanofi-Aventis Investigational Site Number 840022
  • Sanofi-Aventis Investigational Site Number 840010
  • Sanofi-Aventis Investigational Site Number 840012
  • Sanofi-Aventis Investigational Site Number 840017
  • Sanofi-Aventis Investigational Site Number 840001
  • Sanofi-Aventis Investigational Site Number 840023
  • Sanofi-Aventis Investigational Site Number 840005
  • Sanofi-Aventis Investigational Site Number 840006
  • Sanofi-Aventis Investigational Site Number 840003
  • Sanofi-Aventis Investigational Site Number 840018
  • Sanofi-Aventis Investigational Site Number 840002
  • Sanofi-Aventis Investigational Site Number 840020
  • Sanofi-Aventis Investigational Site Number 036001
  • Sanofi-Aventis Investigational Site Number 056006
  • Sanofi-Aventis Investigational Site Number 056001
  • Sanofi-Aventis Investigational Site Number 056004
  • Sanofi-Aventis Investigational Site Number 056003
  • Sanofi-Aventis Investigational Site Number 056002
  • Sanofi-Aventis Investigational Site Number 250001
  • Sanofi-Aventis Investigational Site Number 250003
  • Sanofi-Aventis Investigational Site Number 250002
  • Sanofi-Aventis Investigational Site Number 276004
  • Sanofi-Aventis Investigational Site Number 276001
  • Sanofi-Aventis Investigational Site Number 276002
  • Sanofi-Aventis Investigational Site Number 380002
  • Sanofi-Aventis Investigational Site Number 380001
  • Sanofi-Aventis Investigational Site Number 528003
  • Sanofi-Aventis Investigational Site Number 528001
  • Sanofi-Aventis Investigational Site Number 528002
  • Sanofi-Aventis Investigational Site Number 630001
  • Sanofi-Aventis Investigational Site Number 826005
  • Sanofi-Aventis Investigational Site Number 826002
  • Sanofi-Aventis Investigational Site Number 826004

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Alvocidib

Arm Description

Cycles with 4-week treatment with alvocidib followed by 2-week rest period for up to a maximum of 6 cycles

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Overall survival
Overall survival (OS) is defined as the time from the date of first administration of study drug to death.
Overview of adverse events

Full Information

First Posted
April 20, 2007
Last Updated
February 8, 2013
Sponsor
Sanofi
search

1. Study Identification

Unique Protocol Identification Number
NCT00464633
Brief Title
Alvocidib in Patients With Previously Treated Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia Arising From Chronic Lymphocytic Leukemia (CLL)
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphocytic, Chronic
Keywords
CLL, PLL, flavopiridol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alvocidib
Arm Type
Experimental
Arm Description
Cycles with 4-week treatment with alvocidib followed by 2-week rest period for up to a maximum of 6 cycles
Intervention Type
Drug
Intervention Name(s)
alvocidib
Other Intervention Name(s)
HMR1275
Intervention Description
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.
Primary Outcome Measure Information:
Title
Best overall objective response rate
Description
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
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
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
Title
Duration of objective response
Description
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
Title
Overall survival
Description
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
Title
Overview of adverse events
Time Frame
from study drug administration up to 30 days after last study drug administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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; 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Investigational Site Number 840008
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840022
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840010
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840012
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840017
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840001
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840023
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0759
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840005
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840006
City
New York
State/Province
New York
ZIP/Postal Code
10029-6574
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840003
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840018
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840002
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840020
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 036001
City
St Leonards
ZIP/Postal Code
2065
Country
Australia
Facility Name
Sanofi-Aventis Investigational Site Number 056006
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Sanofi-Aventis Investigational Site Number 056001
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Sanofi-Aventis Investigational Site Number 056004
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Sanofi-Aventis Investigational Site Number 056003
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Sanofi-Aventis Investigational Site Number 056002
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Sanofi-Aventis Investigational Site Number 250001
City
Paris Cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
Sanofi-Aventis Investigational Site Number 250003
City
Pierre Benite Cedex
ZIP/Postal Code
69495
Country
France
Facility Name
Sanofi-Aventis Investigational Site Number 250002
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Sanofi-Aventis Investigational Site Number 276004
City
Kiel
ZIP/Postal Code
24116
Country
Germany
Facility Name
Sanofi-Aventis Investigational Site Number 276001
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Sanofi-Aventis Investigational Site Number 276002
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Sanofi-Aventis Investigational Site Number 380002
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Sanofi-Aventis Investigational Site Number 380001
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Sanofi-Aventis Investigational Site Number 528003
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Sanofi-Aventis Investigational Site Number 528001
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Sanofi-Aventis Investigational Site Number 528002
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Sanofi-Aventis Investigational Site Number 630001
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
Facility Name
Sanofi-Aventis Investigational Site Number 826005
City
Aberdeen
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Sanofi-Aventis Investigational Site Number 826002
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Sanofi-Aventis Investigational Site Number 826004
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Alvocidib in Patients With Previously Treated Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia Arising From Chronic Lymphocytic Leukemia (CLL)

We'll reach out to this number within 24 hrs