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

February 8, 2013 updated by: Sanofi

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

165

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • St Leonards, Australia, 2065
        • Sanofi-Aventis Investigational Site Number 036001
  • Belgium
      • Brugge, Belgium, 8000
        • Sanofi-Aventis Investigational Site Number 056006
      • Bruxelles, Belgium, 1000
        • Sanofi-Aventis Investigational Site Number 056001
      • Gent, Belgium, 9000
        • Sanofi-Aventis Investigational Site Number 056004
      • Leuven, Belgium, 3000
        • Sanofi-Aventis Investigational Site Number 056003
      • Yvoir, Belgium, 5530
        • Sanofi-Aventis Investigational Site Number 056002
  • France
      • Paris Cedex 13, France, 75651
        • Sanofi-Aventis Investigational Site Number 250001
      • Pierre Benite Cedex, France, 69495
        • Sanofi-Aventis Investigational Site Number 250003
      • Tours, France, 37044
        • Sanofi-Aventis Investigational Site Number 250002
  • Germany
      • Kiel, Germany, 24116
        • Sanofi-Aventis Investigational Site Number 276004
      • Köln, Germany, 50937
        • Sanofi-Aventis Investigational Site Number 276001
      • Ulm, Germany, 89081
        • Sanofi-Aventis Investigational Site Number 276002
  • Italy
      • Bologna, Italy, 40138
        • Sanofi-Aventis Investigational Site Number 380002
      • Milano, Italy, 20132
        • Sanofi-Aventis Investigational Site Number 380001
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • Sanofi-Aventis Investigational Site Number 528003
      • Groningen, Netherlands, 9713 GZ
        • Sanofi-Aventis Investigational Site Number 528001
      • Rotterdam, Netherlands, 3015 CE
        • Sanofi-Aventis Investigational Site Number 528002
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Sanofi-Aventis Investigational Site Number 630001
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • Sanofi-Aventis Investigational Site Number 826005
      • Birmingham, United Kingdom, B9 5SS
        • Sanofi-Aventis Investigational Site Number 826002
      • Bournemouth, United Kingdom, BH7 7DW
        • Sanofi-Aventis Investigational Site Number 826004
  • United States
    • California
      • San Diego, California, United States, 92103
        • Sanofi-Aventis Investigational Site Number 840008
      • San Francisco, California, United States, 94143
        • Sanofi-Aventis Investigational Site Number 840022
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Sanofi-Aventis Investigational Site Number 840010
      • Chicago, Illinois, United States, 60637
        • Sanofi-Aventis Investigational Site Number 840012
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Sanofi-Aventis Investigational Site Number 840017
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Sanofi-Aventis Investigational Site Number 840001
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0759
        • Sanofi-Aventis Investigational Site Number 840023
    • New York
      • New York, New York, United States, 10021
        • Sanofi-Aventis Investigational Site Number 840005
      • New York, New York, United States, 10029-6574
        • Sanofi-Aventis Investigational Site Number 840006
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Sanofi-Aventis Investigational Site Number 840003
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Sanofi-Aventis Investigational Site Number 840018
      • Columbus, Ohio, United States, 43210
        • Sanofi-Aventis Investigational Site Number 840002
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Sanofi-Aventis Investigational Site Number 840020

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Alvocidib
Cycles with 4-week treatment with alvocidib followed by 2-week rest period for up to a maximum of 6 cycles
Drug: 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 Names:
  • HMR1275

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to a maximum of 6 cycles

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to a maximum of 6 cycles
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.
Up to a maximum of 6 cycles
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.
Up to a maximum of 6 cycles
Overview of adverse events
Time Frame: from study drug administration up to 30 days after last study drug administration
from study drug administration up to 30 days after last study drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

April 20, 2007

First Submitted That Met QC Criteria

April 20, 2007

First Posted (ESTIMATE)

April 23, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

February 12, 2013

Last Update Submitted That Met QC Criteria

February 8, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC6663
  • 2006-006152-34 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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