Phase II Trial of Decitabine in Patients With Chronic Myelogenous Leukemia Accelerated Phase Who Are Refractory to Imatinib Mesylate (Gleevec)

December 12, 2007 updated by: Astex Pharmaceuticals, Inc.

A Phase II, Multicenter Study of Decitabine (5-Aza-2'Deoxycytidine) in Chronic Myelogenous Leukemia Accelerated Phase Refractory to Imatinib Mesylate (STI 571)

To determine the safety and efficacy of decitabine in patients with Philadelphia chromosome-positive chronic myelogenous leukemia accelerated phase that were previously treated with imatinib mesylate (STI 571) and became resistant/refractory or were found to be intolerant to the drug.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

40

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Princess Margaret Hospital
  • United States
    • California
      • Duarte, California, United States
        • City of Hope Medical Center
      • Escondido, California, United States
        • Scripps Clinic
      • Los Angeles, California, United States
        • USC/Norris Cancer Center
    • Minnesota
      • St. Louis Park, Minnesota, United States
        • Metro-Minnesota CCOP
    • New York
      • Valhalla, New York, United States
        • New York Medical College
    • South Carolina
      • Columbia, South Carolina, United States
        • Liberty Hematology/Oncology
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

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

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion:

  • Histologically confirmed diagnosis of CML accelerated phase
  • Ph chromosome-positive

  • Previous treatment with imatinib mesylate resulting in:

    i) Hematologic Resistance / Hematologic Refractory: Based on a physician's (documented) decision to discontinue imatinib mesylate treatment due to failure of continued benefit or no benefit to the patient, ii) Imatinib Mesylate Intolerance: any toxicity resulting in a physician's (documented) decision to discontinue imatinib mesylate treatment.

  • Patients must have recovered from the side effects of previous CML therapy for accelerated phase with the exception of hydroxyurea
  • Age >/= 2 years
  • Bilirubin </= 3 x the upper limit of normal (ULN), SGOT and SGPT </= 3 x ULN, except </= 5 x ULN in leukemic involvement of the liver, serum creatinine </= 2 x ULN
  • WHO performance status 0-3
  • A negative serum hCG pregnancy test in patients of childbearing potential
  • Able to give signed informed consent directly or through a parent or guardian for minors

Exclusion:

  • Leukemic involvement of the central nervous system
  • Active malignancy other than CML or non-melanoma cancer of the skin
  • Previous treatment for CML with another investigational agent within 28 days of study entry
  • At study entry, patients who were treated with: imatinib mesylate within the past 48 hours; interferon-alpha within the past 48 hours; homoharringtonine within the past 14 days; low-dose cytosine arabinoside within 7 days, moderate dose within 14 days, or high dose within 28 days; etoposide, anthracyclines, or mitoxantrone within 21 days; busulfan within the past six weeks
  • Patients who had received hematopoietic stem cell transplantation within 6 weeks of Day 1 decitabine therapy
  • Patients with Grade 3/4 cardiac disease or any other serious concurrent medical condition.
  • Patients who are pregnant or nursing. All patients of childbearing potential must practice effective methods of contraception while on study.
  • Patients with mental illness or other condition precluding their ability to give informed consent or to comply with study requirements
  • Patients with systemic, uncontrolled infections

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

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

Sponsor

Astex Pharmaceuticals, Inc.

Collaborators

Eisai Inc.

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

July 1, 2002

Study Registration Dates

First Submitted

July 19, 2002

First Submitted That Met QC Criteria

July 22, 2002

First Posted (Estimate)

July 23, 2002

Study Record Updates

Last Update Posted (Estimate)

December 17, 2007

Last Update Submitted That Met QC Criteria

December 12, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAC-013
  • DACO-013

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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