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

Primary Purpose

Chronic Myelogenous Leukemia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
decitabine (5-aza-2'deoxycytidine)
Sponsored by
Astex Pharmaceuticals, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Myelogenous Leukemia focused on measuring Chronic myelogenous leukemia, CML, CML-CP, Chronic phase, Decitabine, 5-aza-2'deoxycytidine, Methylation, STI 571, Imatinib mesylate, Gleevec, BCR/ABL

Eligibility Criteria

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

Inclusion: Histologically confirmed diagnosis of CML chronic 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 chronic 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

Sites / Locations

  • City of Hope Medical Center
  • Scripps Clinic
  • USC/Norris Cancer Center
  • Metro-Minnesota CCOP
  • New York Medical College
  • Liberty Hematology/Oncology
  • University of Texas MD Anderson Cancer Center
  • Princess Margaret Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 19, 2002
Last Updated
October 12, 2009
Sponsor
Astex Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00042016
Brief Title
Phase II Trial of Decitabine in Patients With Chronic Myelogenous Leukemia Chronic Phase Who Are Refractory to Imatinib Mesylate (Gleevec)
Official Title
A Phase II, Multicenter Study of Decitabine (5-aza-2'Deoxycytidine) in Chronic Myelogenous Leukemia Chronic Phase Refractory to Imatinib Mesylate (STI 571)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2005
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Astex Pharmaceuticals, Inc.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myelogenous Leukemia
Keywords
Chronic myelogenous leukemia, CML, CML-CP, Chronic phase, Decitabine, 5-aza-2'deoxycytidine, Methylation, STI 571, Imatinib mesylate, Gleevec, BCR/ABL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
decitabine (5-aza-2'deoxycytidine)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion: Histologically confirmed diagnosis of CML chronic 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 chronic 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
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
Country
United States
Facility Name
Scripps Clinic
City
Escondido
State/Province
California
Country
United States
Facility Name
USC/Norris Cancer Center
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Metro-Minnesota CCOP
City
St. Louis Park
State/Province
Minnesota
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
Country
United States
Facility Name
Liberty Hematology/Oncology
City
Columbia
State/Province
South Carolina
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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