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

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ClinicalTrials.gov Identifier: NCT00042016
Recruitment Status : Completed
First Posted : July 23, 2002
Last Update Posted : October 14, 2009
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Chronic Myelogenous Leukemia Drug: decitabine (5-aza-2'deoxycytidine) Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2002


Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00042016


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

ClinicalTrials.gov Identifier: NCT00042016     History of Changes
Other Study ID Numbers: DAC-014
DACO-014
First Posted: July 23, 2002    Key Record Dates
Last Update Posted: October 14, 2009
Last Verified: June 2005

Keywords provided by Astex Pharmaceuticals:
Chronic myelogenous leukemia
CML
CML-CP
Chronic phase
Decitabine
5-aza-2'deoxycytidine
Methylation
STI 571
Imatinib mesylate
Gleevec
BCR/ABL

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Decitabine
Imatinib Mesylate
Azacitidine
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites