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

This study has been completed.
Sponsor:
Collaborator:
Eisai Inc.
Information provided by:
Astex Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00041990
First received: July 19, 2002
Last updated: December 12, 2007
Last verified: December 2007

July 19, 2002
December 12, 2007
July 2002
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Complete list of historical versions of study NCT00041990 on ClinicalTrials.gov Archive Site
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Phase II Trial of Decitabine in Patients With Chronic Myelogenous Leukemia Accelerated Phase Who Are Refractory to Imatinib Mesylate (Gleevec)
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.

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Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Myelogenous Leukemia
Drug: decitabine (5-aza-2'deoxycytidine)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
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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
Both
2 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00041990
DAC-013, DACO-013
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Astex Pharmaceuticals
Eisai Inc.
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Astex Pharmaceuticals
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP