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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00041990
Recruitment Status : Completed
First Posted : July 23, 2002
Last Update Posted : December 17, 2007
Eisai Inc.
Information provided by:
Astex Pharmaceuticals

July 19, 2002
July 23, 2002
December 17, 2007
July 2002
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Complete list of historical versions of study NCT00041990 on 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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Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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 Identifier (NCT Number) in Medline.
Same as current
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  • 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


  • 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
Sexes Eligible for Study: All
2 Years and older   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
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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