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Phase II trial of decitabine in patients with chronic myelogenous leukemia chronic phase who are refractory to imatinib mesylate (Gleevec)



Phase II trial of decitabine in patients with chronic myelogenous leukemia chronic phase who are refractory to imatinib mesylate (Gleevec)

For Condition: Chronic Myelogenous Leukemia
Status: Recruiting
Sponsor(s): SuperGen ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 2 Years/
Genders: Both
Protocol Entry 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 Total Enrollment: 40

Location and Contact Information:

University of Texas MD Anderson Cancer Center *Recruiting*
Houston,  Texas,  77030
United States
Recruiting Jean-Pierre  Issa


Additional Information:
Study ID Numbers:
  SGI-DAC-014;  DAC-014
Study Start Date: July 2002
Record last reviewed: July 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00042016

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