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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astex Pharmaceuticals; Astex Pharmaceuticals, Inc.
• Collaborator: Eisai Inc.
• Treatments: Azacitidine; Decitabine; Imatinib Mesylate

Criteria

Inclusion:

• Histologically confirmed diagnosis of CML blast 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 blast phase with the exception of hydroxyurea

• Age >/= 2 years

• Bilirubin
• 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