Overview

Phase II Trial of Decitabine in Patients With Chronic Myelogenous Leukemia Chronic 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 chronic 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.
Treatments:
Azacitidine
Decitabine
Imatinib Mesylate
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
- 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