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

Chronic Myelogenous Leukemia Clinical Trial

Official title:

A Phase II, Multicenter Study of Decitabine (5-Aza-2'Deoxycytidine) in Chronic Myelogenous Leukemia Accelerated Phase Refractory to Imatinib Mesylate (STI 571)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00041990
• Other study ID #: DAC-013
• Secondary ID: DACO-013
• Status: Completed
• Phase: Phase 2
• First received: July 19, 2002
• Last updated: December 12, 2007
• Start date: July 2002

Study information

• Verified date: December 2007
• Source: Astex Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Myelogenous Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Drug:
• decitabine (5-aza-2'deoxycytidine)

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto	Ontario
United States	Liberty Hematology/Oncology	Columbia	South Carolina
United States	City of Hope Medical Center	Duarte	California
United States	Scripps Clinic	Escondido	California
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	USC/Norris Cancer Center	Los Angeles	California
United States	Metro-Minnesota CCOP	St. Louis Park	Minnesota
United States	New York Medical College	Valhalla	New York

Sponsors (2)

Lead Sponsor	Collaborator
Astex Pharmaceuticals	Eisai Inc.

Countries where clinical trial is conducted

United States,  Canada,