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

This study has been completed.

Sponsor:

Collaborator:

Eisai Inc.

Information provided by:

Astex Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00041990

First received: July 19, 2002

Last updated: December 12, 2007

Last verified: December 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

July 19, 2002

Last Updated Date

December 12, 2007

Start Date ^ICMJE

July 2002

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00041990 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Chronic Myelogenous Leukemia

Intervention ^ICMJE

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

Study Arms

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

2 Years and older (Child, Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Canada, United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00041990

Other Study ID Numbers ^ICMJE

DAC-013
DACO-013

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Astex Pharmaceuticals

Collaborators ^ICMJE

Eisai Inc.

Investigators ^ICMJE

Not Provided

PRS Account

Astex Pharmaceuticals

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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