Phase II Trial of Decitabine in Patients With Chronic Myelogenous Leukemia Blast Phase Who Are Refractory to Imatinib Mesylate (Gleevec)
This study has been completed.
First Posted: July 23, 2002
Last Update Posted: January 23, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Information provided by (Responsible Party):
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.
Chronic Myelogenous Leukemia
Drug: decitabine (5-aza-2'deoxycytidine)
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
||A Phase II, Multicenter Study of Decitabine (5-aza-2'Deoxycytidine) in Chronic Myelogenous Leukemia Blast Phase Refractory to Imatinib Mesylate (STI 571)
| Estimated Enrollment:
| Study Start Date:
| Primary Completion Date:
||December 2004 (Final data collection date for primary outcome measure)
Information from the National Library of Medicine
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|Ages Eligible for Study:
||2 Years and older (Child, Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- 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 </= 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
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00042003
|City of Hope Medical Center
|Duarte, California, United States |
|Escondido, California, United States |
|USC/Norris Cancer Center
|Los Angeles, California, United States |
|St. Louis Park, Minnesota, United States |
|New York Medical College
|Valhalla, New York, United States |
|Columbia, South Carolina, United States |
|University of Texas MD Anderson Cancer Center
|Houston, Texas, United States, 77030 |
|Princess Margaret Hospital
|Toronto, Ontario, Canada |
History of Changes
|Other Study ID Numbers:
||July 19, 2002
||July 23, 2002
|Last Update Posted:
||January 23, 2013
Keywords provided by Astex Pharmaceuticals:
Chronic myelogenous leukemia
Additional relevant MeSH terms:
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Bone Marrow Diseases
Cell Transformation, Neoplastic
Protein Kinase Inhibitors
Molecular Mechanisms of Pharmacological Action