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.
Sponsor:
Astex Pharmaceuticals
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
Astex Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00042003
First received: July 19, 2002
Last updated: January 22, 2013
Last verified: June 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Myelogenous Leukemia |
Drug: decitabine (5-aza-2'deoxycytidine) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II, Multicenter Study of Decitabine (5-aza-2'Deoxycytidine) in Chronic Myelogenous Leukemia Blast Phase Refractory to Imatinib Mesylate (STI 571) |
Resource links provided by NLM:
Further study details as provided by Astex Pharmaceuticals:
Eligibility| Ages Eligible for Study: | 2 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 </= 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00042003
Locations
| United States, California | |
| City of Hope Medical Center | |
| Duarte, California, United States | |
| Scripps Clinic | |
| Escondido, California, United States | |
| USC/Norris Cancer Center | |
| Los Angeles, California, United States | |
| United States, Minnesota | |
| Metro-Minnesota CCOP | |
| St. Louis Park, Minnesota, United States | |
| United States, New York | |
| New York Medical College | |
| Valhalla, New York, United States | |
| United States, South Carolina | |
| Liberty Hematology/Oncology | |
| Columbia, South Carolina, United States | |
| United States, Texas | |
| University of Texas MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Canada, Ontario | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada | |
Sponsors and Collaborators
Astex Pharmaceuticals
Eisai Inc.
More Information
No publications provided
| Responsible Party: | Astex Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00042003 History of Changes |
| Other Study ID Numbers: | DAC-012, DACO-012 |
| Study First Received: | July 19, 2002 |
| Last Updated: | January 22, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Astex Pharmaceuticals:
|
Chronic myelogenous leukemia CML CML-BP Blast phase Decitabine 5-aza-2'deoxycytidine |
Methylation STI 571 Imatinib mesylate Gleevec BCR/ABL |
Additional relevant MeSH terms:
|
Blast Crisis Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neoplasms by Histologic Type Neoplasms Cell Transformation, Neoplastic Neoplastic Processes Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Pathologic Processes |
Azacitidine Decitabine Imatinib Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors |
ClinicalTrials.gov processed this record on June 13, 2013