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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) Eastern Cooperative Oncology Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00070499 |
RATIONALE: Imatinib mesylate or dasatinib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: This randomized phase II trial is studying imatinib mesylate at two different doses and dasatinib to see how well they work in treating patients with previously untreated chronic phase chronic myelogenous leukemia.
Condition | Intervention | Phase |
---|---|---|
Leukemia |
Drug: dasatinib Drug: imatinib mesylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Phase IIb Study Of Molecular Responses To Imatinib At Standard Or Increased Doses or Dasatinib (NSC-732517) For Previously Untreated Patients With Chronic Myelogenous Leukemia (CML) In Chronic Phase |
Estimated Enrollment: | 400 |
Study Start Date: | August 2004 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm I: Active Comparator
Patients receive oral imatinib mesylate once daily.
|
Drug: imatinib mesylate
Given orally
|
Arm II: Experimental
Patients receive oral imatinib mesylate twice daily.
|
Drug: imatinib mesylate
Given orally
|
Arm III: Experimental
Patients receive oral dasatinib twice daily.
|
Drug: dasatinib
Given orally
|
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Hasford risk category (low vs intermediate vs high). Patients are randomized to 1 of 3 treatment arms.
Patients are followed for up to 5 years.
PROJECTED ACCRUAL: A total of 335 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of chronic phase chronic myelogenous leukemia (CML) by bone marrow aspiration, biopsy, and peripheral blood counts, meeting criteria for
1 of the following:
Philadelphia chromosome-positive* or presence of the variants of the (9;22) translocation by cytogenetics or fluorescent in situ hybridization
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
No significant bleeding disorder unrelated to cancer including:
Hepatic
Renal
Cardiovascular
No cardiac symptoms including any of the following:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No prior chemotherapy for peripheral blood stem cell mobilization
No other concurrent anticancer chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent therapeutic anticoagulation with warfarin
No concurrent drugs* that have a risk of causing Torsades de Pointe including (arm III patients only):
No concurrent drugs that irreversibly inhibit platelet function, including any of the following (arm III only):
Aspirin
Investigator: | Brian J. Druker, MD | Oregon Health and Science University |
Investigator: | Marilyn L. Slovak, PhD | Beckman Research Institute |
Investigator: | Peter D. Emanuel, MD | Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham |
Responsible Party: | Southwest Oncology Group - Group Chair's Office ( Laurence H. Baker ) |
Study ID Numbers: | CDR0000334588, SWOG-S0325, ECOG-S0325 |
Study First Received: | October 3, 2003 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00070499 History of Changes |
Health Authority: | United States: Federal Government |
chronic phase chronic myelogenous leukemia Philadelphia chromosome positive chronic myelogenous leukemia |
Imatinib Philadelphia Chromosome Leukemia Hematologic Diseases Dasatinib Myeloproliferative Disorders |
Leukemia, Myelogenous, Chronic, BCR-ABL Positive Chronic Myelogenous Leukemia Leukemia, Myeloid, Chronic-Phase Leukemia, Myeloid Bone Marrow Diseases Protein Kinase Inhibitors |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hematologic Diseases Myeloproliferative Disorders Enzyme Inhibitors Leukemia, Myeloid Leukemia, Myeloid, Chronic-Phase Protein Kinase Inhibitors |
Pharmacologic Actions Imatinib Leukemia Neoplasms Therapeutic Uses Dasatinib Leukemia, Myelogenous, Chronic, BCR-ABL Positive Bone Marrow Diseases |