A Study of Dasatinib vs. High-Dose Imatinib (600 mg) in Patients With Chronic Phase Chronic Myeloid Leukemia (CML) Who Failed to Achieve Complete Cytogenetic Response After 3-18 Months of Imatinib Therapy
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| ClinicalTrials.gov Identifier: NCT00362466 |
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Recruitment Status
:
Terminated
(Insufficient Enrollment)
First Posted
: August 10, 2006
Results First Posted
: September 3, 2009
Last Update Posted
: November 20, 2009
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Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
- Study Details
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Brief Summary:
The purpose of this clinical research study is to compare the rate of complete cytogenetic response of dasatinib to imatinib therapy at 6 months after randomization in chronic phase CML patients. The safety of this treatment will also be studied.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Leukemia | Drug: Dasatinib Drug: Imatinib | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 3 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open-Label Randomized Phase III Study of Dasatinib vs. High-Dose (600 mg) Imatinib Mesylate in the Treatment of Subjects With Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Are Imatinib Failures or Who Have Had a Suboptimal Response After 3-18 Months of Therapy With 400 mg Imatinib |
| Study Start Date : | April 2007 |
| Actual Primary Completion Date : | June 2008 |
| Actual Study Completion Date : | June 2008 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Chronic myeloid leukemia
Genetic and Rare Diseases Information Center resources:
Myeloid Leukemia
Chronic Myeloid Leukemia
Chronic Myeloproliferative Disorders
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: A
50-180 mg once daily (QD)
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Drug: Dasatinib
Tablets, Oral, Once daily, 5-7 years
Other Name: Sprycel®
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Active Comparator: B
200-800 mg QD
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Drug: Imatinib
Tablets, Oral, Once daily, 5-7 years
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Primary Outcome Measures
:
- Complete Cytogenetic Response (CCyR) Rate at Month 6 [ Time Frame: Month 6 ]
Secondary Outcome Measures
:
- Major Molecular Response (MMR) Rates [ Time Frame: Month 3, Month 6, Month 12, Month 24 and Month 36 ]
- CCyR Rates [ Time Frame: Month 3, Month 12, Month 24 and Month 36 ]
- Estimate Time to MMR and CCyR [ Time Frame: throughout the study ]
- Progression Free Survival (PFS) [ Time Frame: at 36 months ]
- Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs [ Time Frame: From 2 weeks prior to randomization through Month 36. At least every 4 weeks until all study-related toxicities resolve to baseline, stabilize, or are deemed irreversible. ]
- Duration of CCyR and MMR [ Time Frame: Throughout the study ]
- Best MMR Rates [ Time Frame: throughout study ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Men and women ≥18 years diagnosed with Chronic Phase Philadelphia chromosome positive (CP Ph+) CML who have failed to achieve CCyR after 3-18 months of therapy with imatinib 400 mg
- Treatment initiation with imatinib 400 mg within 6 months of initial CML diagnosis
- Able to tolerate chronic administration of imatinib at the highest dose (400-600 mg) the subject has received in the past
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2
- Adequate hepatic and renal function
Exclusion Criteria:
- Eligible and willing to undergo immediate autologous/allogeneic stem cell transplant
- Previous diagnosis of accelerated/blast crisis CML
- Subjects with clonal evolution in Ph+ cells observed in ≥2 metaphases
- Previous documentation of T315I mutation
- Uncontrolled or significant cardiovascular disease
- Serious uncontrolled medical disorder/active infection
- History of significant bleeding disorder unrelated to CML
- Intolerance to imatinib ≥400 mg
- Concurrent malignancies other than CML
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): NCT00362466
Hide Study Locations
Locations
| United States, Alabama | |
| Dr. Marshall Schreeder | |
| Huntsville, Alabama, United States, 35805 | |
| United States, Arkansas | |
| Local Institution | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Local Institution | |
| Alhambra, California, United States, 91801 | |
| Local Institution | |
| Anaheim, California, United States, 92801 | |
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| Beverly Hills, California, United States, 90211 | |
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| Fullerton, California, United States, 92835 | |
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| La Jolla, California, United States, 92093 | |
| Local Institution | |
| La Verne, California, United States, 91750 | |
| Local Institution | |
| Long Beach, California, United States, 90813 | |
| Local Institution | |
| Los Angeles, California, United States, 90033 | |
| Local Institution | |
| Los Angeles, California, United States, 90048 | |
| Local Institution | |
| Los Angeles, California, United States, 90095 | |
| Local Institution | |
| Northridge, California, United States, 91325 | |
| Local Institution | |
| Oxnard, California, United States, 93030 | |
| Local Institution | |
| Redondo Beach, California, United States, 90277 | |
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| San Francisco, California, United States, 94143 | |
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| Santa Maria, California, United States, 93454 | |
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| Stanford, California, United States, 94305 | |
| United States, Colorado | |
| Local Institution | |
| Aurora, Colorado, United States, 80045 | |
| United States, Florida | |
| Local Institution | |
| Jacksonville, Florida, United States, 32207 | |
| Local Institution | |
| Jacksonville, Florida, United States, 32209 | |
| M.D. Anderson Cancer Center Orlando | |
| Orlando, Florida, United States, 32806 | |
| Local Institution | |
| Pembroke Pines, Florida, United States, 33028 | |
| United States, Illinois | |
| Local Institution | |
| Chicago, Illinois, United States, 60637 | |
| United States, Indiana | |
| Local Institution | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Kansas | |
| Local Institution | |
| Kansas City, Kansas, United States, 66160 | |
| United States, Kentucky | |
| Local Institution | |
| Hazard, Kentucky, United States, 41701 | |
| United States, Michigan | |
| Local Institution | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Minnesota | |
| Local Institution | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Missouri | |
| Local Institution | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| Local Institution | |
| Omaha, Nebraska, United States, 68114 | |
| United States, Nevada | |
| Local Institution | |
| Las Vegas, Nevada, United States, 89135 | |
| United States, New Jersey | |
| Local Institution | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| Local Institution | |
| Buffalo, New York, United States, 14263 | |
| New York Presbyterian Hospital | |
| New York, New York, United States, 10021 | |
| New York Medical College | |
| Valhalla, New York, United States, 10595 | |
| United States, North Carolina | |
| Local Institution | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Local Institution | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Oklahoma | |
| Local Institution | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| Local Institution | |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, Pennsylvania | |
| Local Institution | |
| Baltimore, Pennsylvania, United States, 21229 | |
| Local Institution | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| United States, South Carolina | |
| Santee Hematology/Oncology | |
| Sumter, South Carolina, United States, 29150 | |
| United States, Texas | |
| Local Institution | |
| Dallas, Texas, United States, 75390 | |
| Local Institution | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| Responsible Party: | Study Director, Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00362466 History of Changes |
| Other Study ID Numbers: |
CA180-044 |
| First Posted: | August 10, 2006 Key Record Dates |
| Results First Posted: | September 3, 2009 |
| Last Update Posted: | November 20, 2009 |
| Last Verified: | November 2009 |
Keywords provided by Bristol-Myers Squibb:
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Leukemia (chronic myeloid leukemia - chronic phase) |
Additional relevant MeSH terms:
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Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid, Chronic-Phase Neoplasms by Histologic Type Neoplasms Myeloproliferative Disorders Bone Marrow Diseases |
Hematologic Diseases Imatinib Mesylate Dasatinib Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |