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

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. Read our disclaimer for details. Identifier: NCT00362466
Recruitment Status : Terminated (Insufficient Enrollment)
First Posted : August 10, 2006
Results First Posted : September 3, 2009
Last Update Posted : November 20, 2009
Information provided by:
Bristol-Myers Squibb

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

Arm Intervention/treatment
Active Comparator: A
50-180 mg once daily (QD)
Drug: Dasatinib
Tablets, Oral, Once daily, 5-7 years
Other Name: Sprycel®
Active Comparator: B
200-800 mg QD
Drug: Imatinib
Tablets, Oral, Once daily, 5-7 years

Primary Outcome Measures :
  1. Complete Cytogenetic Response (CCyR) Rate at Month 6 [ Time Frame: Month 6 ]

Secondary Outcome Measures :
  1. Major Molecular Response (MMR) Rates [ Time Frame: Month 3, Month 6, Month 12, Month 24 and Month 36 ]
  2. CCyR Rates [ Time Frame: Month 3, Month 12, Month 24 and Month 36 ]
  3. Estimate Time to MMR and CCyR [ Time Frame: throughout the study ]
  4. Progression Free Survival (PFS) [ Time Frame: at 36 months ]
  5. 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. ]
  6. Duration of CCyR and MMR [ Time Frame: Throughout the study ]
  7. 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

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 identifier (NCT number): NCT00362466

  Hide Study 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
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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
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La Verne, California, United States, 91750
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Long Beach, California, United States, 90813
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Los Angeles, California, United States, 90033
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Los Angeles, California, United States, 90048
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Los Angeles, California, United States, 90095
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Northridge, California, United States, 91325
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Oxnard, California, United States, 93030
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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
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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
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb 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:
Leukemia (chronic myeloid leukemia - chronic phase)

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action