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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

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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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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Sponsors and Collaborators
Bristol-Myers Squibb
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

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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:
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Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
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