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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

This study has been terminated.
(Insufficient Enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00362466
First Posted: August 10, 2006
Last Update Posted: November 20, 2009
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.
Information provided by:
Bristol-Myers Squibb
August 9, 2006
August 10, 2006
July 24, 2009
September 3, 2009
November 20, 2009
April 2007
June 2008   (Final data collection date for primary outcome measure)
Complete Cytogenetic Response (CCyR) Rate at Month 6 [ Time Frame: Month 6 ]
Complete Cytogenetic Response rate at 6 months
Complete list of historical versions of study NCT00362466 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Major Molecular response rates 3, 6, 12, 24 and 36 months
  • Complete Cytogenetic Response rates at 3, 12, 24 and 36 months
  • Estimate time to and duration of MMR and CCyR
  • Progression Free Survival at 36 months
  • Assess the long term safety of dasatinib
Not Provided
Not Provided
 
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
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Leukemia
  • Drug: Dasatinib
    Tablets, Oral, Once daily, 5-7 years
    Other Name: Sprycel®
  • Drug: Imatinib
    Tablets, Oral, Once daily, 5-7 years
  • Active Comparator: A
    50-180 mg once daily (QD)
    Intervention: Drug: Dasatinib
  • Active Comparator: B
    200-800 mg QD
    Intervention: Drug: Imatinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
June 2008
June 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
Canada
 
NCT00362466
CA180-044
No
Not Provided
Not Provided
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP