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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:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00362466
First received: August 9, 2006
Last updated: November 18, 2009
Last verified: November 2009

August 9, 2006
November 18, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • CCyR Rates [ Time Frame: Month 3, Month 12, Month 24 and Month 36 ] [ Designated as safety issue: No ]
  • Estimate Time to MMR and CCyR [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • Progression Free Survival (PFS) [ Time Frame: at 36 months ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: Yes ]
  • Duration of CCyR and MMR [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • Best MMR Rates [ Time Frame: throughout study ] [ Designated as safety issue: No ]
  • 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00362466
CA180-044
No
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