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
Results First Received: July 24, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Leukemia
Interventions: Drug: Dasatinib
Drug: Imatinib

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 156 subjects were to be enrolled; however, the attempts were unsuccessful and the study was closed after 3 subjects were enrolled. A fourth subject underwent screening, but was not randomized since the subject did not meet the inclusion criteria.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Dasatinib 100 mg once daily (QD)
Imatinib 600 mg QD

Participant Flow:   Overall Study
    Dasatinib     Imatinib  
STARTED     2     1  
COMPLETED     2     1  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Dasatinib 100 mg QD
Imatinib 600 mg QD
Total Total of all reporting groups

Baseline Measures
    Dasatinib     Imatinib     Total  
Number of Participants  
[units: participants]
  2     1     3  
Age  
[units: Participants]
     
30- to 39-years-old     1     0     1  
40- to 49-years-old     1     0     1  
50- to 59-years-old     0     1     1  
Gender  
[units: participants]
     
Female     0     1     1  
Male     2     0     2  
Race/Ethnicity, Customized  
[units: participants]
     
White     2     1     3  



  Outcome Measures
  Show All Outcome Measures

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

2.  Secondary:   Major Molecular Response (MMR) Rates   [ Time Frame: Month 3, Month 6, Month 12, Month 24 and Month 36 ]

3.  Secondary:   CCyR Rates   [ Time Frame: Month 3, Month 12, Month 24 and Month 36 ]

4.  Secondary:   Estimate Time to MMR and CCyR   [ Time Frame: throughout the study ]

5.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: at 36 months ]

6.  Secondary:   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. ]

7.  Secondary:   Duration of CCyR and MMR   [ Time Frame: Throughout the study ]

8.  Secondary:   Best MMR Rates   [ Time Frame: throughout study ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study was terminated early due to insufficient enrollment.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


No publications provided


Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00362466     History of Changes
Other Study ID Numbers: CA180-044
Study First Received: August 9, 2006
Results First Received: July 24, 2009
Last Updated: November 18, 2009
Health Authority: United States: Food and Drug Administration