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Therapy of Chronic Lymphocytic Leukemia With Dasatinib (BMS-354825)

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00364286
First received: August 14, 2006
Last updated: June 12, 2013
Last verified: June 2013
Results First Received: June 12, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Leukemia
Lymphoma
Intervention: Drug: Dasatinib (BMS-354825)

  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
Recruitment Period: 8/14/2006 through 11/28/2012. All participants recruited at The University of Texas (UT) MD Anderson Cancer Center.

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 Dasatinib 50mg Orally twice daily.

Participant Flow:   Overall Study
    Dasatinib  
STARTED     17  
COMPLETED     17  
NOT COMPLETED     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 Dasatinib 50mg Orally twice daily.

Baseline Measures
    Dasatinib  
Number of Participants  
[units: participants]
  17  
Age  
[units: years]
Median ( Full Range )
  67  
  ( 42 to 83 )  
Gender  
[units: participants]
 
Female     4  
Male     13  
Region of Enrollment  
[units: participants]
 
United States     17  



  Outcome Measures

1.  Primary:   Participants With Objective Response   [ Time Frame: 4 week treatment cycle ]


  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
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Susan O'Brien, MD/ Professor
Organization: The University of Texas MD Anderson Cancer Center
phone: 713-792-7543
e-mail: eharriso@mdanderson.org


No publications provided


Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00364286     History of Changes
Other Study ID Numbers: 2005-0497
Study First Received: August 14, 2006
Results First Received: June 12, 2013
Last Updated: June 12, 2013
Health Authority: United States: Food and Drug Administration