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

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ClinicalTrials.gov Identifier: NCT00364286
Recruitment Status : Completed
First Posted : August 15, 2006
Results First Posted : August 21, 2013
Last Update Posted : May 22, 2018
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Leukemia
Lymphoma
Intervention: Drug: Dasatinib (BMS-354825)

  Participant Flow

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
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Reporting Groups
  Description
Dasatinib Dasatinib 50mg Orally twice daily.

Participant Flow:   Overall Study
    Dasatinib
STARTED   17 
COMPLETED   14 
NOT COMPLETED   3 
Withdrawal by Subject                1 
Adverse Event                2 



  Baseline Characteristics

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 
Overall Participants Analyzed 
[Units: Participants]
 		 17 
Age 
[Units: Years]
Median (Full Range) 		 67 
 (42 to 83) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		 
Female      4  23.5% 
Male      13  76.5% 
Region of Enrollment 
[Units: Participants]
 		 
United States   17 


  Outcome Measures

1.  Primary:   Participants With Objective Response   [ Time Frame: up to 3 months ]
  Show Outcome Measure 1


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
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  More Information

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



Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00364286     History of Changes
Other Study ID Numbers: 2005-0497
First Submitted: August 14, 2006
First Posted: August 15, 2006
Results First Submitted: June 12, 2013
Results First Posted: August 21, 2013
Last Update Posted: May 22, 2018