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

History of Changes

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
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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.
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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 ]

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Serious Adverse Events

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Other Adverse Events

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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
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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

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

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