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Lenalidomide (Revlimid) in Chronic Lymphocytic Leukemia (CLL)

This study has been completed.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00267059
First received: December 19, 2005
Last updated: August 1, 2012
Last verified: August 2012
Results First Received: September 24, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Chronic Lymphocytic Leukemia
Leukemia
Intervention: Drug: Lenalidomide

  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 12/7/05 - 8/7/09; all patients were registered at The University of Texas M.D. Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Forty five patients were registered on this study. Forty four were evaluable. One patient never received treatment.

Reporting Groups
  Description
Lenalidomide 10 mg/day, orally once a day for 28 days

Participant Flow:   Overall Study
    Lenalidomide  
STARTED     44  
COMPLETED     44  
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
Lenalidomide 10 mg/day, orally once a day for 28 days

Baseline Measures
    Lenalidomide  
Number of Participants  
[units: participants]
  44  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     25  
>=65 years     19  
Age  
[units: years]
Median ( Full Range )
  63  
  ( 49 to 86 )  
Gender  
[units: participants]
 
Female     14  
Male     30  
Region of Enrollment  
[units: participants]
 
United States     44  



  Outcome Measures

1.  Primary:   Number of Patients in Overall Response Categories   [ Time Frame: Evaluated after three 28-day cycles of lenalidomide. ]


  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
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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: Alessandra Ferrajoli, MD, BS / Associate Professor
Organization: The University of Texas M. D. Anderson Cancer Center
phone: 713-792-2063
e-mail: eharriso@mdanderson.org


No publications provided by M.D. Anderson Cancer Center

Publications automatically indexed to this study:

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00267059     History of Changes
Other Study ID Numbers: 2005-0175
Study First Received: December 19, 2005
Results First Received: September 24, 2009
Last Updated: August 1, 2012
Health Authority: United States: Food and Drug Administration