Lenalidomide (Revlimid) in Chronic Lymphocytic Leukemia (CLL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00267059
Recruitment Status : Completed
First Posted : December 20, 2005
Results First Posted : April 21, 2011
Last Update Posted : August 7, 2012
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Chronic Lymphocytic Leukemia
Intervention: Drug: Lenalidomide

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

Participant Flow:   Overall Study

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

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   25 
>=65 years   19 
[Units: Years]
Median (Full Range)
 (49 to 86) 
[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

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

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

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00267059     History of Changes
Other Study ID Numbers: 2005-0175
First Submitted: December 19, 2005
First Posted: December 20, 2005
Results First Submitted: September 24, 2009
Results First Posted: April 21, 2011
Last Update Posted: August 7, 2012