Lenalidomide as Initial Treatment of Patients With Chronic Lymphocytic Leukemia (CLL) Age 65 and Older
|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.|
|ClinicalTrials.gov Identifier: NCT00535873|
Recruitment Status : Completed
First Posted : September 26, 2007
Results First Posted : September 2, 2013
Last Update Posted : September 2, 2013
- To assess the activity of lenalidomide in patients with previously untreated chronic lymphocytic leukemia (CLL) age 65 and older.
- To assess the tolerability of lenalidomide in patients with untreated CLL age 65 and older
|Condition or disease||Intervention/treatment||Phase|
|Leukemia CLL Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma||Drug: Lenalidomide||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Lenalidomide as Initial Treatment of Patients With Chronic Lymphocytic Leukemia Age 65 or Older.|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
Lenalidomide starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
Starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
- Overall Response Rate (ORR) [ Time Frame: From 3 cycles (90 days) up to 6 cycles (approximately 180 days) ]ORR defined as number of participants with best response of Complete or Partial response out of total number of participants. Response assessed using the NCI Working Group criteria for response following 3 cycles, 6 cycles and yearly thereafter.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00535873
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Alessandra Ferrajoli, M.D.||M.D. Anderson Cancer Center|