Lenalidomide and Ofatumumab in Previously Treated Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (CLL/SLL)
|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: NCT01002755|
Recruitment Status : Completed
First Posted : October 27, 2009
Last Update Posted : February 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma||Drug: Lenalidomide Drug: Ofatumumab||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Combination of Lenalidomide and Ofatumumab in Patients With Previously Treated Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (CLL/SLL)|
|Actual Study Start Date :||January 19, 2010|
|Actual Primary Completion Date :||January 31, 2018|
|Actual Study Completion Date :||January 31, 2018|
Experimental: Lenalidomide + Ofatumumab
Lenalidomide 10 mg daily up to 24 cycles (cycle = 28 day); Ofatumumab IV infusions 300 mg week 1; 1,000 mg week 2, 3 and 4, then monthly during months 2-6 and once every two months during months 7-24.
10 mg daily, started on day 9 (day after second infusion of ofatumumab) and continued daily through 24 cycles (cycle = 28 day)
4 weekly IV infusions of 300 mg week 1, 1,000 mg week 2, 3 and 4, then monthly during months 2-6 and once every two months during months 7-24 (even months: 8,10,12 etc.).
- Overall Response [ Time Frame: Responses assessed after 3, 6, 12, 18 and 24 cycles (each cycle is 28 days) and every 6-12 months as clinically indicated. ]Overall response includes complete remission (CR) and partial remission (PR). Patients are considered non-responders if there is progression of disease.
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): NCT01002755
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Alessandra Ferrajoli, MD||M.D. Anderson Cancer Center|