Lenalidomide and Ofatumumab in Treating Participants With Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
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|ClinicalTrials.gov Identifier: NCT01002755|
Recruitment Status : Completed
First Posted : October 27, 2009
Results First Posted : May 7, 2019
Last Update Posted : May 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia Fatigue Fever Hypogammaglobulinemia Lymphadenopathy Lymphocytosis Night Sweats Paraproteinemia Small Lymphocytic Lymphoma Thrombocytopenia||Drug: Lenalidomide Biological: Ofatumumab||Phase 2|
I. To evaluate efficacy and tolerability of the combination of ofatumumab and lenalidomide in patients with recurrent chronic lymphocytic leukemia (CLL).
Participants receive ofatumumab intravenously (IV) over 4 hours on days 1, 8, 15, and 22 of course 1, day 1 of courses 2-6, and day 1 of every even course beginning course 8. Beginning day 9 of course 1, participants also receive lenalidomide orally (PO) daily. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up at 6 months, then every 3 months thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 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: Treatment (lenalidomide, ofatumumab)
Participants receive ofatumumab IV over 4 hours on days 1, 8, 15, and 22 of course 1, day 1 of courses 2-6, and day 1 of every even course beginning course 8. Beginning day 9 of course 1, participants also receive lenalidomide PO daily. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
- Overall Response Rate [ Time Frame: Up to 8 years ]A Simon's two-stage minmax design will be used. Includes complete remission (CR) and partial remission (PR). Complete Response Requires the absence of disease signs and symptoms, and normalization of Peripheral blood and bone marrow. Partial Response it at lease a 50% reduction in disease signs and symptoms and normalization of peripheral blood.
- Number of Participants With Tolerance of the Medication Combination [ Time Frame: Up to 8 years ]Incidence of grade 3 and 4 non-hematological toxicity in more than 50 percent of the participants. Will be monitored based on the Bayesian model (beta-binomial).
- Progression Free Survival [ Time Frame: Up to 8 years ]The time from the start of therapy to death, disease progression, or the initiation of the next therapy. Disease progression is the loss of response or transformation to a more aggressive histology.
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|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Alessandra Ferrajoli||M.D. Anderson Cancer Center|