Treatment of Chronic Lymphocytic Leukemia in Patients Previously Exposed to Rituximab
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|ClinicalTrials.gov Identifier: NCT01123356|
Recruitment Status : Completed
First Posted : May 14, 2010
Results First Posted : December 3, 2015
Last Update Posted : December 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia||Drug: Ofatumumab Drug: Lenalidomide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Trial of Intracycle Sequential Ofatumumab and Lenalidomide for the Treatment of Chronic Lymphocytic Leukemia in Patients Previously Exposed to Rituximab|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||June 2013|
Experimental: Oratumumab and Lenalidomide
Single arm, non randomized study
Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.
Other Name: Arzerra
-Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28 for up to 6 cycles (28 day cycles)
Other Name: Revlimid
- Overall Response Rate [ Time Frame: 30 Weeks ]
Obtain early assessment of the efficacy of the intracycle sequential administration of ofatumumab and lenalidomide in the treatment of chronic lymphocytic leukemia (CLL) after prior use of rituximab. Response was categorized according to the IW-CLL criteria which includes the following: Complete remission (CR), CR with incomplete marrow recovery (CRi)Partial remission (PR), Progressive disease (PD), Stable disease (SD).
Overall response rate was defined as those who experienced a response of CR, CRi or PR.
- Frequency of Adverse and Severe Adverse Events [ Time Frame: 30 weeks ]Frequency of adverse and severe adverse events
- Biomarkers Changes During Treatment. [ Time Frame: 30 Weeks ]Biomarkers changes during treatment. A minimum of 5 subjects will be enrolled in the biomarkers sub-study. Only those subjects enrolled at MUSC will be considered for the biomarkers sub-study. At day 1 of cycle 1, day 8 of cycle 1, day 1 of cycle 2 and day 8 of cycles 2, blood samples will be obtained for assessment of biomarkers.
- Frequency of Adverse Events [ Time Frame: 30 weeks ]Number of adverse events occuring in greater than 20% of subjects
- Dose Reductions Due to Adverse Events. [ Time Frame: 30 weeks ]Number of dose reductions due to toxicity.
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): NCT01123356
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Greenville Hospital System|
|Greenville, South Carolina, United States, 29605|