Urelumab (CD137 mAb) With Rituximab for Relapsed, Refractory or High-risk Untreated Chronic Lymphocytic Leukemia (CLL) Patients
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|ClinicalTrials.gov Identifier: NCT02420938|
Recruitment Status : Withdrawn
First Posted : April 20, 2015
Last Update Posted : December 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: Rituximab Drug: Urelumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Urelumab (CD137 mAb) Combined With Rituximab for Relapsed, Refractory or High-risk Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||July 2020|
Experimental: Rituximab + Urelumab
Participants receive Rituximab 375 mg/m2 by vein weekly for the first 4 weeks (Days 1, 8, 15, 22) then the day prior to each subsequent dose of Urelumab for the 12-week course. Urelumab 8 mg by vein given every 3 weeks for 4 doses, starting Day 2 of the course. Urelumab doses administered approximately 24 hours after the Rituximab doses. Up to two 12-week courses of treatment administered (total of maximum 12 doses of Rituximab and 8 doses of Urelumab).
375 mg/m2 by vein weekly for the first 4 weeks (Days 1, 8, 15, 22) then the day prior to each subsequent dose of Urelumab for the 12-week course.
Other Name: Rituxan
8 mg by vein given every 3 weeks for 4 doses, starting Day 2 of the 12-week course.
- Overall Response (OR) of Urelumab and Rituximab in Participants with High-Risk Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL). [ Time Frame: 12 weeks ]Response assessed by investigator, based on physical examinations, CT scans, laboratory results, and bone marrow examinations, based on modified 2008 IWCLL criteria for response for chronic lymphocytic leukemia (CLL). Overall response (OR) includes complete remission (CR), CR with incomplete marrow recovery (CRi) or partial remission (PR). Minimal residual disease (MRD) assessed in bone marrow by multi-color flow cytometry.
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): NCT02420938
|Principal Investigator:||Nitin Jain, MBBS||M.D. Anderson Cancer Center|