A Multi-center Phase I/Ib Study Evaluating the Efficacy and Safety of Ublituximab, a Third- Generation Anti-CD20 Monoclonal Antibody, in Combination with TGR-1202, a Novel PI3k Delta Inhibitor and Ibrutinib in Patients with B-cell Malignancies.
The goal of this clinical research study is to learn the highest tolerable dose of the combination of ublituximab and TGR-1202 or the combination of ublituximab, TGR-1202, and ibrutinib that can be given to patients with B-cell lymphoma. The safety of this study drug combination will also be studied.
Treatment Location: N/A
Primary Objectives To evaluate the safety, and determine the dose limiting toxicities (DLT’s) and the maximum tolerated dose (MTD) of ublituximab in combination with TGR-1202 in patients with B-cell lymphoma To evaluate the safety, and determine the DLT’s and MTD of ublituximab + TGR-1202 + ibrutinib in patients with B-cell lymphoma Secondary Objectives To determine the overall response rate (ORR) defined as the sum of complete responses (CR) and partial responses (PR), progression-free survival (PFS), and duration of response (DOR) in patients with B-cell lymphoma.
IRB Review and Approval Date: 08/21/2014
Recruitment Status: Closed
Projected Accrual: N/A
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