Facilitated By

San Antonio Medical Foundation

A Phase 2B Randomized Study To Assess The Efficacy And Safety Of The Combination Of Ublituximab + TGR-1202 With Or Without Bendamustine And TGR-1202 Alone In Patients With Previously Treated Non-Hodgkins Lymphoma

Brooke Army Medical Center

Brooke Army Medical Center (BAMC) at Fort Sam Houston, Texas, is proud to provide safe, quality care to our military service members, their families, veterans and civilian emergency patients as the most robust and productive healthcare organization within the Military Health System (MHS).

Principal Investigator(s)
Email for information
Funded by
Geneva
Research Start Date
Status
Active

This study is designed as a Phase 2b, randomized trial to evaluate the efficacy and safety of TGR-1202 alone and in combination with ublituximab with or without bendamustine in previously treated indolent non-Hodgkins lympoma (iNHL) and Diffuse Large B-Cell Lymphoma (DLBCL) patients. Following screening, qualified patients with Follicular Lymphoma ( FL) or Small Lymphocytic Lymphoma (SLL) will be randomized in a 1:1 ratio to one of two arms: Arm A: Ublituximab + TGR-1202, Arm B: TGR-1202. Up to approximately 100 patients will be enrolled into each arm, for a total of approximately 200 patients. Pursuant of an interim analysis, Arm B may be closed and Arm C (Ublituximab +TGR-1202 + Bendamustine) will be opened. For the Marginal Zone Lymphoma (MZL) Cohort, following screening, up to approximately 60 qualified patients will enroll and receive TGR-1202 monotherapy. For the DLBCL cohort, following Screening, qualified patients with DLBCL will be randomized in a 1:1 ratio to one of two arms: Arm A: Ublituximab + TGR-1202, Arm B: TGR-1202. Arm A: Ublituximab + TGR-1202, Arm B: TGR-1202.Pursuant to futility analysis, if Arm B is closed, Arm C (Ublituximab +TGR-1202 + Bendamustine) will be opened. During the study period, all patients will be evaluated for response as well as disease progression. All enrolled subjects will be treated for at least 6 months, after which time the study may end

Collaborative Project
Clinical Care
Cancer
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