Study to Evaluate Safety and Efficacy of Blinatumomab in Subjects with Relapsed/Refractory (R/R) Aggressive B-Cell NHL
Study Details
This is a phase 2/3 open label, multicenter trial testing blinatumomab monotherapy for the treatment of subjects with Relapsed/Refractory (R/R) aggressive B-NHL not achieving CMR after 2 cycles of standard platinum-based chemotherapy regimens administered as S1. This study incorporates multiple interim analyses for futility, efficacy, and unblinded sample-size re-estimation. In the phase 3 part of the study, blinatumomab will be compared to Investigator's Choice chemotherapy.
In March 2019, decision made to not proceed with phase 3.
Protocol Summary
Phase 2 Complete Metabolic Response
Timeframe: Approximately 70 days after initiating blinatumomab.
Phase 2 Objective Response Rate
Timeframe: Approximately 30 months
Phase 2 Progression-Free Survival
Timeframe: Approximately 30 months
Phase 2 Duration of Response
Timeframe: Approximately 30 months
Phase 2 Successful Mobilization Rate
Timeframe: Approximately 30 months
Phase 2 Hematopoietic Stem Cell Transplant rates (both autologous and allogeneic)
Timeframe: Approximately 30 months
Phase 2 100 Day non-relapse mortality after autologous HSCT
Timeframe: 100 days after autologous HSCT
Phase 2 Blinatumomab concentration steady state
Timeframe: Approximately 70 days post initiation of blinatumomab
Phase 2 Incidence and severity of adverse events
Timeframe: Approximately 2 Years after treatment
Phase 2 Blinatumomab clearance
Timeframe: Approximately 70 days post initiation of blinatumomab
Phase 2 Blinatumomab half life
Timeframe: Approximately 70 days post initiation of blinatumomab