Study to Evaluate Safety and Efficacy of Blinatumomab in Subjects With Relapsed/Refractory (R/R) Aggressive B-Cell NHL

Official Title

A Phase 2/3 Multi-centre Study to Evaluate the Safety and Efficacy of Blinatumomab in Subjects With Relapsed/Refractory Aggressive B-Cell Non Hodgkin Lymphoma

Summary:

This is a phase 2/3 open label, multicentre 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.

Trial Description

Primary Outcome:

  • Phase 2 and 3- Complete Metabolic Response
  • Phase 3- Complete Metabolic Response
Secondary Outcome:
  • Phase 3 - Overall Survival
  • Phase 2 Objective Response Rate
  • Phase 2 Progression-Free Survival
  • Phase 2 Duration of Response
  • Phase 2 Successful Mobilization Rate
  • Phase 2 Hematopoietic Stem Cell Transplant rates (both autologous and allogeneic)
  • Phase 2 100 Day non-relapse mortality after autologous HSCT
  • Phase 2 Blinatumomab concentration steady state
  • Phase 2 Incidence and severity of adverse events
  • Phase 3 Objective response rate
  • Phase 3 Progression-Free Survival
  • Phase 3 Duration of Response
  • Phase 3 Successful Mobilization Rate
  • Phase 3 Hematopoietic Stem Cell Transplant rates (both autologous and allogeneic)
  • Phase 3 Patient-reported clinical outcome assessments
  • Phase 3 Blinatumomab concentration steady state
  • Phase 3 Overall incidence and severity of treatment-emergent adverse events
  • Phase 2 Blinatumomab clearance
  • Phase 2 Blinatumomab half life
  • Phase 3 Blinatumomab clearance
  • Phase 3 Blinatumomab half life
This is a phase 2/3 open label, multicentre trial testing blinatumomab monotherapy for the treatment of subjects with R/R aggressive B-NHL not achieving CMR after 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 IC chemotherapy.The phase 2 component of the study will consist of up to a 28-day screening period, approximately 70 to 112 days of study treatment, a 30-day (+/- 3days) safety follow up, and long-term follow up that will conclude with the final analysis of the phase 3 component, estimated at 30 months after initiation of the phase 3 component. For the phase 3 component, the study will consist of up to a 28-day screening period, a treatment period of up to approximately 168 days, a 30-day safety follow-up visit, and long-term follow up. Long-term follow up will conclude with the final analysis.In the phase 2 component, enrolled subjects will receive blinatumomab monotherapy. In the phase 3 component, enrolled subjects will be randomized in a 1:1 ratio to blinatumomab or IC chemotherapy.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society