Study Complete
Sponsor ID
20150292

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

Sponsor ID
20150292
Clinicaltrials.gov ID
NCT02910063
EUCTIS ID
N/A
EudraCT ID
2016-002044-16

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.

Additional Study Details

Phase
Phase 2/Phase 3
Product
blinatumomab
Type
Interventional
Masking
None (Open Label)
Enrollment
41
Additional Study Details

Protocol Summary

Primary Outcome Measures

Phase 2 Complete Metabolic Response

Timeframe: Approximately 70 days after initiating blinatumomab.

Secondary Outcome Measures

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

Locations

Location
Status
Contact Us
Location
Research Site
Greenville, SC, United States, 29607
Status
Recruiting
Location
Research Site
Bristol, United Kingdom, BS2 8ED
Status
Recruiting
Location
Research Site
Nottingham, United Kingdom, NG5 1PB
Status
Recruiting
Location
Research Site
Sheffield, United Kingdom, S10 2JF
Status
Recruiting
Location
Research Site
Gent, Belgium, 9000
Status
Recruiting
Location
Research Site
Bruxelles, Belgium, 1200
Status
Recruiting
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