CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 41 enrolled
Drug / intervention
Blinatumomabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02910063
NCT02910063Phase 3Completed

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

Amgen·interventional·Posted Sep 21, 2016·Updated Jan 13, 2021

In Brief

A Phase 3 clinical trial evaluating Blinatumomab for B-Cell Non Hodgkin Lymphoma. Completed, enrolled 41 participants across 31 sites in 8 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Belgium, Canada, Italy, Puerto Rico, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 21, 2016
Enrollment StartJan 23, 2017
Primary CompletionMar 12, 2020
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 9.8 years ago

Interventions

Blinatumomabdrug

Blinatumomab monotherapy