Trial intelligence / Profile preview

Blinatumomab in Ph+ R/R ALL (ALCANTARA)

NCT02000427Phase 2

Key facts

Status: Completed
Start: Jan 2014
Primary completion: May 2015
Countries: 5
Sponsor: Amgen
Modality: Antibody Conjugates, scFv Fragments, Bispecific Antibodies

Drugs: blinatumomab
Conditions: B cell acute lymphoblastic leukemia (B-ALL)

Overview

Phase 2, open-label, single-arm trial of blinatumomab in B cell acute lymphoblastic leukemia (B-ALL), sponsored by Amgen. Primary endpoint: Complete Remission/Complete Remission with Partial Hematological Recovery at 12 weeks. Started Jan 2014; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Blinatumomab
Continuous intravenous infusion of Blinatumomab

Who it enrols

Adults with Ph+ B-precursor ALL who are relapsed or refractory to at least one second-generation TKI or intolerant to second-generation TKIs and imatinib.

Endpoints

Primary

Complete Remission/Complete Remission with Partial Hematological Recovery12 weeks

Secondary

Minimal Residual Disease Remission12 weeks
Duration of CR or CRh* Response7.0 months
Complete Remission12 weeks
Complete Remission with Partial Hematological Recovery12 weeks
Overall Survival8.8 months
Rate of Allogeneic HSCT14.5 months
Adverse Events30 days post-treatment
Anti-blinatumomab Antibodies30 days post-treatment

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