Trial intelligence / Profile preview

Blinatumomab in Pediatric Relapsed/Refractory B-Precursor ALL

NCT01471782Phase 2

Key facts

Status: Completed
Start: Jan 2012
Primary completion: Aug 2014
Countries: 7
Sponsor: Amgen
Modality: Antibody Conjugates, scFv Fragments, Bispecific Antibodies

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

Overview

Phase 2, open-label trial of blinatumomab in B cell acute lymphoblastic leukemia (B-ALL), sponsored by Amgen. Primary endpoints: Dose-limiting Toxicities at 28 days and Complete Remission Rate at 12 weeks. Started Jan 2012; status: completed.

Design

Study design: Non-randomizedOpen-label

Who it enrols

Pediatric and adolescent patients (<18 years) with relapsed/refractory B-precursor ALL (>25% blasts), adequate organ function, and performance status >= 50%. Excludes active GvHD, CNS pathology/involvement, and recent prior therapies.

Endpoints

Primary

Dose-limiting Toxicities28 days
Complete Remission Rate12 weeks

Secondary

Adverse EventsUp to 30 days after last dose
Steady State Concentration of BlinatumomabCycles 1 and 2
Time to Hematological RelapseUp to 24 months
Overall SurvivalUp to 24 months
Relapse-free SurvivalUp to 24 months
HSCT Realization RateUp to 24 months
Anti-drug AntibodiesUp to 30 days after last dose
Serum Cytokine Peak LevelsCycles 1 and 2

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