A Confirmatory Multicenter, Single-arm Study to Assess the Efficacy, Safety, and Tolerability of the BiTE Antibody Blinatumomab in Adult Patients With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (BLAST)
Active, no longer recruiting
Phase of Trial: Phase II
Latest Information Update: 14 Feb 2018
At a glance
- Drugs Blinatumomab (Primary)
- Indications Precursor cell lymphoblastic leukaemia-lymphoma
- Focus Registrational; Therapeutic Use
- Acronyms BLAST
- Sponsors Amgen
- 14 Feb 2018 According to Amgen media release, data from this trial will be supporting the BLINCYTO (blinatumomab) supplemental Biologics License Application (sBLA) for the treatment of patients with minimal residual disease (MRD)-positive B-cell precursor acute lymphoblastic leukemia (ALL).The sBLA for BLINCYTO was accepted by the FDA for priority review, and a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2018 has been set
- 22 Jan 2018 Results assessing minimal residual disease response published in the Blood.
- 05 May 2017 This trial has been completed in Spain as per European Clinical Trials Database record.