NCT01207388

Confirmatory Phase II Study of Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia (ALL)

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Amgen Research (Munich) GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to confirm whether the bispecific T cell engager blinatumomab (MT103) is effective, safe and tolerable in the treatment of ALL patients with minimal residual disease.

Detailed description

The detection of minimal residual disease (MRD) after induction therapy and/or consolidation therapy is an independent prognostic factor for poor outcome of adult ALL. No standard treatments are available for patients with MRD-positive B-precursor ALL. Blinatumomab (MT103) is a bispecific single-chain antibody construct designed to link B cells and T cells resulting in T-cell activation and a cytotoxic T-cell response against cluster of differentiation (CD)19 expressing cells. The purpose of this study is to confirm whether the bispecific T-cell engager blinatumomab (MT103) is effective, safe and tolerable in the treatment of ALL patients with minimal residual disease. Participants will receive up to four 4-week cycles of intravenous blinatumomab treatment followed by an infusion-free period of 14 days. A safety follow-up will be performed 30 days after the end of the last infusion and efficacy follow-ups will occur until 24 months after treatment start. Participants will be followed for up to 5 years after the start of treatment for survival.

Conditions

• B-cell Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	Blinatumomab	Continuous intravenous infusion

Timeline

• Start date: 2010-11-01
• Primary completion: 2014-02-01
• Completion: 2019-01-07
• First posted: 2010-09-22
• Last updated: 2020-02-10
• Results posted: 2015-02-12

Locations

75 sites across 11 countries: Austria, Belgium, France, Germany, Italy, Netherlands, Poland, Romania, Russia, Spain, United Kingdom