Overview

This trial is active, not recruiting.

Condition b-cell acute lymphoblastic leukemia
Treatment blinatumomab
Phase phase 2
Target CD19
Sponsor Amgen Research (Munich) GmbH
Start date November 2010
End date February 2014
Trial size 116 participants
Trial identifier NCT01207388, MT103-203

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Participants received blinatumomab as a continuous intravenous infusion at constant flow rate of 15 μg/m²/day over 28 days per treatment cycle followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
blinatumomab AMG103
Continuous intravenous infusion

Primary Outcomes

Measure
MRD response rate
time frame: within 6 weeks

Secondary Outcomes

Measure
Hematological relapse-free survival rate
time frame: 18 months
Overall survival
time frame: 5 years
Duration of complete MRD response
time frame: 2 years
Overall incidence and severity of AEs
time frame: until EoS
Quality of Life
time frame: until EoS

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients with B-precursor ALL in complete hematological remission after at least 3 intense chemotherapy blocks - Presence of minimal residual disease at a level of ≥ 10^-3 - Availability of bone marrow specimen from primary diagnosis for clone-specific MRD assessment - Negative human immunodeficiency virus (HIV) test, negative hepatitis B (HbsAg) test and hepatitis C virus (anti-HCV) test - Negative pregnancy test in women of childbearing potential - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Exclusion Criteria: - Presence of circulating blasts or current extra-medullary involvement by ALL - History of relevant central nervous system (CNS) pathology or current CNS pathology - Prior allogeneic hematopoietic stem cell transplant (HSCT) - Eligibility for treatment with TKIs - Systemic cancer chemotherapy within 2 weeks prior to study treatment - Therapy with monoclonal antibodies (rituximab, alemtuzumab) within 4 weeks prior to study treatment - Previous treatment with blinatumomab

Additional Information

Official title 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)
Principal investigator Ralf Bargou, MD
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 CD19 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. Patients will receive up to four 4-week cycles of intravenous blinatumomab treatment.
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Amgen Research (Munich) GmbH.