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

• Status: Completed
• Trial end date: 2019-01-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen Research (Munich) GmbH
• Treatments: Antibodies, Bispecific; Blinatumomab

Criteria

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 tyrosine-kinase inhibitors (TKI)

• 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