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

Amgen

Status and phase: Completed; Phase 2

Conditions: B-cell Acute Lymphoblastic Leukemia

Treatments: Drug: Blinatumomab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01207388

MT103-203

Details and patient eligibility

About

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.

Full 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.

Enrollment: 116 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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116 participants in 1 patient group

Blinatumomab

Experimental group

Description:

Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.

Treatment:

Drug: Blinatumomab