Study of the BiTE® Blinatumomab (MT103) in Adult Patients With Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL)

Amgen

Status and phase: Completed; Phase 2

Conditions: B-ALL

Treatments: Biological: Blinatumomab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01209286

MT103-206

Details and patient eligibility

About

The purpose of this study is to determine whether the bispecific T-cell engager blinatumomab is effective, safe and tolerable in the treatment of patients with relapsed/refractory B-precursor ALL.

Full description

Relapsed/refractory B-precursor ALL in adult patients is an aggressive malignant disease with dismal prognosis and unmet medical need. Additional therapeutic approaches are urgently needed. Blinatumomab 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 investigate the efficacy, safety and tolerability of different doses of the bispecific T-cell engager blinatumomab in adult patients with relapsed/refractory B-precursor ALL. Patrticipants will receive up to five 4-week cycles of intravenous blinatumomab treatment.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with B-precursor ALL relapsed after at least induction and consolidation or having refractory disease
• More than 5% blasts in bone marrow
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• Life expectancy of ≥ 12 weeks

Exclusion criteria

• History or presence of clinically relevant central nervous system (CNS) pathology
• Infiltration of cerebrospinal fluid (CSF) by ALL
• Autologous/allogeneic hematopoietic stem cell transplantation (HSCT) within six weeks/three months prior to start of blinatumomab treatment
• Active Graft-versus-Host Disease (GvHD)
• Patients with Philadelphia chromosome (Ph)+ ALL eligible for treatment with dasatinib or imatinib
• Cancer chemotherapy within two weeks prior to start of blinatumomab treatment
• Immunotherapy (e.g. rituximab) within four weeks prior to start of blinatumomab treatment
• Infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive)
• Pregnant or nursing women
• Previous treatment with blinatumomab

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

Blinatumomab 15 μg

Experimental group

Description:

Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.

Treatment:

Biological: Blinatumomab

Blinatumomab 5/15 μg

Experimental group

Description:

Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.

Treatment:

Biological: Blinatumomab

Blinatumomab 5/15/30 μg

Experimental group

Description:

Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.

Treatment:

Biological: Blinatumomab