Study of Blinatumomab in Japanese Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia

• Status: Completed
• Trial end date: 2019-07-04
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, combined 2-part multicenter study to evaluate the efficacy, safety, and tolerability of blinatumomab in adult and pediatric Japanese patients with relapsed/refractory B-precursor ALL.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Collaborator: Amgen Astellas Biopharma K.K.
• Treatments: Antibodies, Bispecific; Blinatumomab

Criteria

Adult Subjects Key Inclusion Criteria:

• Age ≥ 18 years old at enrollment

• Subjects with Philadelphia-negative B-precursor ALL, with any of the following:

• Relapsed or refractory after first line therapy with first remission duration ≤ 12 months; or

• Relapsed or refractory after first salvage therapy; or

• Relapsed or refractory within 12 months of allogeneic hematopoietic stem cell transplant (alloHSCT)

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.

• Greater than 5% blasts in bone marrow

Pediatric Subjects Key Inclusion Criteria:

• Age < 18 years old at enrollment

• Relapsed/refractory disease, defined as one of the following:

• second or later bone marrow relapse;

• any marrow relapse after alloHSCT; or

• Refractory to other treatments:

• For subjects in first relapse: failure to achieve a complete response (CR) following a full standard reinduction chemotherapy regimen

• For subjects who have not achieved a first remission: failure to achieve remission following a full standard induction regimen

• Greater than 5% blasts in bone marrow

• Karnofsky performance status ≥ 50% for subjects ≥ 16 years

• Lansky performance status ≥ 50% for subjects < 16 years

Key Exclusion Criteria

• Subjects with Burkitt´s Leukemia according to World Health Organization (WHO) classification

• History or presence of clinically relevant central nervous system (CNS) pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis; with the exception of well-controlled CNS leukemia

• Active ALL in the CNS or testes

• Current autoimmune disease or history of autoimmune disease with potential CNS involvement

• Autologous HSCT within 6 weeks prior to start of blinatumomab treatment

• AlloHSCT within 12 weeks prior to start of blinatumomab treatment

• Any active acute Graft-versus-Host Disease (GvHD) grade 2-4 according to Glucksberg criteria or active chronic GvHD requiring systemic treatment