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

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