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

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
• •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