Blinatumomab in Adults With Relapsed/Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia

This is a single-arm Simon II stage design, multicenter study consisting of a screening
period, an induction treatment period (2 cycles of blinatumomab), a consolidation treatment
period (up to 3 additional cycles of blinatumomab for applicable participants), and a safety
follow-up visit 30 days after treatment. Following the safety follow-up visit, participants
will be followed for response duration and survival every 3 months for 18 months or death,
whichever occurs first.

Inclusion Criteria

- Patients with Ph+ B-precursor ALL, with any of the following:

- Relapsed or refractory to at least one second generation tyrosine kinase
inhibitor (TKI) (dasatinib, nilotinib, bosutinib, ponatinib)

- OR intolerant to second generation TKI and intolerant or refractory to imatinib
mesylate

- Greater than 5% blasts in bone marrow

- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

- Age ≥ 18 years of age, at the time of informed consent.

- Subject has provided informed consent or subject's legally acceptable representative
has provided informed consent when the subject has any kind of condition that, in the
opinion of the Investigator, may compromise the ability of the subject to give written
informed consent.

Exclusion Criteria

- History of malignancy other than ALL within 5 years prior to start of
protocol-required therapy, except for adequately treated selected cancers without
evidence of disease

- History or presence of clinically relevant central nervous system (CNS) pathology as
epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries,
dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis

- Active ALL in the CNS or testes

- Isolated extramedullary disease

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

- Allogeneic hematopoietic stem cell transplantation (HSCT) within 12 weeks before
blinatumomab treatment

- Active acute or extensive chronic graft-versus-host disease (GvHD) which included the
administration of immunosuppressive agents to prevent or treat GvHD within 2 weeks
before blinatumomab treatment

- immediately previous cancer chemotherapy, radiotherapy, or immunotherapy; and
eligibility for allogeneic HSCT at the time of enrollment.