Study to Investigate Intravenous Blinatumomab in Japanese Adult Participants With Newly Diagnosed Philadelphia-negative B-precursor Acute Lymphoblastic Leukemia (B-ALL)

Inclusion Criteria:

• Japanese adult participants ≥ 18 years and ≤ 70 years at enrollment.

• Participant should have newly diagnosed B-cell precursor (BCP)

• Philadelphia-negative ALL in CR/CRh after induction/consolidation therapy with anyMRD (+ or -).

• CR/CRh as defined in Section 11.10, Appendix 10 after induction and at any timeduring consolidation chemotherapy with ALL MRD2008/2019/2023 protocol regimen or 3blocks of Hyper-CVAD.

• Bone marrow function as defined below:

• Absolute neutrophil count (ANC) (Neutrophils) ≥500/μL

• Platelets ≥50.000/μL (transfusion permitted)

• Adequate renal and hepatic function:

• Total bilirubin (TBL) ≤ 2.0 x upper limit of normal (ULN) (ULN; unlessGilbert's Disease or if liver involvement with leukemia)

• Creatinine clearance ≥50 mL/min/1.73 m^2

• Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 2.

Exclusion Criteria:

Disease Related

• Current infiltration of cerebrospinal fluid (CSF) by ALL. If screening CSFdemonstrates leukemic blasts, participants must receive intrathecal treatment anddemonstrate negative CSF before enrollment and starting blinatumomab infusion.

• Immunotherapy (eg, rituximab, alemtuzumab) within 4 weeks before start ofprotocol-specified therapy.

Other Medical Conditions

• History of relevant central nervous system (CNS) pathology or current relevant CNSpathology (e.g., seizure, paresis, aphasia, cerebrovascular ischemia/hemorrhage,severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organicbrain syndrome, psychosis, or coordination or movement disorders).

• Current autoimmune disease or history of autoimmune disease with potential CNSinvolvement.

• Active uncontrolled infection requiring therapy.

• History of other malignancy within the past 3 years, with the following exceptions:

• Malignancy treated with curative intent and with no known active diseasepresent for ≥ 3 years before enrollment and felt to be at low risk forrecurrence by the treating physician.

• Adequately treated nonmelanoma skin cancer or lentigo maligna without evidenceof disease.

• Adequately treated cervical carcinoma in situ without evidence of disease.

• Adequately treated breast ductal carcinoma in situ without evidence of disease.

• Prostatic intraepithelial neoplasia without evidence of prostate cancer.

• Adequately treated urothelial papillary noninvasive carcinoma or carcinoma insitu.

Prior/Concomitant Therapy

• Systemic cancer chemotherapy within 2 weeks prior to study treatment (except forintrathecal prophylaxis)

• Known infection with human immunodeficiency virus (HIV) or chronic infection withhepatitis B virus or hepatitis C virus. In Japan, follow the JSH Guidelines for theManagement of Hepatitis B Virus Infection version 4 (The Japan Society ofHepatology, 2022) for the screening of Hepatis B virus infection.

• Radiotherapy within 4 weeks prior to study treatment.

Prior/Concurrent Clinical Study Experience

• Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). This does not apply to other investigational procedures or participation in observational research studies while participating in this study are excluded.

Other Exclusions

• Participants of childbearing potential unwilling to use protocol-specified method ofcontraception during treatment and for an additional 48 hours after the last dose ofblinatumomab.

• Participants who are breastfeeding or who plan to breastfeed while on study through 48 hours after the last dose of blinatumomab.

• Participants planning to become pregnant or donate eggs while on study through 48hours after the last dose of blinatumomab.

• Participants of childbearing potential with a positive pregnancy test assessed atscreening by a highly sensitive urine or serum pregnancy test.

• Participant has known hypersensitivity to blinatumomab or to any component of theproduct formulation.

• Participant likely to not be available to complete all protocol-required studyvisits or procedures, and/or to comply with all required study procedures (e.g.,Clinical Outcome Assessments) to the best of the participant and investigator'sknowledge.

• History or evidence of any other clinically significant disorder, condition, ordisease (except for those outlined above) that, in the opinion of the investigatoror Amgen physician, if consulted, would pose a risk to participant safety, orinterfere with the study evaluation, procedures, or completion.