Study Comparing Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care Chemotherapy for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia

• Drug: Blinatumomab
• Drug: Low-intensity chemotherapy regimen
• Drug: SOC chemotherapy regimen

Inclusion Criteria:

– Age ≥ 55 years at the time of informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment.. OR

Age 40 to < 55 years of age if at least 1 of the following comorbidities at the time of informed consent:

• history of grades 3 and 4 pancreatitisinflammation of the pancreas
• diabetes mellitus with end-organ damage
• severe liver disease such as cirrhosis stage 2 with portal hypertensionhigh blood pressure or history of esophageal variceal bleeding and aspartate transaminase (AST)/alanine aminotransferase (ALT) > 10 x upper limit of normal (ULN) (liver cirrhosis must be confirmed by biopsyremoval of a section of tissue to analyse for cancer cells)
• body massa growth of cells that come together to make a lump, may or may not be cancer index (BMI) ≥ 40 combined with relevant comorbidities such as metabolic syndrome
• Any further combination of documented severe comorbidities that the investigator judges to be incompatible with administering an intensive pediatric based, adult adapted standard chemotherapy regimen but still compatible with the suggested protocol for older participants in both the experimental and the SOC arm. The participant history will be reviewed by the medical monitorto check on, keep track of during screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening to determine enrollment acceptability based on a standard list with types of comorbidities allowed. A medical advisory board is available to the investigators for questions/advice and includes experts in the field of adult leukemia with experience with the use of blinatumomab, the global development lead for blinatumomab and the medical monitor of the study.
  • Participants with newly diagnosed Philadelphia (Ph)-negative B-cell precursor acutenew, recent, comes with an urgent or significant sense, is sudden, sharp lymphoblastic leukemia (ALL)
  • Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status ≤ 2, higher ECOG score allowed if due to underlying leukemia
  • All participants must have adequate organ function as defined below:
• renal: estimated glomerular filtration rate based on MDRD calculation ≥ 50 mL/min/1.73 m^2
• liver function: total bilirubin ≤ 2x upper limit of normal (ULN; unless Gilbert’s Disease or if liver involvement with leukemia); exception for participants 40 to < 55 years of age if they have a comorbidity listed above: severe liver disease such as cirrhosis stage 2 with portal hypertension or history of esophageal variceal bleeding and AST/ALT > 10 x ULN (liver cirrhosis must be confirmed by biopsy)
• cardiac: left ventricular ejection fraction (LVEF) ≥ 50%