A Randomized 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 with Safety Run-in (Golden Gate Study)

You may be able to join if

• Subject has provided informed consent prior to initiation of any study specific activities/procedures OR Where permitted by local law, subject’s legally acceptable representative has provided informed consent prior to any study-specific activities/procedures being initiated 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.
• Age ≥ 55 years at the time of informed consent 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 pancreatitis - diabetes mellitus with end-organ damage - severe liver disease such as cirrhosis stage 2 with portal hypertension or history of esophageal variceal bleeding and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 10 x upper limit of normal (ULN) (liver cirrhosis must be confirmed by biopsy) - body mass 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 subjects in both the experimental and the SOC arm. The subject history needs to be reviewed by the medical monitor during screening to determine enrollment acceptability based on a standard list with types of comorbidities allowed.
• Subjects with newly diagnosed Philadelphia (Ph)-negative B-cell precursor acute lymphoblastic leukemia (ALL) per WHO criteria
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, higher ECOG score allowed if due to underlying leukemia.
• All subjects must have adequate organ function as defined below: - renal: estimated glomerular filtration rate based on Modification of Diet in Renal Disease (MDRD) calculation ≥ 50 mL/min/1.73 m2 - liver function: total bilirubin ≤ 2x upper limit of normal (ULN; unless Gilbert’s Disease or if liver involvement with leukemia); exception for subjects 40 to < 55 years of age if comorbidity is per inclusion 102: 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% and no clinically significant, uncontrolled, or active cardiovascular disease (eg, myocardial infarction or stroke within 3 months). Consult with medical monitor as needed.