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Blinatumomab

The safety run-in will be performed prior to initiating the phase 3 randomized part of the study. This safety run-in is to evaluate the safety and tolerability of blinatumomab alternating with low-intensity chemotherapy.

The safety run-in also evaluates a shorter dose step interval from (4 days instead of 7 days) and a 1-week (instead of 2-week) drug free interval between blinatumomab cycles. Blinatumomab will be infused at a lower dose for 4 days and increase to a higher dose on Day 5 of the infusion for the remainder of the infusion.

Participants will receive blinatumomab alternating with low-intensity chemotherapy.

Participants will receive 1 of 2 SOC chemotherapy regimens (GMALL or HyperCVAD) per investigator's choice.

Intravenous (IV), oral (PO), subcutaneous (SC), or intrathecal (IT) administration.

Low-intensity chemotherapy regimen

SOC chemotherapy regimen

Amgen Call Center

The safety run-in part of the study aims to evaluate the safety and tolerability of blinatumomab alternating with low-intensity chemotherapy. The phase 3 part of the study aims to compare event-free survival (EFS) and overall survival (OS) of participants receiving blinatumomab alternating with low-intensity chemotherapy to EFS and (OS) of participants receiving standard of care (SOC) chemotherapy.

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

Phase 3 Randomized, Controlled Study of Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia With Safety Run-in (Golden Gate Study)

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Number and percentage of participants who experience one or more TEAE, serious TEAE, treatment-related adverse events, and adverse events of interest.

Time from randomization (enrollment) until treatment failure, relapse or death from any cause, whichever is earlier.

Treatment failure is defined as not achieving a hematological complete CR with MRD response \<10-4 by the end of the initial disease assessment period.

Relapse is defined as hematologic relapse, extramedullary relapse, and/or molecular relapse (MRD positivity \>= 10\^-3), whichever occurs earlier, in participants with prior achievement of hematologic CR with MRD response \<10\^-4.

Participants without an event will be censored at their last evaluable disease assessment date.

OS is defined as time from randomization (enrollment) until death due to any cause.

MRD response is defined as the percentage of participants who achieve a response of \< 10\^-4 measured by polymerase chain reaction (PCR).

RFS: In participants who achieve CR, the time from first achievement of this response until date of the first relapse including hematologic relapse, extramedullary relapse, or death due to any cause, whichever occurs first.

MRD RFS: In participants who achieve CR with MRD response, the time from first achievement of this response until date of of the first relapse including molecular relapse, hematological relapse, and/or extramedullary relapse, or death due to any cause, whichever occurs first. (Molecular relapse will be defined 2 ways: MRD\>= 10\^-3 and MRD\>=10\^-4. Participants without an event will be censored at their last evaluable disease assessment date.

Fatigue score will be measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue - Short Form 7a.

Pain score will be measured by Brief Pain Inventory - Short Form (BPI-SF); Item 3: pain at its worst in the last 24 hours.

Global health status will be measured by the Quality of Life Questionnaire (QLQ)-C30 global health status quality of life scale.

Physical function will be measured by the QLQ-C30 functional scale.

Nausea and vomiting will be measured by the QLQ-C30 symptom scale.

MRD response is defined as the percentage of participants who achieve a response of \< 10\^4 measured by polymerase chain reaction (PCR).

RFS: In participants who achieve CR, the time from first achievement of this response until the date of the first relapse including hematologic relapse, extra medullary relapse, or death due to any cause, whichever occurs first. Participants without an event will be censored at their last evaluable disease assessment date.

In participants who achieve CR with MRD response, the time from first achievement of this response until date of the first relapse including molecular relapse, hematologic relapse, and/or extramedullary relapse, or death due to any cause, whichever occurs first. Molecular relapse will be defined 2 ways: MRD\>= 10\^-3 and MRD\>= 10\^-4. Participants without an event will be censored at their last evaluable disease assessment date

Fatigue score will be measured by PROMIS Fatigue-Short Form 7a.

Pain score will be measured by BPI-SF; Item 3: pain at its worst in the last 24 hours.

EORTC QLQ-C30 will include global health status, physical functioning, emotional functioning, cognitive functioning, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, diarrhea, and financial difficulties will be measured by EORTC QLQ-C30.

Global health status, physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, diarrhea, and financial difficulties will be measured by EORTC QCQ-C30.

Spots Global Cancer Trial Database for gmall hypercvad