Clinical Trial

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

Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 3 changes
minor Completion pushed: 2031-05-12 -> 2031-06-30 2026-07-01
critical Trial status changed: RECRUITING → ACTIVE_NOT_RECRUITING 2026-05-21
minor Completion moved earlier: 2031-07-01 -> 2031-05-12 2026-05-21
Trial Details
NCT Number NCT04994717
Lead Sponsor Amgen
Conditions Newly Diagnosed Philadelphia (Ph)-Negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL)
Enrollment 303 participants
Start Date 2021-11-02
Primary Completion 2029-09-07 (estimated)
Study Completion 2031-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-30