drugset / Trial / NCT04994717

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

NCT04994717

Phase 3 Active not recruiting 303 enrolled Amgen
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2021-11-02
Primary completion
2029-09-07
Completion
2031-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Blinatumomab Monoclonal antibody Intravenous