drugset / Trial / NCT07223190

A Study Evaluating Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults With B-cell Precursor Acute Lymphoblastic Leukaemia

NCT07223190

Phase 3 Not yet recruiting 560 enrolled Amgen
RandomizedParallel-groupOpen-labelTreatment

Summary

The main objective of this trial is to demonstrate that subcutaneous (SC) blinatumomab in conjunction with chemotherapy (Arm B) is non-inferior to continuous intravenous infusion (cIV) blinatumomab in conjunction with chemotherapy (Arm A) in overall survival (OS) in newly diagnosed participants with Philadelphia chromosome (Ph) negative B-cell precursor acute lymphoblastic leukemia (B-ALL) who are in complete remission (CR) or CR with incomplete peripheral count recovery (CRi) after induction.

Timeline

Start
2026-06-11
Primary completion
2030-05-10
Completion
2033-08-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Blinatumomab Monoclonal antibody Subcutaneous