Clinical Trial

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

Study acronym: AUDAX
Not Yet Recruiting Phase 3
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-10-29.
Trial Details
NCT Number NCT07223190
Lead Sponsor Amgen
Conditions Philadelphia Chromosome Negative B-cell Precursor Acute Lymphoblastic Leukemia
Enrollment 560 participants
Start Date 2026-06-11
Primary Completion 2030-05-10 (estimated)
Study Completion 2033-08-09 (estimated)
Updated on ClinicalTrials.gov 2026-03-04