NCT07223190

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

A Phase 3, Open-label, Randomized, Controlled Trial of Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults With Philadelphia Chromosome Negative B-cell Precursor Acute Lymphoblastic Leukaemia

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 560 (estimated)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Philadelphia Chromosome Negative B-cell Precursor Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	Blinatumomab	Blinatumomab will be administered as a SC injection.
DRUG	Blinatumomab	Blinatumomab will be administered as a cIV infusion.
DRUG	HyperCVAD	HyperCVAD will administer as the chemo regimen as part of the standard of care (SOC) regimen.

Timeline

• Start date: 2026-06-11
• Primary completion: 2030-05-10
• Completion: 2033-08-09
• First posted: 2025-10-31
• Last updated: 2026-03-04

Regulatory

• FDA-regulated drug study