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NOT YET RECRUITING
NCT07223190
PHASE3

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

Sponsor: Amgen

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

560

Start Date

2026-06-11

Completion Date

2033-08-09

Last Updated

2026-03-04

Healthy Volunteers

No

Interventions

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.