clinical trial · NCT07223190
A Study Evaluating Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults With B-cell Precursor Acute Lymphoblastic Leukaemia
Amgen·phase3·not yet recruiting·n = 560
Philadelphia Chromosome Negative B-cell Precursor Acute Lymphoblastic LeukemiaBlinatumomabBlinatumomabHyperCVAD
brief 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.
started
Jun 11, 2026
primary completion
May 10, 2030
completion
Aug 9, 2033
last updated
Mar 4, 2026
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol