Trial to Compare Efficacy and Safety of Chemotherapy/Quizartinib vs Chemotherapy/Placebo in Adults FMS-like Tyrosine Kinase 3 (FLT3) Wild-type Acute Myeloid Leukemia (AML)

Summary

Randomized phase II trial to compare the efficacy and safety of standard chemotherapy plus quizartinib versus standard chemotherapy plus placebo in adult patients with newly diagnosed FLT3 wild-type Acute Myeloid Leukemia

Timeline

Start

2019-09-05

Primary completion

2024-10-03

Completion

2025-01-24

Publications

• Montesinos P, Rodriguez-Veiga R, Bergua JM, Algarra Algarra JL, Botella C, Rodriguez-Arboli E, Bernal T, Tormo M, Calbacho M, Salamero O, Serrano J, Noriega V, Lopez-Lopez JA, Vives S, Lopez-Lorenzo JL, Colorado M, Vidriales MB, Garcia Boyero R, Olave MT, Herrera Puente P, Arce O, Barrios M, Jose Sayas M, Polo M, Gomez-Roncero MI, Barragan E, Ayala R, Chillon C, Calasanz MJ, Paiva B, Boluda B, Casas-Aviles I, Lloret-Madrid P, Sanchez MJ, Rodriguez-Medina C, Cuevas L, Raposo-Puglia JA, Mateos MC, Olivares M, Martinez-Chamorro C, Alonso N, Suarez S, Sanchez-Vadillo I, Sole Rodriguez M, Gonzalez BJ, Martinez-Frances A, Cuello R, Fernandez A, Martinez-Cuadron D, Labrador J; PETHEMA group; PETHEMA Group. Quizartinib for Newly Diagnosed FLT3-Internal Tandem Duplication-Negative AML: The Randomized, Double-Blind, Placebo-Controlled, Phase II QUIWI Study. J Clin Oncol. 2026 Jan;44(1):42-53. doi: 10.1200/JCO-25-01841. Epub 2025 Oct 13.

Drugs

Indications