Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML

Phase 3 Active not recruiting 700 enrolled Daiichi Sankyo

RandomizedParallel-groupTriple-blindTreatment

Summary

This study will compare the effects of Quizartinib versus placebo in combination with chemotherapy in participants with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML).

Timeline

Start: 2024-11-19
Primary completion: 2030-06-26
Completion: 2030-06-26

Publications

Montesinos P, Altman JK, Bullinger L, Cheong JW, Fathi AT, Levis MJ, Luger S, Miyamoto T, Oliva EN, Perl AE, Recher C, Veiga RR, Wang J, Zeidan AM, Liu L, Duong Y, Rohrbach JEC, Inghirami G, Alexis K, Gosberg A, Nahar A, Burns K, Daver N, Erba HP. QuANTUM-Wild: a Phase III, randomized trial of quizartinib in newly diagnosed FLT3-ITD-negative acute myeloid leukemia. Future Oncol. 2026 Jul 11:1-12. doi: 10.1080/14796694.2026.2689464. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Quizartinib	Small molecule	60 mg	Oral
Background	Cytarabine	Small molecule	—	—
Background	Daunorubicin	Small molecule	—	—
Background	Idarubicin	Small molecule	—	—

Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML

Summary

Timeline

Publications

Drugs

Indications