Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML)

Summary

Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research. Adults might be able to join this study after bone marrow tests show they have a certain kind of blood cancer (FLT3-ITD AML). Participants will have an equal chance of receiving quizartinib or placebo along with their chemotherapy.

Timeline

Start

2016-09-01

Primary completion

2021-08-13

Completion

2023-06-16

Publications

• Levis MJ, Erba HP, Montesinos P, Patkowska E, Cortes J, Perl AE, Dombret H, Amadori S, Wang J, Schlenk RF, Liu L, Mostafa Kamel Y, Imadalou K, Laadem A, Burns K, Sekeres MA. Quizartinib for patients with newly diagnosed FLT3-ITD-positive AML who received maintenance therapy in QuANTUM-First. Blood Adv. 2026 Jun 23;10(12):4144-4159. doi: 10.1182/bloodadvances.2025017738.
• Oliva EN, Cottone F, Unni S, Correges A, Hansen JB, Marston XL, Cortes J, Sekeres MA. Patient-reported outcomes in newly diagnosed patients with FLT3-internal-tandem-duplication-positive acute myeloid leukaemia receiving standard chemotherapy plus quizartinib or placebo (QuANTUM-First): a global, randomised, placebo-controlled, phase 3 trial. Lancet Haematol. 2026 Mar;13(3):e169-e180. doi: 10.1016/S2352-3026(25)00361-8.
• Levis MJ, Erba HP, Montesinos P, Kim HJ, Vrhovac R, Patkowska E, Zak P, Wang PN, Connolly Rohrbach JE, Chang KCN, Liu L, Mostafa Kamel Y, Imadalou K, Lesegretain A, Cortes J, Sekeres MA, Dombret H, Amadori S, Wang J, Schlenk RF, Perl AE. FLT3-ITD measurable residual disease from the QuANTUM-First trial. Blood Adv. 2026 Feb 10;10(3):917-928. doi: 10.1182/bloodadvances.2025016444.
• Schlenk RF, Montesinos P, Kim HJ, Romero-Aguilar A, Vrhovac R, Patkowska E, Zak P, Wang PN, Hanyok J, Liu L, Kamel YM, Imadalou K, Lesegretain A, Cortes J, Sekeres MA, Dombret H, Amadori S, Wang J, Perl AE, Levis MJ, Erba HP. Impact of hematopoietic cell transplantation and quizartinib in newly diagnosed patients with acute myeloid leukemia and FMS-like tyrosine kinase 3-internal tandem duplications in the QuANTUM-First trial. Haematologica. 2025 Sep 1;110(9):2024-2039. doi: 10.3324/haematol.2024.286623. Epub 2025 Mar 13.
• Erba HP, Montesinos P, Kim HJ, Patkowska E, Vrhovac R, Zak P, Wang PN, Mitov T, Hanyok J, Kamel YM, Rohrbach JEC, Liu L, Benzohra A, Lesegretain A, Cortes J, Perl AE, Sekeres MA, Dombret H, Amadori S, Wang J, Levis MJ, Schlenk RF; QuANTUM-First Study Group. Quizartinib plus chemotherapy in newly diagnosed patients with FLT3-internal-tandem-duplication-positive acute myeloid leukaemia (QuANTUM-First): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023 May 13;401(10388):1571-1583. doi: 10.1016/S0140-6736(23)00464-6. Epub 2023 Apr 25.
• Cortes J, Perl AE, Dohner H, Kantarjian H, Martinelli G, Kovacsovics T, Rousselot P, Steffen B, Dombret H, Estey E, Strickland S, Altman JK, Baldus CD, Burnett A, Kramer A, Russell N, Shah NP, Smith CC, Wang ES, Ifrah N, Gammon G, Trone D, Lazzaretto D, Levis M. Quizartinib, an FLT3 inhibitor, as monotherapy in patients with relapsed or refractory acute myeloid leukaemia: an open-label, multicentre, single-arm, phase 2 trial. Lancet Oncol. 2018 Jul;19(7):889-903. doi: 10.1016/S1470-2045(18)30240-7. Epub 2018 May 31.

Drugs

Indications