QuANTUM-First

Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.

Official title

A Phase 3, Double-Blind, Placebo-controlled Study of Quizartinib Administered in Combination With Induction and Consolidation Chemotherapy, and Administered as Continuation Therapy in Subjects 18 to 75 Years Old With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (QuANTUM First)

Phase

Phase 3

Status

Completed

Conditions

Acute Myeloid Leukemia; Leukemia

Interventions

Chemotherapy; Quizartinib; Placebo

Arms

• Chemotherapy plus quizartinib · Experimental
• Chemotherapy plus placebo · Active comparator

Enrollment

539

Primary outcomes

• Overall Survival in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia

Sponsor

Daiichi Sankyo

Start

Sep 1, 2016

Primary completion

Aug 13, 2021

Results posted

Yes

Registry record

NCT02668653 · updated Aug 6, 2024

• 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. PubMed 41949390
• 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. PubMed 41791832
• 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. PubMed 41052406
• 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. PubMed 40079105
• 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. PubMed 37116523
• 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. PubMed 29859851