Prognostic impact of <i>FLT3</i> -ITD microclones in young adults with acute myeloid leukemia treated with intensive chemotherapy

N Nicolas Duployez (Unité Mixte de Recherche (UMR) 9020-UMR-S 1277-Canther-Cancer Heterogeneity, Plasticity and Resistance to Therapies, Institut de Recherche contre le Cancer de Lille, University of Lille, CNRS, Inserm, Centre Hospitalier Universitaire Lille, Lille, France) R Romane Joudinaud (1Laboratory of Hematology, Centre Hospitalier Universitaire de Lille, Université de Lille, INSERM U1366, Lille, France) A Augustin Boudry (1Laboratory of Hematology, Centre Hospitalier Universitaire de Lille, Université de Lille, INSERM U1366, Lille, France) M Mathilde Hunault (2Department of Hematology, Centre Hospitalier Universitaire d’Angers, INSERM, Centre National de la Recherche Scientifique, Centre de Recherche en Cancérologie et Immunologie Intégrée Nantes Angers, Fédération Hospitalo-Universitaire Grand Ouest Against Leukemia, Université d’Angers, Université de Nantes, Angers, France) L Laurene Fenwarth (Unité Mixte de Recherche (UMR) 9020-UMR-S 1277-Canther-Cancer Heterogeneity, Plasticity and Resistance to Therapies, Institut de Recherche contre le Cancer de Lille, University of Lille, CNRS, Inserm, Centre Hospitalier Universitaire Lille, Lille, France) E Emmanuelle Tavernier C Cécile Pautas (4Department of Hematology, Hôpital Henri Mondor, Assistance Publique-Hôpitaux de Paris, Créteil, France) S Sarah Bertoli S Suzanne Tavitian E Emmanuel Raffoux M Marie-Anne Hospital (7Department of Hematology, Institut Paoli-Calmettes, Marseille, France) T Tony Marchand M Maël Heiblig (9Department of Hematology, Centre Hospitalier Universitaire de Lyon, Lyon, France) S Sylvain Chantepie (10Department of Hematology, Centre Hospitalier Universitaire de Caen, Caen, France) M Martin Carré P Pierre Peterlin (12Department of Hematology, Centre Hospitalier Universitaire de Nantes, Nantes, France) M Maria-Pilar Gallego-Hernanz (13Department of Hematology, Centre Hospitalier Universitaire de Poitiers, Poitiers, France) R Romain Guieze (14Department of Hematology, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France) C Célestine Simand (15Department of Hematology, Centre Hospitalier Universitaire de Strasbourg, Strasbourg, France) P Pascal Turlure (16Department of Hematology, Centre Hospitalier Universitaire de Limoges, Limoges, France) A Anne Huynh (5Department of Hematology, Centre Hospitalier Universitaire de Toulouse, Toulouse, France) E Emilie Lemasle (17Department of Hematology, Centre Henri Becquerel, Rouen, France) L Ludovic Gabellier (18Department of Hematology, Centre Hospitalier Universitaire de Montpellier, Montpellier, France) J Juliette Lambert (19Department of Hematology, Centre Hospitalier Universitaire de Versailles, Versailles, France) F Felipe Suarez (20Department of Hematology, Hôpital Necker, Paris, France) S Samy Chraibi (21Department of Hematology, Centre Hospitalier Universitaire de Nîmes, Nîmes, France) L Laurence Sanhes (22Department of Hematology, Centre Hospitalier de Perpignan, Perpignan, France) K Karine Celli-Lebras (23Acute Leukemia French Intergroup Coordination, Paris, France) A Ariane Mineur (24Acute Leukemia French Intergroup Coordination, Bordeaux, France) C Claude Gardin (Hématologie Clinique, Hôpital Avicenne, AP-HP, Hôpitaux Universitaires Paris Seine Saint-Denis, Bobigny, France) N Norbert Ifrah (2Department of Hematology, Centre Hospitalier Universitaire d’Angers, INSERM, Centre National de la Recherche Scientifique, Centre de Recherche en Cancérologie et Immunologie Intégrée Nantes Angers, Fédération Hospitalo-Universitaire Grand Ouest Against Leukemia, Université d’Angers, Université de Nantes, Angers, France) N Norbert Vey (7Department of Hematology, Institut Paoli-Calmettes, Marseille, France) R Régis Peffault de Latour L Lucie Rigolot (26Laboratory of Hematology, Centre Hospitalier Universitaire de Toulouse, Toulouse, France) I Isabelle Luquet (26Laboratory of Hematology, Centre Hospitalier Universitaire de Toulouse, Toulouse, France) D Dominique Penther (27Laboratory of Genetics, Centre Henri Becquerel, Rouen, France) R Raphaël Itzykson (6Department of Hematology, Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Université Paris Cité, Paris, France) Éric Delabesse (26Laboratory of Hematology, Centre Hospitalier Universitaire de Toulouse, Toulouse, France) J Jean-François Hamel (28Department of Biostatistics, Centre Hospitalier Universitaire d’Angers, Angers, France) S Stéphane de Botton A Arnaud Pigneux H Hervé Dombret C Christian Récher C Claude Preudhomme (Unité Mixte de Recherche (UMR) 9020-UMR-S 1277-Canther-Cancer Heterogeneity, Plasticity and Resistance to Therapies, Institut de Recherche contre le Cancer de Lille, University of Lille, CNRS, Inserm, Centre Hospitalier Universitaire Lille, Lille, France) P Pierre-Yves Dumas

Abstract

Abstract FLT3 internal tandem duplications (FLT3-ITD) are major genetic events in acute myeloid leukemia (AML). Although the clinical impact of FLT3-ITD “macroclones” (allelic ratio [AR] ≥0.05) is well established, the significance of low-level FLT3-ITD subclones (“microclones”) remains uncertain. We conducted a post hoc analysis of 1733 patients with newly diagnosed AML enrolled in the Backbone Intergroup 1 trial (ClinicalTrials.gov identifier: NCT02416388). Using next-generation sequencing (NGS), we detected FLT3-ITD microclones (AR between 0.0004 and 0.05) in 17.4% of patients without FLT3-ITD macroclones. Microclones and macroclones (low and high AR) were independently associated with increased relapse risk (cause-specific hazard ratio, 1.50 [95% confidence interval (CI), 1.18-1.91]; 1.98 [1.50-2.62]; and 2.33 [1.69-3.22], respectively) after adjustment for age, white blood cell count, other gene mutations, midostaurin treatment, and allogeneic hematopoietic stem cell transplantation. At 2 years, the cumulative incidence of relapse reached 42.5% (95% CI, 37.0-47.9) in patients with macroclones, 45.1% (38.3-51.6) in patients with microclones, and 29.4% (26.6-32.3) in patients without FLT3-ITD. In NPM1-mutated AML, both microclones and macroclones were associated with higher levels of measurable residual disease (MRD) and increased relapse risk, without independent impact on overall survival after adjustment for MRD. An analysis of paired samples further revealed that 41.8% of relapses in patients with FLT3-ITD microclones at diagnosis were associated with a macroclone at relapse. These findings challenge current risk stratification models and support the integration of NGS-based FLT3-ITD detection into the diagnostic and prognostic workflow for AML. Prospective trials addressing the management of patients with FLT3-ITD microclones are warranted, as is their consideration in future European LeukemiaNet guidelines.

Article Details

Journal Blood
Volume / Issue Vol. 148, Issue 5
Published July 30, 2026
Pages 598-609
ISSN 0006-4971
Publisher Elsevier BV

Journal Info

Blood

Elsevier BV

ISSN: 0006-4971 Health Sciences

Authors (45)

N

Nicolas Duployez

Unité Mixte de Recherche (UMR) 9020-UMR-S 1277-Canther-Cancer Heterogeneity, Plasticity and Resistance to Therapies, Institut de Recherche contre le Cancer de Lille, University of Lille, CNRS, Inserm, Centre Hospitalier Universitaire Lille, Lille, France

R

Romane Joudinaud

1Laboratory of Hematology, Centre Hospitalier Universitaire de Lille, Université de Lille, INSERM U1366, Lille, France

A

Augustin Boudry

1Laboratory of Hematology, Centre Hospitalier Universitaire de Lille, Université de Lille, INSERM U1366, Lille, France

M

Mathilde Hunault

2Department of Hematology, Centre Hospitalier Universitaire d’Angers, INSERM, Centre National de la Recherche Scientifique, Centre de Recherche en Cancérologie et Immunologie Intégrée Nantes Angers, Fédération Hospitalo-Universitaire Grand Ouest Against Leukemia, Université d’Angers, Université de Nantes, Angers, France

L

Laurene Fenwarth

Unité Mixte de Recherche (UMR) 9020-UMR-S 1277-Canther-Cancer Heterogeneity, Plasticity and Resistance to Therapies, Institut de Recherche contre le Cancer de Lille, University of Lille, CNRS, Inserm, Centre Hospitalier Universitaire Lille, Lille, France

E

Emmanuelle Tavernier

C

Cécile Pautas

4Department of Hematology, Hôpital Henri Mondor, Assistance Publique-Hôpitaux de Paris, Créteil, France

S

Sarah Bertoli

S

Suzanne Tavitian

E

Emmanuel Raffoux

M

Marie-Anne Hospital

7Department of Hematology, Institut Paoli-Calmettes, Marseille, France

T

Tony Marchand

M

Maël Heiblig

9Department of Hematology, Centre Hospitalier Universitaire de Lyon, Lyon, France

S

Sylvain Chantepie

10Department of Hematology, Centre Hospitalier Universitaire de Caen, Caen, France

M

Martin Carré

P

Pierre Peterlin

12Department of Hematology, Centre Hospitalier Universitaire de Nantes, Nantes, France

M

Maria-Pilar Gallego-Hernanz

13Department of Hematology, Centre Hospitalier Universitaire de Poitiers, Poitiers, France

R

Romain Guieze

14Department of Hematology, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France

C

Célestine Simand

15Department of Hematology, Centre Hospitalier Universitaire de Strasbourg, Strasbourg, France

P

Pascal Turlure

16Department of Hematology, Centre Hospitalier Universitaire de Limoges, Limoges, France

A

Anne Huynh

5Department of Hematology, Centre Hospitalier Universitaire de Toulouse, Toulouse, France

E

Emilie Lemasle

17Department of Hematology, Centre Henri Becquerel, Rouen, France

L

Ludovic Gabellier

18Department of Hematology, Centre Hospitalier Universitaire de Montpellier, Montpellier, France

J

Juliette Lambert

19Department of Hematology, Centre Hospitalier Universitaire de Versailles, Versailles, France

F

Felipe Suarez

20Department of Hematology, Hôpital Necker, Paris, France

S

Samy Chraibi

21Department of Hematology, Centre Hospitalier Universitaire de Nîmes, Nîmes, France

L

Laurence Sanhes

22Department of Hematology, Centre Hospitalier de Perpignan, Perpignan, France

K

Karine Celli-Lebras

23Acute Leukemia French Intergroup Coordination, Paris, France

A

Ariane Mineur

24Acute Leukemia French Intergroup Coordination, Bordeaux, France

C

Claude Gardin

Hématologie Clinique, Hôpital Avicenne, AP-HP, Hôpitaux Universitaires Paris Seine Saint-Denis, Bobigny, France

N

Norbert Ifrah

2Department of Hematology, Centre Hospitalier Universitaire d’Angers, INSERM, Centre National de la Recherche Scientifique, Centre de Recherche en Cancérologie et Immunologie Intégrée Nantes Angers, Fédération Hospitalo-Universitaire Grand Ouest Against Leukemia, Université d’Angers, Université de Nantes, Angers, France

N

Norbert Vey

7Department of Hematology, Institut Paoli-Calmettes, Marseille, France

R

Régis Peffault de Latour

L

Lucie Rigolot

26Laboratory of Hematology, Centre Hospitalier Universitaire de Toulouse, Toulouse, France

I

Isabelle Luquet

26Laboratory of Hematology, Centre Hospitalier Universitaire de Toulouse, Toulouse, France

D

Dominique Penther

27Laboratory of Genetics, Centre Henri Becquerel, Rouen, France

R

Raphaël Itzykson

6Department of Hematology, Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Université Paris Cité, Paris, France

Éric Delabesse

26Laboratory of Hematology, Centre Hospitalier Universitaire de Toulouse, Toulouse, France

J

Jean-François Hamel

28Department of Biostatistics, Centre Hospitalier Universitaire d’Angers, Angers, France

S

Stéphane de Botton

A

Arnaud Pigneux

H

Hervé Dombret

C

Christian Récher

C

Claude Preudhomme

Unité Mixte de Recherche (UMR) 9020-UMR-S 1277-Canther-Cancer Heterogeneity, Plasticity and Resistance to Therapies, Institut de Recherche contre le Cancer de Lille, University of Lille, CNRS, Inserm, Centre Hospitalier Universitaire Lille, Lille, France

P

Pierre-Yves Dumas