Clinical significance of preleukemic somatic <i>GATA1</i> mutations in children with Down syndrome

N Natalina Elliott (University of Oxford, Headington, United Kingdom) N Neha Bhatnagar (1Department of Paediatrics, MRC Weatherall Institute of Molecular Medicine, University of Oxford, Oxford, United Kingdom) G Gemma Buck (1Department of Paediatrics, MRC Weatherall Institute of Molecular Medicine, University of Oxford, Oxford, United Kingdom) D David Cruz Hernandez (2MRC Molecular Haematology Unit, MRC Weatherall Institute of Molecular Medicine, University of Oxford, Oxford, United Kingdom) K Kelly Perkins (2MRC Molecular Haematology Unit, MRC Weatherall Institute of Molecular Medicine, University of Oxford, Oxford, United Kingdom) A Adam J. de Smith (5Center for Genetic Epidemiology, Keck School of Medicine of University of Southern California, Los Angeles, CA) A Amelie Chaussade (1Department of Paediatrics, MRC Weatherall Institute of Molecular Medicine, University of Oxford, Oxford, United Kingdom) L Laure Nizery (1Department of Paediatrics, MRC Weatherall Institute of Molecular Medicine, University of Oxford, Oxford, United Kingdom) M Marlen Metzner (1Medical Research Council Molecular Haematology Unit, Radcliffe Department of Medicine, Weatherall Institute of Medicine, University of Oxford, Oxford, United Kingdom) C Catherine Garnett (2MRC Molecular Haematology Unit, MRC Weatherall Institute of Molecular Medicine, University of Oxford, Oxford, United Kingdom) A Alice Norton (6Department of Haematology, Birmingham Women’s and Children’s NHS Foundation Trust, Birmingham, United Kingdom) A Alison Kennedy (2MRC Molecular Haematology Unit, MRC Weatherall Institute of Molecular Medicine, University of Oxford, Oxford, United Kingdom) T Triya Chakravorty (1Department of Paediatrics, MRC Weatherall Institute of Molecular Medicine, University of Oxford, Oxford, United Kingdom) D Dylan Zhao (7Oxford Medical Schools Division, University of Oxford, Oxford, United Kingdom) L Lars Hanssen (2MRC Molecular Haematology Unit, MRC Weatherall Institute of Molecular Medicine, University of Oxford, Oxford, United Kingdom) G Georgina Hall (1Department of Paediatrics, MRC Weatherall Institute of Molecular Medicine, University of Oxford, Oxford, United Kingdom) P Paresh Vyas I Irene Roberts

Abstract

Abstract Children with Down syndrome (DS) have a high risk of GATA1-associated myeloid leukemia (ML-DS) before age 4 years. Somatic N-terminal GATA1 mutations (GATA1s) are necessary, but not sufficient, for ML-DS, but their significance at birth for individual babies and whether mutations occur after birth is unclear. To address these questions, we performed a prospective study of newborns with DS using next-generation sequencing-based GATA1 mutation analysis, with hematologic and clinical evaluation and follow-up for the window of ML-DS risk. Of 450 neonates with DS, 113 (25%) had GATA1s mutations, among whom 20/113 (17.7%) had multiple mutations and 59 (52%) were clinically silent. Variant allele frequency (VAF) varied from 0.3% to 89%. VAF positively correlated (P &amp;lt; .0001) with the percent blasts, leukocytes, dyserythropoiesis and dysmegakaryopoiesis scores, and clinical disease severity, and negatively with hemoglobin, although only 4/113 were anemic. GATA1s mutations were detected from 28 weeks gestation; the highest frequency (45%) was at 34 to 35 weeks, whereas mutation frequency in early fetal samples (&amp;lt;20 weeks) was &amp;lt;4% (2/57). GATA1s clones (VAF, percent blasts) fell rapidly postnatally, becoming undetectable by 6 months, except in neonates who developed ML-DS. Of 110 surviving neonates, 7 (6.4%) developed ML-DS at a median age of 17.5 months. GATA1s clone size at birth was the only predictor of ML-DS. No neonates lacking GATA1s mutations acquired mutations after birth or developed ML-DS. Taken together, the fetal environment is essential for GATA1s mutation selection and expansion of GATA1s clones. Rates of leukemic transformation of GATA1s clones detected at birth are low, but clones that persist &amp;gt;6 months transformed.

Article Details

Journal Blood
Volume / Issue Vol. 146, Issue 13
Published September 25, 2025
Pages 1561-1574
ISSN 0006-4971
Publisher Elsevier BV

Journal Info

Blood

Elsevier BV

ISSN: 0006-4971 Health Sciences

Authors (18)

N

Natalina Elliott

University of Oxford, Headington, United Kingdom

N

Neha Bhatnagar

1Department of Paediatrics, MRC Weatherall Institute of Molecular Medicine, University of Oxford, Oxford, United Kingdom

G

Gemma Buck

1Department of Paediatrics, MRC Weatherall Institute of Molecular Medicine, University of Oxford, Oxford, United Kingdom

D

David Cruz Hernandez

2MRC Molecular Haematology Unit, MRC Weatherall Institute of Molecular Medicine, University of Oxford, Oxford, United Kingdom

K

Kelly Perkins

2MRC Molecular Haematology Unit, MRC Weatherall Institute of Molecular Medicine, University of Oxford, Oxford, United Kingdom

A

Adam J. de Smith

5Center for Genetic Epidemiology, Keck School of Medicine of University of Southern California, Los Angeles, CA

A

Amelie Chaussade

1Department of Paediatrics, MRC Weatherall Institute of Molecular Medicine, University of Oxford, Oxford, United Kingdom

L

Laure Nizery

1Department of Paediatrics, MRC Weatherall Institute of Molecular Medicine, University of Oxford, Oxford, United Kingdom

M

Marlen Metzner

1Medical Research Council Molecular Haematology Unit, Radcliffe Department of Medicine, Weatherall Institute of Medicine, University of Oxford, Oxford, United Kingdom

C

Catherine Garnett

2MRC Molecular Haematology Unit, MRC Weatherall Institute of Molecular Medicine, University of Oxford, Oxford, United Kingdom

A

Alice Norton

6Department of Haematology, Birmingham Women’s and Children’s NHS Foundation Trust, Birmingham, United Kingdom

A

Alison Kennedy

2MRC Molecular Haematology Unit, MRC Weatherall Institute of Molecular Medicine, University of Oxford, Oxford, United Kingdom

T

Triya Chakravorty

1Department of Paediatrics, MRC Weatherall Institute of Molecular Medicine, University of Oxford, Oxford, United Kingdom

D

Dylan Zhao

7Oxford Medical Schools Division, University of Oxford, Oxford, United Kingdom

L

Lars Hanssen

2MRC Molecular Haematology Unit, MRC Weatherall Institute of Molecular Medicine, University of Oxford, Oxford, United Kingdom

G

Georgina Hall

1Department of Paediatrics, MRC Weatherall Institute of Molecular Medicine, University of Oxford, Oxford, United Kingdom

P

Paresh Vyas

I

Irene Roberts