Measurable Residual Disease-Dependent Unfavorable Outcomes in Pediatric PAX5-Rearranged B-Acute Lymphoblastic Leukemia

N Nicolò Peccatori (Tettamanti Center, Fondazione IRCCS San Gerardo Dei Tintori, Monza, Italy) A Alessia Curto (Tettamanti Center, Fondazione IRCCS San Gerardo Dei Tintori, Monza, Italy) D Daniela Silvestri (Clinica Pediatrica - Ospedale San Gerardo, Monza, Italy) S Stefano Rebellato (Tettamanti Center, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy) Željko Antić (University Hospital Würzburg, Würzburg, Germany) K Karin Nebral A Anke Katharina Bergmann (University Hospital Würzburg, Würzburg, Germany) S Sabine Strehl (St. Anna Children's Cancer Research Institute (CCRI), Vienna, Austria) M Martin Zimmermann (Hannover Medical School, Hannover, Germany) C Claudia Saitta (Tettamanti Center, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy) C Chiara Palmi (Tettamanti Center, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy) M Michela Bardini (Tettamanti Center, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy) S Sanil Bhatia A Arndt Borkhardt (Heinrich-Heine-University, Dusseldorf, Germany) M Manuel Quadri (Tettamanti Center, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy) D Daniela Guardo (IRCCS Istituto Giannina Gaslini, Genoa, Italy) L Luca Lo Nigro (Center of Pediatric Hematology Oncology) R Rosanna Parasole (AORN Santobono-Pausilipon IRCCS, Naples, Italy) M Maria Caterina Putti (Università di Padova, Padova, Italy) F Franco Locatelli (IRCCS Ospedale Pediatrico Bambino Gesù Rome, Rome) J Julia Alten (Dept. of Pediatrics, UKSH, Kiel, Germany) M Martin Stanulla (Hannover Medical School, Hannover, Germany) B Barbara Buldini J Jolanda Sarno K Kara L. Davis V Valentino Conter (Tettamanti Center, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy) A Adriana Cristina Balduzzi M Maria Grazia Valsecchi A Andrea Biondi A Andishe Attarbaschi M Martin Schrappe G Gunnar Cario (University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany) C Carmelo Rizzari (IRCCS San Gerardo dei Tintori, Monza and University of Milano-Bicocca,University of Milano-Bicocca, Monza, Italy) G Giovanni Cazzaniga (University of Milano-Bicocca, Monza, Italy) G Grazia Fazio (Tettamanti Center, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy)

Abstract

PAX5-altered acute lymphoblastic leukemia (PAX5-alt ALL) is a recently recognized molecular subtype of B-ALL characterized by a distinct transcriptional signature and frequent PAX5 fusions (PAX5-r). While PAX5-alt ALL has been associated with intermediate outcomes, clinical data specifically investigating pediatric PAX5-r ALL remain limited. We collected and analyzed 159 pediatric cases of PAX5-r ALL treated between 2001-2024 within AIEOP-BFM ALL studies across Italy, Germany and Austria, revealing high-risk clinical features. Comparative analyses of patients consecutively enrolled in the AIEOP-BFM ALL 2017 study (PAX5-r, n=96 vs. non-PAX5-r, n=1948) confirmed higher rates of hyperleukocytosis at diagnosis (22.9% vs. 8%, p<0.001) and enrichment of IKZF1plus profile (14.7% vs. 7.8%, p=0.0015) in PAX5-r patients. No relevant differences in terms of minimal/measurable residual disease (MRD)-based treatment response and risk-group stratification were observed. PAX5-r patients had a 4-year EFS and OS of 72.6±5.7% and 95.4±2.3%, respectively. Four-year EFS were 100%, 63.4±9.7% and 63.3±10% for standard-risk, medium-risk (MR) and high-risk (HR) groups, respectively, indicating that the poor prognostic impact of PAX5-r applies only when end-of-induction MRD is positive (MR/HR). Whole transcriptome sequencing revealed high FLT3 median expression in PAX5-r ALL and high-throughput drug screening of patient-derived xenografts (PDXs) showed marked sensitivity to several FLT3 inhibitors. Gilteritinib showed potent ex vivo cytotoxicity and synergism with dexamethasone in PAX5-r PDX models. Collectively, this study investigated clinical and biological features of pediatric PAX5-r ALL highlighting its MRD-dependent unfavorable prognosis and identifying FLT3 overexpression as a novel, potential therapeutic target.

Article Details

Journal Blood
Volume / Issue Vol. 1, Issue 1
Published August 10, 2026
ISSN 0006-4971
Publisher Elsevier BV

Journal Info

Blood

Elsevier BV

ISSN: 0006-4971 Health Sciences

Authors (35)

N

Nicolò Peccatori

Tettamanti Center, Fondazione IRCCS San Gerardo Dei Tintori, Monza, Italy

A

Alessia Curto

Tettamanti Center, Fondazione IRCCS San Gerardo Dei Tintori, Monza, Italy

D

Daniela Silvestri

Clinica Pediatrica - Ospedale San Gerardo, Monza, Italy

S

Stefano Rebellato

Tettamanti Center, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy

Željko Antić

University Hospital Würzburg, Würzburg, Germany

K

Karin Nebral

A

Anke Katharina Bergmann

University Hospital Würzburg, Würzburg, Germany

S

Sabine Strehl

St. Anna Children's Cancer Research Institute (CCRI), Vienna, Austria

M

Martin Zimmermann

Hannover Medical School, Hannover, Germany

C

Claudia Saitta

Tettamanti Center, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy

C

Chiara Palmi

Tettamanti Center, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy

M

Michela Bardini

Tettamanti Center, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy

S

Sanil Bhatia

A

Arndt Borkhardt

Heinrich-Heine-University, Dusseldorf, Germany

M

Manuel Quadri

Tettamanti Center, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy

D

Daniela Guardo

IRCCS Istituto Giannina Gaslini, Genoa, Italy

L

Luca Lo Nigro

Center of Pediatric Hematology Oncology

R

Rosanna Parasole

AORN Santobono-Pausilipon IRCCS, Naples, Italy

M

Maria Caterina Putti

Università di Padova, Padova, Italy

F

Franco Locatelli

IRCCS Ospedale Pediatrico Bambino Gesù Rome, Rome

J

Julia Alten

Dept. of Pediatrics, UKSH, Kiel, Germany

M

Martin Stanulla

Hannover Medical School, Hannover, Germany

B

Barbara Buldini

J

Jolanda Sarno

K

Kara L. Davis

V

Valentino Conter

Tettamanti Center, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy

A

Adriana Cristina Balduzzi

M

Maria Grazia Valsecchi

A

Andrea Biondi

A

Andishe Attarbaschi

M

Martin Schrappe

G

Gunnar Cario

University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany

C

Carmelo Rizzari

IRCCS San Gerardo dei Tintori, Monza and University of Milano-Bicocca,University of Milano-Bicocca, Monza, Italy

G

Giovanni Cazzaniga

University of Milano-Bicocca, Monza, Italy

G

Grazia Fazio

Tettamanti Center, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy