Dissecting the heterogeneity of IGHV-mutated CLL: An eric study.

T Thomas Chatzikonstantinou (1Institute of Applied Biosciences, Center for Research and Technology, Thessaloniki, Greece) A Andreas Agathangelidis P Persefoni Talimtzi (1Institute of Applied Biosciences, Center for Research and Technology, Thessaloniki, Greece) S Stamatia Laidou (1Institute of Applied Biosciences, Center for Research and Technology, Thessaloniki, Greece) E Eva Minga (1Institute of Applied Biosciences, Center for Research and Technology, Thessaloniki, Greece) A Athanasios Roussos (1Institute of Applied Biosciences, Center for Research and Technology, Thessaloniki, Greece) M Maria Angelopoulou (2Department of Haematology, University of Athens, Laikon General Hospital, Athens, Greece) M Miguel Arguello De Tomas (3Hematology Department, Hospital de la Santa Creu i Sant Pau, IIB-Sant Pau and José Carreras Leukemia Research Institutes, Departamento de Medicina, Universidad Autónoma de Barcelona, Barcelona, Spain) D Darko Antic (4Clinic for Hematology, Clinical Center of Serbia, Faculty of Medicine, University of Belgrade, Belgrade, Serbia) F Fanny Baran-Marszak (6Département de recherche Clinique, Hôpital Avicenne, APHP, Bobigny, France) C Csaba Bödör F Francesc Bosch Albareda (5Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona, Spain) M Mark Catherwood (9Regional Molecular Diagnostics Service, Belfast Health and Social Care Trust, Belfast, Ireland) S Sophia Chatzileontiadou (10Hematology Unit, 1st Dept of Internal Medicine, AUTH, AHEPA Hospital, Thessaloniki, Greece) C Caterina Chessa (11Hematology and Stem Cell Transplantation Unit, Ospedale Oncologico A. Businco, ARNAS “G. Brotzu”, Cagliari, Italy) M Marta Coscia (15Division of Hematology, Ospedale di Circolo e Fondazione Macchi ASST Sette Laghi, University of Insubria, Varese, Italy) M Marta Crespo A Antonio Cuneo (1University of Ferrara) Z Zadie Davis (17Department of Haematology, Royal Bournemouth Hospital, Bournemouth, United Kingdom) M Maria Dimou (18Hematology, University of Athens, Laikon General Hospital, Athens, Greece) M Michael Doubek (19Department of Internal Medicine - Hematology and Oncology, University Hospital Brno and Faculty of Medicine, Masaryk University; CEITEC MU, Brno, Czech Republic, Brno, Czech Republic) M Maria Efstathopoulou (20Department of Haematology, Athens Medical Center, Psychikon Branch, Athens, Greece) B Blanca Espinet (21Molecular Cytogenetics Laboratory, Pathology Department, Hospital del Mar and Translational Research on Hematological Neoplasms Group, Hospital del Mar Research Institute (IMIM), Barcelona, Spain) G Gianluca Gaidano (13Department of Translational Medicine, University of Eastern Piedmont, Novara, Italy) R Ritu Gupta E Eleftheria Hatzimichael (24Department of Haematology, Faculty of Medicine, University of Ioannina,Greece, Ioannina, Greece) Y Yair Herishanu (13Faculty of Medicine, Tel Aviv Sourasky Medical Center, Tel Aviv University, Tel Aviv, Israel) T Thalia Karamanli (1Institute of Applied Biosciences, Center for Research and Technology, Thessaloniki, Greece) E Eliana Konstantinou (18Hematology, University of Athens, Laikon General Hospital, Athens, Greece) I Ioannis Kotsianidis (29Department of Hematology, University Hospital of Alexandroupolis, Democritus University of Thrace, Alexandroupolis, Greece) A Andreas Epameinondas Koumpis (24Department of Haematology, Faculty of Medicine, University of Ioannina,Greece, Ioannina, Greece) T Tamas Laszlo (7HCEMM-SE Molecular Oncohematology Research Group, MTA-SE Lendulet Molecular Oncohematology Research Group, Department of Pathology and Experimental Cancer Research, Semmelweis University, Budapest, Hungary) V Vincent Levy (6Département de recherche Clinique, Hôpital Avicenne, APHP, Bobigny, France) A Alexandros Machairas (18Hematology, University of Athens, Laikon General Hospital, Athens, Greece) F Francesca Martini (Dipartimento di Chimica e Chimica Industriale) R Riccardo Moia (32Division of Hematology, Department of Translational Medicine, University of Eastern Piedmont, Novara, Italy) S Samir Mouhssine (32Division of Hematology, Department of Translational Medicine, University of Eastern Piedmont, Novara, Italy) A Ana Muntanola Prat (33Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain) R Roberta Murru (11Hematology and Stem Cell Transplantation Unit, Ospedale Oncologico A. Businco, ARNAS “G. Brotzu”, Cagliari, Italy) E Eugenia Mpalaoura (1Institute of Applied Biosciences, Center for Research and Technology, Thessaloniki, Greece) G Gerassimos Pangalis (20Department of Haematology, Athens Medical Center, Psychikon Branch, Athens, Greece) M Maria Papaioannou (10Hematology Unit, 1st Dept of Internal Medicine, AUTH, AHEPA Hospital, Thessaloniki, Greece) S Sarka Pavlova K Karla Plevova (15Department of Internal Medicine - Hematology and Oncology, University Hospital Brno and Faculty of Medicine, Masaryk University; CEITEC MU, Brno, Czech Republic, Brno, Czech Republic) S Sarka Pospisilova (19Department of Internal Medicine - Hematology and Oncology, University Hospital Brno and Faculty of Medicine, Masaryk University; CEITEC MU, Brno, Czech Republic, Brno, Czech Republic) A Anna Puiggros (21Molecular Cytogenetics Laboratory, Pathology Department, Hospital del Mar and Translational Research on Hematological Neoplasms Group, Hospital del Mar Research Institute (IMIM), Barcelona, Spain) L Lata Rani (23Laboratory Oncology Unit, Dr. B.R.A. IRCH, All India Institute of Medical Sciences (AIIMS), New Delhi, India) G Gian Matteo Rigolin (16St. Anna University Hospital - Department of Medical Sciences, University of Ferrara, l, Ferrara, Italy) I Ilaria Romano (37Oncology Institute of Southern Switzerland, Bellinzona, Switzerland) D Davide Rossi (Institute of Oncology Research, Bellinzona, Switzerland) A Angel Serna (6Department of Medicine, Universitat Autònoma de Barcelona, Bellaterra, Spain; Servei d'Hematologia, Vall d'Hebron Hospital Universitari, Experimental Hematology, Vall d'Hebron Institute of Oncology (VHIO), Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain) M Martin Simkovic (254th Department of Internal Medicine-Hematology, Faculty of Medicine in Hradec Kralove, University Hospital and Charles University, Hradec Kralove, Hradec Kralove, Czech Republic) L Lukas Smolej (254th Department of Internal Medicine-Hematology, Faculty of Medicine in Hradec Kralove, University Hospital and Charles University, Hradec Kralove, Hradec Kralove, Czech Republic) N Niki Stavrogianni (41Hematology Department and HCT Unit G. Papanicolaou Hospital, Thessaloniki, Greece) K Kristina Tomic Vujovic (4Clinic for Hematology, Clinical Center of Serbia, Faculty of Medicine, University of Belgrade, Belgrade, Serbia) L Livio Trentin (Hematology Unit, Department of Medicine, University of Padua) T Theodoros Vassilakopoulos (18Hematology, University of Athens, Laikon General Hospital, Athens, Greece) A Andrea Visentin (8Hematology Unit, Department of Medicine, University of Padova, Padova, Italy) C Candida Vitale (42Division of Hematology, A.O.U. Città della Salute e della Scienza di Torino and Department of Molecular Biotechnology and Health Sciences, University of Turin, Turin, Italy) G George Vrachiolias (29Department of Hematology, University Hospital of Alexandroupolis, Democritus University of Thrace, Alexandroupolis, Greece) L Lydia Scarfò (School of Medicine, Università Vita Salute San Raffaele, Milan) A Anastasia Chatzidimitriou (1Institute of Applied Biosciences, Center for Research and Technology, Thessaloniki, Greece) P Paolo Ghia (School of Medicine, Università Vita Salute San Raffaele, Milan) K Kostas Stamatopoulos (Institute of Applied Biosciences at the Centre for Research and Technology Hellas)

Abstract

Abstract Introduction: Patients with CLL and mutated immunoglobulin heavy variable (IGHV) genes (M-CLL) are clinically heterogeneous. While genomic aberrations contribute to adverse outcomes in certain M-CLL subgroups, they do not fully account for M-CLL heterogeneity, suggesting the need for further research. Methods: This is a retrospective, observational study aiming to identify factors associated with shorter overall survival (OS) after first-line (1L) treatment in M-CLL. The study included patients diagnosed with M-CLL between 2000-2022 in 26 centers with a follow-up >6 months after 1L treatment. Special attention was given to immunogenetic features, including BcR stereotypy. Besides, we developed a novel immunogenetic metric that considers the amino acid composition of the germline IGHV genes, following the IMGT physicochemical classification table. Each aligned position across the IGHV gene sequences was assigned different scores based on the relation between the assessed amino acids: 0 if identical, 1 if in the same physicochemical group, and 2 if in different groups. This scoring system enabled the generation of a distance matrix for all IGHV genes, which was then used as input for hierarchical clustering, leading to the creation of 15 clusters. Univariable (UVA) and multivariable (MVA) analyses were performed to identify risk factors associated with shorter OS. The variables assessed in the UVA were age at 1L initiation, biological sex, type of 1L treatment, TP53 mutations, FISH aberrations, and karyotype. Results: 1933 patients from 26 centers in 12 countries were evaluated. The median age at 1L treatment was 69 years (IQR: 62-76). Most patients were males (1184, 61.3%) and 1249 (64.7%) were alive at last follow up. The median follow-up from 1L treatment was 4.6 years (IQR: 1.8-8.1). Before 1L treatment, 623/1090 (57.2%), 195/1077 (18.1%), 107/1342 (8%) and 103/1240 (8.3%) carried del(13q), trisomy 12, del(17p) and del(11q) detected by FISH, respectively. TP53 mutations were detected in 118/1012 (11.7%) cases and karyotype with ≥3 and ≥5 (CK5) aberrations in 82/610 (13.4%) and 17/610 (2.8%) cases, respectively. The most common stereotyped subsets were #2 (59/1112, 5.3%) and #4 (11/1112, 1%). Most patients (1346, 69.8%) received 1 line of treatment, while 344 (17.8%), 138 (7.2%) and 101 (5.2%) received 2, 3, and ≥4 lines, respectively. FCR was the most common 1L treatment (395, 20.8%) followed by chlorambucil (Chl) monotherapy (320, 16.9%). BTK inhibitors (BTKis) were used in 241 cases [12.5%; ibrutinib: 162 (8.3%), acalabrutinib 65 (3.4%), zanubrutinib: 10 (0.5%), pirtobrutinib 4 (0.2%)]. BR, Chl-rituximab and Chl-obinutuzumab were used in 185 (9.8%), 126 (6.6%) and 98 (5.2%) cases, respectively. Finally, 70 (3.6%) received venetoclax-obinutuzumab 1L treatment and 33 (1.7%) received ibrutinib-venetoclax. The median OS was 11 years (95% CI: 10.4-11.8). In UVA, older age at 1L, male sex, TP53 aberrations (TP53-abs), del(11q) and CK5 were associated with shorter OS (p<0.001, p=0.03, p<0.001, p<0.001, p=0.001, respectively). Compared to FCR/BR, targeted treatments led to a similar OS (p=0.3), while other non-targeted treatments resulted in shorter OS (p<0.001). Regarding the new immunogenetic metric, clusters 13 (IGHV1-24 and IGHV1-69-2 genes), 4 (IGHV2 genes) and 8 (IGHV3-13) associated with shorter OS (p=0.07, p=0.02, and p=0.002, respectively). To assess the relevance of this finding, we scanned our immunogenetic database consisting of 42,154 M-CLL IG rearrangements. While the IGHV1-24, IGHV1-69-2 and IGHV3-13 genes were very rare (0.6%), IGHV2 gene rearrangements represented a sizeable M-CLL subgroup (1969 cases, 4.7%). In MVA, only age at 1L and CK5 retained statistical significance for OS (HR: 1.08, 95% CI: 1.04-1.3, p<0.001, HR: 2.5, 95% CI: 1.04-6.2, p=0.04, respectively). In patients <70 years, older age at 1L, TP53-abs, del(11q), and clusters 4 and 8 were associated with shorter OS (p<0.001, p=0.01, p=0.007, p=0.01, and p=0.01, respectively). The type of treatment effect was similar to the whole cohort. In MVA, age at 1L andTP53-absretained statistical significance (HR:1.07, 95% CI:1.02-1.11, p=0.003, HR:1.9, 95% CI:1.02-3.5, p=0.04, respectively). Conclusion: Older age, CK5 and TP53 aberrations are independent high-risk factors for shorter OS in M-CLL. Utilization of IGHV2 subgroup genes emerged as adverse-prognostic for OS and merits further evaluation.

Article Details

Journal Blood
Volume / Issue Vol. 146, Issue Supplement 1
Published November 03, 2025
Pages 2120-2120
ISSN 0006-4971
Publisher Elsevier BV

Journal Info

Blood

Elsevier BV

ISSN: 0006-4971 Health Sciences

Authors (64)

T

Thomas Chatzikonstantinou

1Institute of Applied Biosciences, Center for Research and Technology, Thessaloniki, Greece

A

Andreas Agathangelidis

P

Persefoni Talimtzi

1Institute of Applied Biosciences, Center for Research and Technology, Thessaloniki, Greece

S

Stamatia Laidou

1Institute of Applied Biosciences, Center for Research and Technology, Thessaloniki, Greece

E

Eva Minga

1Institute of Applied Biosciences, Center for Research and Technology, Thessaloniki, Greece

A

Athanasios Roussos

1Institute of Applied Biosciences, Center for Research and Technology, Thessaloniki, Greece

M

Maria Angelopoulou

2Department of Haematology, University of Athens, Laikon General Hospital, Athens, Greece

M

Miguel Arguello De Tomas

3Hematology Department, Hospital de la Santa Creu i Sant Pau, IIB-Sant Pau and José Carreras Leukemia Research Institutes, Departamento de Medicina, Universidad Autónoma de Barcelona, Barcelona, Spain

D

Darko Antic

4Clinic for Hematology, Clinical Center of Serbia, Faculty of Medicine, University of Belgrade, Belgrade, Serbia

F

Fanny Baran-Marszak

6Département de recherche Clinique, Hôpital Avicenne, APHP, Bobigny, France

C

Csaba Bödör

F

Francesc Bosch Albareda

5Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona, Spain

M

Mark Catherwood

9Regional Molecular Diagnostics Service, Belfast Health and Social Care Trust, Belfast, Ireland

S

Sophia Chatzileontiadou

10Hematology Unit, 1st Dept of Internal Medicine, AUTH, AHEPA Hospital, Thessaloniki, Greece

C

Caterina Chessa

11Hematology and Stem Cell Transplantation Unit, Ospedale Oncologico A. Businco, ARNAS “G. Brotzu”, Cagliari, Italy

M

Marta Coscia

15Division of Hematology, Ospedale di Circolo e Fondazione Macchi ASST Sette Laghi, University of Insubria, Varese, Italy

M

Marta Crespo

A

Antonio Cuneo

1University of Ferrara

Z

Zadie Davis

17Department of Haematology, Royal Bournemouth Hospital, Bournemouth, United Kingdom

M

Maria Dimou

18Hematology, University of Athens, Laikon General Hospital, Athens, Greece

M

Michael Doubek

19Department of Internal Medicine - Hematology and Oncology, University Hospital Brno and Faculty of Medicine, Masaryk University; CEITEC MU, Brno, Czech Republic, Brno, Czech Republic

M

Maria Efstathopoulou

20Department of Haematology, Athens Medical Center, Psychikon Branch, Athens, Greece

B

Blanca Espinet

21Molecular Cytogenetics Laboratory, Pathology Department, Hospital del Mar and Translational Research on Hematological Neoplasms Group, Hospital del Mar Research Institute (IMIM), Barcelona, Spain

G

Gianluca Gaidano

13Department of Translational Medicine, University of Eastern Piedmont, Novara, Italy

R

Ritu Gupta

E

Eleftheria Hatzimichael

24Department of Haematology, Faculty of Medicine, University of Ioannina,Greece, Ioannina, Greece

Y

Yair Herishanu

13Faculty of Medicine, Tel Aviv Sourasky Medical Center, Tel Aviv University, Tel Aviv, Israel

T

Thalia Karamanli

1Institute of Applied Biosciences, Center for Research and Technology, Thessaloniki, Greece

E

Eliana Konstantinou

18Hematology, University of Athens, Laikon General Hospital, Athens, Greece

I

Ioannis Kotsianidis

29Department of Hematology, University Hospital of Alexandroupolis, Democritus University of Thrace, Alexandroupolis, Greece

A

Andreas Epameinondas Koumpis

24Department of Haematology, Faculty of Medicine, University of Ioannina,Greece, Ioannina, Greece

T

Tamas Laszlo

7HCEMM-SE Molecular Oncohematology Research Group, MTA-SE Lendulet Molecular Oncohematology Research Group, Department of Pathology and Experimental Cancer Research, Semmelweis University, Budapest, Hungary

V

Vincent Levy

6Département de recherche Clinique, Hôpital Avicenne, APHP, Bobigny, France

A

Alexandros Machairas

18Hematology, University of Athens, Laikon General Hospital, Athens, Greece

F

Francesca Martini

Dipartimento di Chimica e Chimica Industriale

R

Riccardo Moia

32Division of Hematology, Department of Translational Medicine, University of Eastern Piedmont, Novara, Italy

S

Samir Mouhssine

32Division of Hematology, Department of Translational Medicine, University of Eastern Piedmont, Novara, Italy

A

Ana Muntanola Prat

33Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain

R

Roberta Murru

11Hematology and Stem Cell Transplantation Unit, Ospedale Oncologico A. Businco, ARNAS “G. Brotzu”, Cagliari, Italy

E

Eugenia Mpalaoura

1Institute of Applied Biosciences, Center for Research and Technology, Thessaloniki, Greece

G

Gerassimos Pangalis

20Department of Haematology, Athens Medical Center, Psychikon Branch, Athens, Greece

M

Maria Papaioannou

10Hematology Unit, 1st Dept of Internal Medicine, AUTH, AHEPA Hospital, Thessaloniki, Greece

S

Sarka Pavlova

K

Karla Plevova

15Department of Internal Medicine - Hematology and Oncology, University Hospital Brno and Faculty of Medicine, Masaryk University; CEITEC MU, Brno, Czech Republic, Brno, Czech Republic

S

Sarka Pospisilova

19Department of Internal Medicine - Hematology and Oncology, University Hospital Brno and Faculty of Medicine, Masaryk University; CEITEC MU, Brno, Czech Republic, Brno, Czech Republic

A

Anna Puiggros

21Molecular Cytogenetics Laboratory, Pathology Department, Hospital del Mar and Translational Research on Hematological Neoplasms Group, Hospital del Mar Research Institute (IMIM), Barcelona, Spain

L

Lata Rani

23Laboratory Oncology Unit, Dr. B.R.A. IRCH, All India Institute of Medical Sciences (AIIMS), New Delhi, India

G

Gian Matteo Rigolin

16St. Anna University Hospital - Department of Medical Sciences, University of Ferrara, l, Ferrara, Italy

I

Ilaria Romano

37Oncology Institute of Southern Switzerland, Bellinzona, Switzerland

D

Davide Rossi

Institute of Oncology Research, Bellinzona, Switzerland

A

Angel Serna

6Department of Medicine, Universitat Autònoma de Barcelona, Bellaterra, Spain; Servei d'Hematologia, Vall d'Hebron Hospital Universitari, Experimental Hematology, Vall d'Hebron Institute of Oncology (VHIO), Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain

M

Martin Simkovic

254th Department of Internal Medicine-Hematology, Faculty of Medicine in Hradec Kralove, University Hospital and Charles University, Hradec Kralove, Hradec Kralove, Czech Republic

L

Lukas Smolej

254th Department of Internal Medicine-Hematology, Faculty of Medicine in Hradec Kralove, University Hospital and Charles University, Hradec Kralove, Hradec Kralove, Czech Republic

N

Niki Stavrogianni

41Hematology Department and HCT Unit G. Papanicolaou Hospital, Thessaloniki, Greece

K

Kristina Tomic Vujovic

4Clinic for Hematology, Clinical Center of Serbia, Faculty of Medicine, University of Belgrade, Belgrade, Serbia

L

Livio Trentin

Hematology Unit, Department of Medicine, University of Padua

T

Theodoros Vassilakopoulos

18Hematology, University of Athens, Laikon General Hospital, Athens, Greece

A

Andrea Visentin

8Hematology Unit, Department of Medicine, University of Padova, Padova, Italy

C

Candida Vitale

42Division of Hematology, A.O.U. Città della Salute e della Scienza di Torino and Department of Molecular Biotechnology and Health Sciences, University of Turin, Turin, Italy

G

George Vrachiolias

29Department of Hematology, University Hospital of Alexandroupolis, Democritus University of Thrace, Alexandroupolis, Greece

L

Lydia Scarfò

School of Medicine, Università Vita Salute San Raffaele, Milan

A

Anastasia Chatzidimitriou

1Institute of Applied Biosciences, Center for Research and Technology, Thessaloniki, Greece

P

Paolo Ghia

School of Medicine, Università Vita Salute San Raffaele, Milan

K

Kostas Stamatopoulos

Institute of Applied Biosciences at the Centre for Research and Technology Hellas