The landscape and evolution of clonal hematopoiesis in chronic lymphocytic leukemia

O Othman Al-Sawaf B Benjamin N. Locher (3Department of Hematology, Oncology, and Cancer Immunology, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany) F Friederike Christen (1Department of Hematology, Oncology, and Cancer Immunology, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin Institute of Health, Berlin, Germany) R Raphael Hablesreiter (1Department of Hematology, Oncology, and Cancer Immunology, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin Institute of Health, Berlin, Germany) A Anantharamanan Rajamani (1Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Faculty of Medicine and University Hospital of Cologne, Cologne, Germany) S Sandra Robrecht (Department I of Internal Medicine, Center of Integrated Oncology Aachen Bonn Cologne Düsseldorf, University Hospital of Cologne, Cologne, Germany) C Can Zhang (School of Integrated Circuits and Electronics, MIIT Key Laboratory for Low-Dimensional Quantum Structure and Devices) A Anna Maria Fink (Department I of Internal Medicine, Center of Integrated Oncology Aachen Bonn Cologne Düsseldorf, University Hospital of Cologne, Cologne, Germany) E Eugen Tausch (Division of CLL, Department of Internal Medicine III, Ulm University, Ulm, Germany) C Christof Schneider (Division of CLL, Department of Internal Medicine III, Ulm University, Ulm, Germany) M Matthias Ritgen (Universitaetsklinikum Schleswig-Holstein, Medizinische Klinik II, Kiel, Germany) K Karl-Anton Kreuzer (Department I of Internal Medicine, Center of Integrated Oncology Aachen Bonn Cologne Düsseldorf, University Hospital of Cologne, Cologne, Germany) K Klara Kopp (1Department of Hematology, Oncology, and Cancer Immunology, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin Institute of Health, Berlin, Germany) M Marie-Elisa Mertz (3Department of Hematology, Oncology, and Cancer Immunology, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany) C Coral Fustero-Torre (3Department of Hematology, Oncology, and Cancer Immunology, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany) K Karsten Kleo (6Department of Pathology, Charité-Universitätsmedizin Berlin, Freie Universität Berlin Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany) J John Seymour (7Peter MacCallum Cancer Center, Melbourne, Australia) P Piers Blombery (Peter MacCallum Cancer Centre, Melbourne, VIC, Australia) L Lars Bullinger B Brenda Chyla (Abbvie, North Chicago, Illinois, United States) H Hyun Yong Jin (12Genentech, Inc, South San Francisco, CA) Y Yanwen Jiang (12Genentech, Inc, South San Francisco, CA) S Stephan Stilgenbauer (Division of CLL, Department of Internal Medicine III, Ulm University, Ulm, Germany) M Michael Hallek (Department I of Internal Medicine, Center of Integrated Oncology Aachen Bonn Cologne Düsseldorf, University Hospital of Cologne, Cologne, Germany) B Barbara Eichhorst (Department I of Internal Medicine, Center of Integrated Oncology Aachen Bonn Cologne Düsseldorf, University Hospital of Cologne, Cologne, Germany) P Petra Langerbeins (University Hospital, Cologne, Germany) K Kirsten Fischer (Department I of Internal Medicine, Center of Integrated Oncology Aachen Bonn Cologne Düsseldorf, University Hospital of Cologne, Cologne, Germany) F Frederik Damm (Charité–Universitätsmedizin Berlin, Berlin)

Abstract

Abstract Chronic lymphocytic leukemia (CLL) and clonal hematopoiesis (CH) both commonly occur in older individuals. To characterize CH in CLL, 620 patients were analyzed (CLL12 [ibrutinib vs placebo] and CLL14 [venetoclax-obinutuzumab (Ven-Obi) vs chlorambucil-obinutuzumab (Clb-Obi)]) using error-corrected next-generation sequencing with a variant allele frequency (VAF) threshold of 0.5%. Median follow-up was 76.1 months, and median age was 68 years. CH was detected in 58.2% of patients, most commonly affecting DNMT3A, TET2, TP53, and ASXL1. Longitudinal analysis in CLL14 revealed persistence of the majority of CH clones during follow-up, whereas in more than half of the patients, additional CH mutations were detected. BAX- and U2AF1-mutated CH emerged during Ven-Obi exposure, and PPM1D-mutated CH emerged during Clb-Obi exposure, highlighting treatment gene–specific selection. Clonal fitness analyses revealed accelerated CH clone expansion during therapy, followed by slower growth after treatment. In vitro, genetically modified CD34+ hematopoietic stem/progenitor cells harboring BAX mutations showed enhanced survival and decreased apoptosis. CH was associated with neutropenia, and all patients with Richter transformation (RT; n = 11) had CH. Whole-exome sequencing delineated the contribution of CH mutations in 2 of 4 investigated patients with RT. Large CH clone size (>10% VAF) was independently associated with shorter overall survival with placebo (P = .049) and shorter progression-free survival with Clb-Obi after adjusting for age, immunoglobulin heavy chain variable status, and del(17p). In contrast, CH had no prognostic impact in patients receiving targeted therapies. This study demonstrates the high prevalence of CH, highlights its differential impact across CLL therapies, and underscores its adverse influence on patient outcomes.

Article Details

Journal Blood
Volume / Issue Vol. 147, Issue 12
Published March 19, 2026
Pages 1323-1337
ISSN 0006-4971
Publisher Elsevier BV

Journal Info

Blood

Elsevier BV

ISSN: 0006-4971 Health Sciences

Authors (28)

O

Othman Al-Sawaf

B

Benjamin N. Locher

3Department of Hematology, Oncology, and Cancer Immunology, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany

F

Friederike Christen

1Department of Hematology, Oncology, and Cancer Immunology, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin Institute of Health, Berlin, Germany

R

Raphael Hablesreiter

1Department of Hematology, Oncology, and Cancer Immunology, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin Institute of Health, Berlin, Germany

A

Anantharamanan Rajamani

1Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Faculty of Medicine and University Hospital of Cologne, Cologne, Germany

S

Sandra Robrecht

Department I of Internal Medicine, Center of Integrated Oncology Aachen Bonn Cologne Düsseldorf, University Hospital of Cologne, Cologne, Germany

C

Can Zhang

School of Integrated Circuits and Electronics, MIIT Key Laboratory for Low-Dimensional Quantum Structure and Devices

A

Anna Maria Fink

Department I of Internal Medicine, Center of Integrated Oncology Aachen Bonn Cologne Düsseldorf, University Hospital of Cologne, Cologne, Germany

E

Eugen Tausch

Division of CLL, Department of Internal Medicine III, Ulm University, Ulm, Germany

C

Christof Schneider

Division of CLL, Department of Internal Medicine III, Ulm University, Ulm, Germany

M

Matthias Ritgen

Universitaetsklinikum Schleswig-Holstein, Medizinische Klinik II, Kiel, Germany

K

Karl-Anton Kreuzer

Department I of Internal Medicine, Center of Integrated Oncology Aachen Bonn Cologne Düsseldorf, University Hospital of Cologne, Cologne, Germany

K

Klara Kopp

1Department of Hematology, Oncology, and Cancer Immunology, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin Institute of Health, Berlin, Germany

M

Marie-Elisa Mertz

3Department of Hematology, Oncology, and Cancer Immunology, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany

C

Coral Fustero-Torre

3Department of Hematology, Oncology, and Cancer Immunology, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany

K

Karsten Kleo

6Department of Pathology, Charité-Universitätsmedizin Berlin, Freie Universität Berlin Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany

J

John Seymour

7Peter MacCallum Cancer Center, Melbourne, Australia

P

Piers Blombery

Peter MacCallum Cancer Centre, Melbourne, VIC, Australia

L

Lars Bullinger

B

Brenda Chyla

Abbvie, North Chicago, Illinois, United States

H

Hyun Yong Jin

12Genentech, Inc, South San Francisco, CA

Y

Yanwen Jiang

12Genentech, Inc, South San Francisco, CA

S

Stephan Stilgenbauer

Division of CLL, Department of Internal Medicine III, Ulm University, Ulm, Germany

M

Michael Hallek

Department I of Internal Medicine, Center of Integrated Oncology Aachen Bonn Cologne Düsseldorf, University Hospital of Cologne, Cologne, Germany

B

Barbara Eichhorst

Department I of Internal Medicine, Center of Integrated Oncology Aachen Bonn Cologne Düsseldorf, University Hospital of Cologne, Cologne, Germany

P

Petra Langerbeins

University Hospital, Cologne, Germany

K

Kirsten Fischer

Department I of Internal Medicine, Center of Integrated Oncology Aachen Bonn Cologne Düsseldorf, University Hospital of Cologne, Cologne, Germany

F

Frederik Damm

Charité–Universitätsmedizin Berlin, Berlin