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Peer-reviewedCC BYHemaSphere

Impact of venetoclax-based therapies on CLL-associated autoimmune cytopenias: A retrospective study conducted by ERIC.

95 more authors

60 listed; 107 in total.

40 affiliations
  1. 1Division of Hematology, A.O.U. Città della Salute e della Scienza di Torino and Department of Molecular Biotechnology and Health Sciences University of Torino Torino Italy.
  2. 2Institute of Applied Biosciences Centre for Research and Technology Hellas Thessaloniki Greece.
  3. 3Department of Hematology Santa Croce e Carle Hospital Cuneo Italy.
  4. 4Department of Medicine, Faculty of Medicine Kuwait University Kuwait City Kuwait.
  5. 5Hematology Unit, Department of Medicine University of Padova Padova Italy.
  6. 6Hematology 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.
  7. 7Department of Internal Medicine - Hematology and Oncology University Hospital Brno and Faculty of Medicine, Masaryk University Brno Czech Republic.
  8. 8Division of Hematology, Department of Internal Medicine University Hospital Zagreb Zagreb Croatia.
  9. 9Haematology St. George's University Hospital London United Kingdom.
  10. 10Haematology Department Medical University Hospital Bialystok Poland.
  11. 11Department of Hematology and Oncology Wroclaw Medical University Wroclaw Poland.
  12. 12Oncology Support Centre for Clinical Trials Alfred Sokolowski Specialist Hospital in Walbrzych Walbrzych Poland.
  13. 13Department of Medical Oncology Dana-Farber Cancer Institute Boston Massachusetts United States.
  14. 14Hematology Unit, 1st Department of Internal Medicine AUTH, AHEPA Hospital Thessaloniki Greece.
  15. 15Servicio de Hematología Consorcio Hospital General Universitario de Valencia, Fundación de Investigación Hospital General Universitario de Valencia Valencia Spain.
  16. 16Department of Hematology Fundacion Jimenez Diaz University Hospital, Health Research Institute IIS-FJD Madrid Spain.
  17. 17Division of Internal Medicine, Hematology Unit ASL Vercelli Vercelli Italy.
  18. 18Department of Hematology, Niguarda Cancer Center ASST Grande Ospedale Metropolitano Niguarda Milano Italy.
  19. 19Department of Hematology and Bone Marrow transplantation Unit National and Kapodistrian University of Athens Laikon General Hospital Athens Greece.
  20. 20Clinical Haematology Belfast City Hospital Belfast United Kingdom.
  21. 21Department of Hematology Transplantation and Internal Medicine Medical University of Warsaw Warsaw Poland.
  22. 22Division of Hematology ASST Sette Laghi - Ospedale di Circolo di Varese Varese Italy.
  23. 23Hematology-Oncology and Stem Cell Transplantation Unit, Department of Onco-Hematology and Innovative Diagnostics Istituto Nazionale Tumori IRCCS Fondazione G. Pascale Napoli Italy.
  24. 24Dr. B.R.A. IRCH, All India Institute of Medical Sciences (AIIMS) New Delhi India.
  25. 25Hematology Department Infanta Leonor University Hospital Madrid Spain.
  26. 26First Department of Internal Diseases Medical University of Plovdiv, Clinical Hematology Clinic, St. George University Hospital for Active Treatment Plovdiv Bulgaria.
  27. 27Department of Hematology and Bone Marrow Transplantation Polish Red Cross Maritime Hospital Gdynia Poland.
  28. 28Department of Hematology The First Affiliated Hospital of Nanjing Medical University Nanjing China.
  29. 29Department of General Hematology and Internal Medicine Copernicus Memorial Hospital Lodz Poland.
  30. 30Department of Hematology Medical University of Lodz Lodz Poland.
  31. 31Department of Nursing, Faculty of Nursing and Midwifery Wroclaw Medical University Wroclaw Poland.
  32. 32Department of Hematology Dubrava University Hospital Zagreb Croatia.
  33. 33Clinical Department of Hematology, Cell Therapies and Internal Diseases Wroclaw Medical University Wroclaw Poland.
  34. 34Department of Hematology, Oncology, and Chemotherapy, S. P. Botkin's City Hospital Russian Medical Academy of Continuous Professional Education Moscow Russia.
  35. 35Department of Hematology, Shamir Medical Center, Zerifin and Sackler Faculty of Medicine Tel Aviv University Tel Aviv Israel.
  36. 36Department of Haematology, Faculty of Medicine School of Health Sciences University of Ioannina Ioannina Greece.
  37. 37Department of Hemato-Oncology, Faculty of Medicine and Dentistry Palacký University and University Hospital Olomouc Olomouc Czech Republic.
  38. 38Department of Hematology Hospital Universitario de Burgos, Instituto de Investigación Biosanitaria de Burgos (IBioBURGOS) Burgos Spain.
  39. 39Hematology Clinic, ASUFC Udine Italy.
  40. 40Department of Hematology, Tel Aviv Sourasky Medical Center and Faculty of Medicine Tel Aviv University Tel Aviv Israel.

Abstract

The impact of venetoclax-based therapies on autoimmune cytopenias (AIC) in patients with chronic lymphocytic leukemia (CLL) is largely unknown. This study aimed to evaluate preexisting and treatment-emergent AIC in patients with CLL treated with venetoclax, focusing on the differential impact of venetoclax monotherapy versus venetoclax-based combinations. In this retrospective multicenter study, data from 1720 patients were collected; 23.1% received venetoclax single agent and 76.9% venetoclax combinations (mostly containing anti-CD20 monoclonal antibodies and/or BTK inhibitors). Combination regimens were used in 97.7% of treatment-naïve (TN) patients and 65.8% of patients with relapsed/refractory (R/R) CLL. Preexisting AIC were reported in 11.7% of patients (8.7% in TN and 13.4% in R/R, P = 0.005). CLL-related genetic risk factors and disease outcomes did not differ in patients with and without preexisting AIC. Irrespective of treatment type, venetoclax therapy resulted in AIC resolution or improvement in 63% of patients with active or controlled AIC. Treatment-emergent AIC occurred in 2.6% of patients (2% in TN and 2.9% in R/R, not statistically significant). AIC episodes were reported in 4.3% of patients treated with venetoclax monotherapy and in 2.1% of those treated with venetoclax-based combinations (P = 0.02). After standard management, AIC was considered resolved or controlled in 82% of the patients, with no substantial difference between treatment groups. Venetoclax-based therapies have a beneficial impact on the outcome of CLL-associated preexisting AIC. Treatment-emergent AIC is a rare and generally manageable event. Although more frequent with venetoclax monotherapy in unadjusted analysis, this association was attenuated after adjustment for baseline prognostic factors.

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BibTeX
@article{vitale2026impact,
  title = {{Impact of venetoclax-based therapies on CLL-associated autoimmune cytopenias: A retrospective study conducted by ERIC.}},
  author = {Candida Vitale and Thomas Chatzikonstantinou and Christina Papangelou and Francesca Perutelli and Maria Chiara Montalbano and Giulia Bondielli and Elia Boccellato and Salem Alshemmari and Francesco Angotzi and Miguel Arguello-Tomas and Tomas Arpas and Sandra Bašić-Kinda and Sotiria Besikli-Dimou and Łukasz Bołkun and Tomasz Buczek and Aleksandra Butrym and Katherine Chapis and Sofia Chatzileontiadou and Rosa Collado and Raul Cordoba Mascuñano and Lorenzo De Paoli and Marina Deodato and Maria Dimou and David Donaldson and Joanna Drozd-Sokołowska and Salem Elias and Andrea Ferrario and Alberto Fresa and Anna Maria Frustaci and Rocío García-Serra and Ajay Gogia and Isabel González-Gascón-Y-Marín and Vasko Graklanov and Maria Hryniewiecka and Zhu Huayuan and Elzbieta Iskierka-Jażdżewska and Paula Jablonowska-Babij and Ozren Jaksic and Elzbieta Kalicińska and Maria Kislova and Maya Koren-Michowitz and Epameinondas Koumpis and Zuzana Kubová and Jorge Labrador and Pietro Lauzzana and Shai Levi and Francesca Martini and Mariia Mikhaleva and Eva Minga and Riccardo Moia and Elżbieta Morawiec-Szymonik and Marta Morawska and Femke V M Mulder and Roberta Murru and Jacopo Olivieri and Ewa Paszkiewicz-Kozik and Lata Rani and Josep Maria Roncero and Wojciech Salamon and Alessandro Sanna},
  journal = {HemaSphere},
  year = {2026},
  month = nov,
  doi = {10.1002/hem3.70522},
  url = {https://europepmc.org/article/MED/42997681},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - Impact of venetoclax-based therapies on CLL-associated autoimmune cytopenias: A retrospective study conducted by ERIC.
AU  - Candida Vitale
AU  - Thomas Chatzikonstantinou
AU  - Christina Papangelou
AU  - Francesca Perutelli
AU  - Maria Chiara Montalbano
AU  - Giulia Bondielli
AU  - Elia Boccellato
AU  - Salem Alshemmari
AU  - Francesco Angotzi
AU  - Miguel Arguello-Tomas
AU  - Tomas Arpas
AU  - Sandra Bašić-Kinda
AU  - Sotiria Besikli-Dimou
AU  - Łukasz Bołkun
AU  - Tomasz Buczek
AU  - Aleksandra Butrym
AU  - Katherine Chapis
AU  - Sofia Chatzileontiadou
AU  - Rosa Collado
AU  - Raul Cordoba Mascuñano
AU  - Lorenzo De Paoli
AU  - Marina Deodato
AU  - Maria Dimou
AU  - David Donaldson
AU  - Joanna Drozd-Sokołowska
AU  - Salem Elias
AU  - Andrea Ferrario
AU  - Alberto Fresa
AU  - Anna Maria Frustaci
AU  - Rocío García-Serra
AU  - Ajay Gogia
AU  - Isabel González-Gascón-Y-Marín
AU  - Vasko Graklanov
AU  - Maria Hryniewiecka
AU  - Zhu Huayuan
AU  - Elzbieta Iskierka-Jażdżewska
AU  - Paula Jablonowska-Babij
AU  - Ozren Jaksic
AU  - Elzbieta Kalicińska
AU  - Maria Kislova
AU  - Maya Koren-Michowitz
AU  - Epameinondas Koumpis
AU  - Zuzana Kubová
AU  - Jorge Labrador
AU  - Pietro Lauzzana
AU  - Shai Levi
AU  - Francesca Martini
AU  - Mariia Mikhaleva
AU  - Eva Minga
AU  - Riccardo Moia
AU  - Elżbieta Morawiec-Szymonik
AU  - Marta Morawska
AU  - Femke V M Mulder
AU  - Roberta Murru
AU  - Jacopo Olivieri
AU  - Ewa Paszkiewicz-Kozik
AU  - Lata Rani
AU  - Josep Maria Roncero
AU  - Wojciech Salamon
AU  - Alessandro Sanna
PY  - 2026
DA  - 2026/11/06
JO  - HemaSphere
DO  - 10.1002/hem3.70522
UR  - https://europepmc.org/article/MED/42997681
AB  - The impact of venetoclax-based therapies on autoimmune cytopenias (AIC) in patients with chronic lymphocytic leukemia (CLL) is largely unknown. This study aimed to evaluate preexisting and treatment-emergent AIC in patients with CLL treated with venetoclax, focusing on the differential impact of venetoclax monotherapy versus venetoclax-based combinations. In this retrospective multicenter study, data from 1720 patients were collected; 23.1% received venetoclax single agent and 76.9% venetoclax combinations (mostly containing anti-CD20 monoclonal antibodies and/or BTK inhibitors). Combination regimens were used in 97.7% of treatment-naïve (TN) patients and 65.8% of patients with relapsed/refractory (R/R) CLL. Preexisting AIC were reported in 11.7% of patients (8.7% in TN and 13.4% in R/R, P = 0.005). CLL-related genetic risk factors and disease outcomes did not differ in patients with and without preexisting AIC. Irrespective of treatment type, venetoclax therapy resulted in AIC resolution or improvement in 63% of patients with active or controlled AIC. Treatment-emergent AIC occurred in 2.6% of patients (2% in TN and 2.9% in R/R, not statistically significant). AIC episodes were reported in 4.3% of patients treated with venetoclax monotherapy and in 2.1% of those treated with venetoclax-based combinations (P = 0.02). After standard management, AIC was considered resolved or controlled in 82% of the patients, with no substantial difference between treatment groups. Venetoclax-based therapies have a beneficial impact on the outcome of CLL-associated preexisting AIC. Treatment-emergent AIC is a rare and generally manageable event. Although more frequent with venetoclax monotherapy in unadjusted analysis, this association was attenuated after adjustment for baseline prognostic factors.
SN  - 2572-9241
ER  -