Real-world clinical practice of acalabrutinib in chronic lymphocytic leukemia in Russia: interim results of a prospective observational study

I. V. Morozova; Морозова И. В.; V. I. Bakhtina; Бахтина В. И.; O. V. Berezina; Березина О. В.; S. A. Volkova; Волкова С. А.; N. N. Glonina; Глонина Н. Н.; A. I. Iskhakova; Исхакова А. И.; T. A. Mitina; Митина Т. А.; T. I. Pospelova; Поспелова Т. И.; A. V. Proydakov; Пройдаков А. В.; V. V. Turetskova; Турецкова В. В.; T. V. Shelekhova; Шелехова Т. В.; M. A. Pavlenko; Павленко М. А.; Evgeniy A. Nikitin; Никитин Евгений Александрович

doi:10.17650/1818-8346-2026-21-2-25-38

Real-world clinical practice of acalabrutinib in chronic lymphocytic leukemia in Russia: interim results of a prospective observational study

Authors: Morozova I.V.¹, Bakhtina V.I.², Berezina O.V.³, Volkova S.A.⁴, Glonina N.N.⁵, Iskhakova A.I.⁶, Mitina T.A.⁷, Pospelova T.I.³, Proydakov A.V.⁸, Turetskova V.V.⁴, Shelekhova T.V.¹, Pavlenko M.A.⁹, Nikitin E.A.¹⁰
Affiliations:
1. Saratov State Medical University named after V. I. Razumovsky, Ministry of Health of Russia
2. Regional Clinical Hospital, Krasnoyarsk
3. Novosibirsk State Medical University, Ministry of Health of Russia
4. Privolzhsky Research Medical University, Ministry of Health of Russia
5. Regional Clinical Hospital named after Prof. S.I. Sergeev
6. Republican Clinical Oncological Dispensary, Ministry of Health of the Republic of Bashkortostan
7. M.F. Vladimirskiy Moscow Regional Research Clinical Institute
8. Komi Republican Oncological Dispensary
9. AstraZeneca Pharmaceuticals
10. Botkin Hospital, Moscow Healthcare Department
Issue: Vol 21, No 2 (2026)
Pages: 25-38
Section: HEMATOLOGIC MALIGNANCIES: TREATMENT
Published: 25.06.2026
URL: https://oncohematology.abvpress.ru/ongm/article/view/1103
DOI: https://doi.org/10.17650/1818-8346-2026-21-2-25-38
ID: 1103

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Abstract
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Abstract

Background. Acalabrutinib, a second-generation Bruton tyrosine kinase inhibitor, has demonstrated high efficacy and an improved safety profile in randomized clinical trials in patients with chronic lymphocytic leukemia. However, real-world data remain essential to confirm its effectiveness and tolerability in broader, less selected patient populations, particularly in regions where such data are limited.

Aim. To evaluate the effectiveness, safety, and quality of life in patients with chronic lymphocytic leukemia treated with acalabrutinib in routine clinical practice in Russia.

Materials and methods. This prospective, multicenter observational study included adult patients with chronic lymphocytic leukemia who received acalabrutinib monotherapy according to physician decision. Patients were followed for up to 96 weeks. Primary endpoints included real-world progression-free survival and safety. Secondary endpoints included overall survival (OS), response rates, factors influencing treatment outcomes, and quality of life assessed using the FACT-Leu (Functional Assessment of Cancer Therapy – Leukemia) questionnaire. Survival was analyzed using the Kaplan–Meier method.

Results. The analysis included 85 patients (median age 65.5 years), of whom 78.8 % received therapy for relapse. High-risk features were frequent, including TP53 aberrations in 73 % of tested patients and unmutated IGHV in 65 %. At week 16, overall response (complete remission + partial remission) was achieved in 79 % of patients. By 18 months, complete response was observed in 65 % and partial response in 28 % of patients. With a median follow-up of 22.4 months, progression was recorded in 3 patients, and median OS was not reached; 1- and 2-year OS rates were 95 % and 90 %, respectively. Survival was not associated with TP53 status, IGHV status, or line of therapy. Diabetes mellitus was associated with inferior OS, likely due to infectious complications. Adverse events were reported in 21.2 % of patients, most commonly infections. Cardiovascular toxicity was infrequent. Quality of life (FACT-Leu scale) significantly improved over time (p < 0.001).

Conclusion. In a real-world Russian cohort, acalabrutinib demonstrated high efficacy, rapid and durable responses, and a favorable safety profile, including in patients with high-risk disease and significant comorbidity. These findings support the broad applicability of acalabrutinib in routine clinical practice.

Keywords

chronic lymphocytic leukemia, acalabrutinib, real-world practice, progression-free survival, overall survival, quality of life, safety

About the authors

I. V. Morozova

Saratov State Medical University named after V. I. Razumovsky, Ministry of Health of Russia

Email: eugene_nikitin@mail.ru
ORCID iD: 0000-0001-6304-9619

University Clinical Hospital No.3 named after V. Ya. Shustov

Russian Federation, 112 Bolshaya Kazachya St., Saratov 410012

University Clinical Hospital No.3 named after V. Ya. Shustov

Russian Federation, 112 Bolshaya Kazachya St., Saratov 410012

M. A. Pavlenko

AstraZeneca Pharmaceuticals

Email: eugene_nikitin@mail.ru
Russian Federation, Build. 1, 21 1st Krasnogvardeiskiy Proezd, Moscow 123112

Evgeniy A. Nikitin

Botkin Hospital, Moscow Healthcare Department

Author for correspondence.
Email: eugene_nikitin@mail.ru
ORCID iD: 0000-0002-2490-1263
Russian Federation, 5 2nd Botkinskiy Proezd, Moscow 125284

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