The Real-World Experience With Single Agent Ibrutinib in Relapsed/Refractory CLL

Clin Lymphoma Myeloma Leuk. 2022 Mar;22(3):169-173. doi: 10.1016/j.clml.2021.09.010. Epub 2021 Sep 15.


Introduction/background: The emergence of novel agents targeting the B-cell receptor pathway and BCL-2 has significantly changed the therapeutic landscape of CLL. We evaluated the safety and efficacy of single-agent ibrutinib in relapsed/refractory CLL in real-world settings.

Patients/methods: A total of 200 relapsed/refractory CLL patients with a median age of 68 were included in this retrospective, multicenter, non-interventional study. Data of the study were captured from the patient charts of the participating centers.

Results: The median for lines of previous chemotherapy was 2 (1-6); 62 (31.8%) patients had del17p and/or p53 mutations (del17p+/p53mut). Of the study group, 146 (75%) patients achieved at least PR, while 16 (8.7%) patients discontinued ibrutinib due to TEA. The most common drug-related adverse events were neutropenia (n: 31; 17.4%) and thrombocytopenia (n: 40; 22.3%), which were ≥ grade 3 in 9 (5%) and 5 (3.9%) patients, respectively. Pneumonia (n: 42; 23.7%) was the most common nonhematologic TEA. Atrial fibrillation (n: 5; 2.8%) and bleeding (n: 11; 6.3%) were relatively rare during the study period. Within a median follow-up period of 17 (1-74) months, 42 (21%) patients died. The estimated median OS of the study cohort was 52 months. Only the response to ibrutinib (CR/PR vs. SD/PD) was significantly associated with OS.

Conclusion: Our results indicate good safety and efficacy for single-agent ibrutinib in R/R CLL in daily practice.

Keywords: Bruton tyrosine kinase; Chronic lymphocytic leukemia; Ibrutinib; Relapsed/refractory; p53 mutation.

Publication types

  • Multicenter Study

MeSH terms

  • Adenine / analogs & derivatives
  • Humans
  • Leukemia, Lymphocytic, Chronic, B-Cell* / drug therapy
  • Leukemia, Lymphocytic, Chronic, B-Cell* / genetics
  • Neoplasm Recurrence, Local / drug therapy
  • Piperidines
  • Pyrazoles / adverse effects
  • Pyrimidines / adverse effects
  • Retrospective Studies


  • Piperidines
  • Pyrazoles
  • Pyrimidines
  • ibrutinib
  • Adenine