Rituximab and Lenalidomide Plus Ibrutinib Therapy Shows Promising Activity, Manageable Toxicity in Real-World Setting for Relapsed/Refractory DLBCL
Key Clinical Summary
- Design/Population: A retrospective, single-center study (N = 24) evaluated rituximab and lenalidomide plus ibrutinib (RLI) among patients with relapsed/refractory (R/R) NHL, including DLBCL (n = 18), PCNSL (n = 2), MCL (n = 2), and MZL (n = 2).
- Key Outcomes: The regimen achieved an ORR of 46% (95% CI, 24–67), with CR 33% and PR 13%. Median DoR was 31 months, PFS 6.3 months, and OS 8.0 months; the median time to response 2 months.
- Clinical Relevance: Rituximab, lenalidomide, and ibrutinib demonstrated promising activity and manageable toxicity (fatigue and neutropenia 42%, infections 33%), supporting further evaluation as a viable treatment option in R/R NHL.
The combination of rituximab, lenalidomide, and ibrutinib (RLI) demonstrated encouraging efficacy and safety among patients with relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL), including diffuse large B-cell lymphoma (DLBCL), according to study results published in Indian Society of Hematology and Blood Transfusion.
Previous research has found the combination of rituximab, lenalidomide, and ibrutinib to be efficacious for patients with relapsed/refractory non-Hodgkin lymphoma, however, research is limited on its efficacy in a real-world setting. To address this, researchers conducted a retrospective single-center study to determine the safety and efficacy of rituximab, lenalidomide, and ibrutinib.
Overall, 24 patients were included. Of those treated with rituximab, lenalidomide, and ibrutinib, 18 had diffuse large B-cell lymphoma (DLBCL), 2 with primary CNS lymphoma (PCNSL), 2 with mantle cell lymphoma (MCL), and 2 with marginal zone lymphoma (MZL).
The overall response rate (ORR) was 46% (95% confidence interval [CI], 24 to 67), including 33% complete responses (CR) and 13% partial responses (PR). The median time to response was 2 months (range, 1.7 to 3.8) and the median duration of response (DoR) was 31 months (range, 0.6 to 46+).
Additionally, the median progression-free survival (PFS) was 6.3 months (95% CI, 0.0 to 25.1), and median overall survival (OS) was 8.0 months (95% CI, 2.2 to 13.7).
In terms of safety, the most common adverse events were fatigue (42%), neutropenia (42%), and infections (33%).
The researchers concluded, “Our results suggest that RLI is a viable therapeutic option with promising activity and a favorable toxicity profile in patients with R/R NHL.”
Source:
Derya Koyun, Uğur Şahin, Ayla Gökmen, Muhit Özcan. Real-World Efficacy and Safety of the Combination of Rituximab, Lenalidomide, and Ibrutinib in Patients with Relapsed and/or Refractory Non-Hodgkin Lymphoma. Indian Journal of Hematology and Blood Transfusion. Published online July 2025. doi:10.1007/s12288-024-01897-6
