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September 2, 2026British Journal of HaematologyOpen Access

SAKK 35/14 randomized trial of rituximab with or without ibrutinib for patients with untreated follicular lymphoma

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Authors

MPMaria Cristina PirosaMBMarianne BrodtkorbSSSämi Schär

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Overview

Randomized trial reports similar complete remission but improved progression-free survival trends with rituximab plus ibrutinib in follicular lymphoma, indicating potential clinical benefit.

Key Points

  • To evaluate the efficacy and safety of adding ibrutinib to rituximab compared with rituximab plus placebo in patients with untreated, advanced follicular lymphoma requiring systemic therapy.
  • Randomized phase II trial (SAKK 35/14) conducted by the Swiss Group for Clinical Cancer Research and Nordic Lymphoma Group in patients with untreated advanced follicular lymphoma.
  • Patients received rituximab (375 mg/m² intravenously for 4 weeks, followed by maintenance every 2 months for 24 months) combined with either placebo (arm A) or daily ibrutinib (560 mg for 24 months, arm B).
  • The primary endpoint of complete remission rate at 24 months was 36% in arm A and 40% in arm B, demonstrating no statistically significant difference.
  • Three-year progression-free survival was 36% in arm A versus 45% in arm B (hazard ratio 0.64, p = 0.057), with 3-year overall survival at approximately 96% in both arms.
  • Arm B had a higher incidence of grade ≥3 adverse events, but complications were manageable and no toxic deaths occurred.

Cite This Study

Pirosa et al. (2026) studied this question.

synapsesocial.com/papers/6a97e318c562ede874ec7a4ehttps://doi.org/10.1111/bjh.70801
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