New Reference: RiTUXimab alone for Follicular Lymphoma

Study

Randomised, open-label, phase 3 trial (NCT00112931)

Advanced stage (II–IV), asymptomatic, low tumour burden follicular lymphoma (grade 1–3a)

Watchful waiting vs. rituximab induction vs. rituximab induction + maintenance

Efficacy

median Time To New Treatment (TTNT): 5.6 yrs vs. 14.8 yrs vs. NR (watchful waiting vs. induction vs. maintenance)

15-yr no treatment start: 34% vs. 48% vs. 65%

TTNT HR: 0.55 [0.38–0.80] (induction vs. watchful waiting), 0.36 [0.26–0.50] (maintenance vs. watchful waiting), 0.66 [0.43–1.00] (maintenance vs. induction)

15-yr no second treatment: 79% vs. 85% vs. 86%

TT2NT HR: 0.57 [0.33–1.00] (maintenance vs. watchful waiting)

15-yr OS: 68% vs. 66% vs. 73%

15-yr high-grade transformation: 20% vs. 15% vs. 17%

Safety

Grade ≥3 AEs: infections (0 vs. 0 vs. 5), allergic reactions (0 vs. 1 vs. 2), neutropenia (0 vs. 0 vs. 4)

Second primary malignancies: 23% vs. 21% vs. 16%

Lancet Haematol 2025;12e:e335

Northend M,Wilson W,Ediriwickrema K Early rituximab monotherapy versus watchful waiting for advanced stage, asymptomatic, low tumour burden follicular lymphoma: long-term results of a randomised, phase 3 trial

http://doi.org/10.1016/S2352-3026(24)00400-3

Reviewed by Ulas D. Bayraktar, MD on May 5, 2025