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
http://doi.org/10.1016/S2352-3026(24)00400-3
Reviewed by Ulas D. Bayraktar, MD on May 5, 2025
