ICML 2025 | JCOG1411 study: impact of early rituximab administration in advanced-stage low-tumor-burden FL

JCOG-1411 is a randomized Phase III trial to confirm the superiority of rituximab early administration over watchful waiting in untreated advanced stage low tumor burden follicular lymphoma. The results of primary analysis were reported at the last ASH meeting, and we reported the subgroup analysis results of JCOG-1411. A total of 292 patients were randomized with a median follow-up of 2.5 years. The event-free survival as a primary endpoint was significantly better in the rituximab arm than that in the watchful waiting arm. In the pre-planned subgroup analysis, male patients with histologic grade 3A, intermediate or high risk of FLIPI and FLIPI2 had a lower hazard risk of event-free survival in the rituximab arm. Importantly, median rituximab doses were 0 in the watchful waiting arm and 4 in the rituximab arm respectively. Furthermore, there was a slight imbalance in histologic transformation events and lymphoma disease occurred only in the watchful waiting arm, with 4 out of 5 diseases having histologic transformation. So we concluded that rituximab early administration has been confirmed to delay disease progression to high tumor burden and initiation of cytotoxic chemotherapy in patients with untreated advanced stage low tumor burden follicular lymphoma, including those with specific subgroups without a significant increase in the number of rituximab administrations.

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