Clinical Trial

Shortened vs Standard Chemotherapy Combined With Immunotherapy for the Initial Treatment of Patients With High Tumor Burden Follicular Lymphoma

Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
FIL\_FOLL19 is an open-label, multicenter, randomized phase III trial. The sponsor of this clinical trial is Fondazione Italiana Linfomi (FIL). The Primary Objective of the study is to demonstrate that, in patients with newly diagnosed, advanced stage Follicular Lymphoma (FL) with high tumor burden according to the Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria, a treatment strategy that reduces the number of chemotherapy cycles in case of early response to immunochemotherapy is not inferior compared to standard therapy at full dose in terms of Progression-Free Survival (PFS).
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2021-09-16; most recent amendment 2026-06-24.
Status change: Recruiting → Active, Not Recruiting 2025-09-01
Status change: Not Yet Recruiting → Recruiting 2022-03-30
Trial Details
NCT Number NCT05058404
Lead Sponsor Fondazione Italiana Linfomi - ETS
Conditions Follicular Lymphoma
Enrollment 605 participants
Start Date 2021-12-01
Primary Completion 2028-07 (estimated)
Study Completion 2030-07 (estimated)
Updated on ClinicalTrials.gov 2026-06-26