Overview

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

Status:
Not yet recruiting

Trial end date:
2030-07-01

Target enrollment:

Participant gender:

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).

Phase:

Phase 3

Details

Lead Sponsor:

Fondazione Italiana Linfomi ONLUS

Treatments:

Bendamustine Hydrochloride
Cyclophosphamide
Doxorubicin
Prednisone
Rituximab
Vincristine