drugset / Trial / NCT03159897

FIL Study on ABVD DD-DI as Upfront Therapy in HL.

NCT03159897

Phase 3 Completed 500 enrolled Fondazione Italiana Linfomi - ETS
RandomizedParallel-groupOpen-labelTreatment

Summary

The FIL-Rouge is a randomized, open-label, multicenter, phase III, 2-arm study. The primary objective is to compare efficacy and tolerability of the intensified variant 'dose-dense/dose-intense ABVD' (ABVD DD-DI) with an interim PET response-adapted ABVD program as upfront therapy in advanced-stage classical Hodgkin Lymphoma (HL).

Timeline

Start
2017-08-01
Primary completion
2021-11-02
Completion
2024-11-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Bleomycin Unknown 10000 unknown Intravenous
Subject Dacarbazine Small molecule 375 mg/m2 Intravenous
Subject Doxorubicin Other / unclassified 25 mg/m2 Intravenous
Subject Doxorubicin Other / unclassified 35 mg/m2 Intravenous
Subject Vinblastine Small molecule 6 mg/m2 Intravenous