drugset / Trial / NCT01827605

A Phase III Multicenter, Randomized Study Comparing RIT Vs ASCT in Patients With Relapsed/Refractory (FL)

NCT01827605

Phase 3 Unknown 159 enrolled Fondazione Italiana Linfomi - ETS
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase III, multicenter, open-label, randomized and controlled study to compare the efficacy of a consolidation therapy with RIT versus ASCT in patients with FL in CR or PR after second or third line chemotherapy supplemented with rituximab.

Timeline

Start
2012-01
Primary completion
2019-10
Completion
2024-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cytarabine Small molecule 200 mg/m2 Intravenous
Subject Etoposide Small molecule 100 mg/m2 Intravenous
Subject Melphalan Small molecule 140 mg/m2 Intravenous
Subject carmustine Small molecule 300 mg/m2 Intravenous
Background Lenograstim Protein / enzyme biologic 5 ug/kg Subcutaneous
Background filgrastim Protein / enzyme biologic 5 ug/kg Subcutaneous

Indications