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

Phase 3 Completed 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

Outcome

Missed primary endpoint

paper The estimated 3-year PFS in both groups was 62% (hazard ratio 1.11, 95% confidence interval 0.69-1.80, P = 0.6662). PMID 37922989 ↗

Publications

Ladetto M, Tavarozzi R, Zanni M, Evangelista A, Ferrero S, Tucci A, Botto B, Bolis S, Volpetti S, Zilioli VR, Puccini B, Arcari A, Pavone V, Gaidano G, Corradini P, Tani M, Cavallo F, Milone G, Ghiggi C, Pinto A, Pastore D, Ferreri AJM, Latte G, Patti C, Re F, Benedetti F, Luminari S, Pennese E, Bossi E, Boccomini C, Anastasia A, Bottelli C, Ciccone G, Vitolo U. Radioimmunotherapy versus autologous hematopoietic stem cell transplantation in relapsed/refractory follicular lymphoma: a Fondazione Italiana Linfomi multicenter, randomized, phase III trial. Ann Oncol. 2024 Jan;35(1):118-129. doi: 10.1016/j.annonc.2023.10.095. Epub 2023 Nov 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
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