Comparison of High-Dose Chemotherapy + Rituximab and CHOP + Rituximab in High-Risk Follicular Lymphoma

Phase 3 Unknown 240 enrolled Azienda Ospedaliera San Giovanni Battista Gruppo Italiano Studio Linfomi · collab Gruppo Italiano Trapianto di Midollo Osseo · collab Hoffmann-La Roche · collab University of Turin, Italy · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine whether an intensified treatment plus Rituximab followed by autologous transplantation is superior to a conventional chemotherapy regimen also supplemented with Rituximab.

Timeline

Start: 2000-03
Primary completion: —
Completion: —

Outcome

Met primary endpoint

paper the 4-year EFS was 28% and 61%, respectively (P < .001) PMID 18239086 ↗

paper R-HDS ensures superior disease control and molecular outcome than CHOP-R, but no OS improvement PMID 18239086 ↗

Publications

Ladetto M, De Marco F, Benedetti F, Vitolo U, Patti C, Rambaldi A, Pulsoni A, Musso M, Liberati AM, Olivieri A, Gallamini A, Pogliani E, Rota Scalabrini D, Callea V, Di Raimondo F, Pavone V, Tucci A, Cortelazzo S, Levis A, Boccadoro M, Majolino I, Pileri A, Gianni AM, Passera R, Corradini P, Tarella C; Gruppo Italiano Trapianto di Midollo Osseo (GITMO); Intergruppo Italiano Linfomi (IIL). Prospective, multicenter randomized GITMO/IIL trial comparing intensive (R-HDS) versus conventional (CHOP-R) chemoimmunotherapy in high-risk follicular lymphoma at diagnosis: the superior disease control of R-HDS does not translate into an overall survival advantage. Blood. 2008 Apr 15;111(8):4004-13. doi: 10.1182/blood-2007-10-116749. Epub 2008 Jan 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rituximab	Monoclonal antibody	—	—