Allo-hNHL (FluBuCy)

Summary

DSHNHL R3 is a randomized clinical phase II study. The main objective is to estimate the efficacy of rituximab as a prophylactic medication for prevention of graft-versus-host-disease after allogeneic peripheral stem cell transplantation in patients with a high risk relapse of aggressive B-cell Non-Hodgkin's lymphoma. The most important secondary objective is to estimate the efficacy of allogeneic stem cell transplantation in this clinical situation.

Timeline

Start

2004-04

Primary completion

2009-03

Completion

2011-04

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper The cumulative incidence of grade 2-4 acute graft-versus-host disease was 46% (95% CI 32-62) in the rituximab group and 42% (95% CI 29-59) in the no rituximab group PMID 24827808 ↗

paper Overall survival at 1 year for the whole study population was 52% (95% CI 41-62). PMID 24827808 ↗

Publications

• Glass B, Hasenkamp J, Wulf G, Dreger P, Pfreundschuh M, Gramatzki M, Silling G, Wilhelm C, Zeis M, Gorlitz A, Pfeiffer S, Hilgers R, Truemper L, Schmitz N; German High-Grade Lymphoma Study Group. Rituximab after lymphoma-directed conditioning and allogeneic stem-cell transplantation for relapsed and refractory aggressive non-Hodgkin lymphoma (DSHNHL R3): an open-label, randomised, phase 2 trial. Lancet Oncol. 2014 Jun;15(7):757-66. doi: 10.1016/S1470-2045(14)70161-5. Epub 2014 May 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rituximab	Monoclonal antibody	375 mg/m2	—
Background	Mycophenolate Mofetil	Small molecule	1 g	Oral
Background	Tacrolimus	Small molecule	—	—

Indications