A Randomized Phase IIb Placebo-Controlled Study of R-ICE Chemotherapy With and Without SGN-40 for Patients With DLBCL

Phase 2 Terminated 151 enrolled Seagen Inc. Genentech, Inc. · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomized trial to estimate the activity of R-ICE plus SGN-40 vs. R-ICE plus placebo in patients with DLBCL. The study will assess safety and tolerability and will measure any additional clinical benefit observed in patients receiving SGN-40.

Timeline

Start: 2007-09
Primary completion: 2009-12
Completion: 2011-05

Publications

Results Fayad L, Ansell SM, Advani R, Coiffier B, Stuart R, Bartlett NL, Forero-Torres A, Kuliczkowski K, Belada D, Ng E, Drachman JG. Dacetuzumab plus rituximab, ifosfamide, carboplatin and etoposide as salvage therapy for patients with diffuse large B-cell lymphoma relapsing after rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone: a randomized, double-blind, placebo-controlled phase 2b trial. Leuk Lymphoma. 2015;56(9):2569-78. doi: 10.3109/10428194.2015.1007504. Epub 2015 Feb 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	dacetuzumab	Monoclonal antibody	—	Intravenous
Background	Carboplatin	Small molecule	—	Intravenous
Background	Etoposide	Small molecule	100 mg/m2	Intravenous
Background	Ifosfamide	Small molecule	5000 mg/m2	Intravenous
Background	Rituximab	Monoclonal antibody	375 mg/m2	Intravenous

A Randomized Phase IIb Placebo-Controlled Study of R-ICE Chemotherapy With and Without SGN-40 for Patients With DLBCL

Summary

Timeline

Publications

Drugs

Indications