A Phase II Study of IGEV +/- Bortezomib Before Hign Dose Consolidation in Relapsed/Refractory Hodgkin's Lymphoma

Phase 2 Completed 13 enrolled Istituto Clinico Humanitas

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate if the addition of Bortezomib (Velcade) to IGEV combination (Ifosfamide, Gemcitabine and Vinorelbine) in patients with relapsed/refractory Hodgkin's lymphoma increases the rate of complete remission (PET negativity) at transplantation.

Timeline

Start: 2008-02
Primary completion: 2008-04
Completion: 2010-02

Publications

Background Santoro A, Magagnoli M, Spina M, Pinotti G, Siracusano L, Michieli M, Nozza A, Sarina B, Morenghi E, Castagna L, Tirelli U, Balzarotti M. Ifosfamide, gemcitabine, and vinorelbine: a new induction regimen for refractory and relapsed Hodgkin's lymphoma. Haematologica. 2007 Jan;92(1):35-41. doi: 10.3324/haematol.10661.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bortezomib	Small molecule	1.3 mg/m2	—
Background	2-MERCAPTOETHANESULFONIC ACID	Small molecule	—	—
Background	Gemcitabine	Small molecule	800 mg/m2	—
Background	Ifosfamide	Small molecule	2000 mg/m2	—
Background	Prednisone	Other / unclassified	100 mg	—
Background	Vinorelbine	Small molecule	20 mg/m2	—

A Phase II Study of IGEV +/- Bortezomib Before Hign Dose Consolidation in Relapsed/Refractory Hodgkin's Lymphoma

Summary

Timeline

Publications

Drugs

Indications