Phase II Study With Bendamustine, Gemcitabine and Vinorelbine (BeGEV) as Induction Therapy in Relapsed/Refractory Hodgkin's Lymphoma Patients Before High Dose Chemotherapy With Autologous Hematopoietic Stem Cells Transplant
The aim of this study is to evaluate bendamustine, gemcitabine and vinorelbine (BeGEV)
scheme efficacy as induction therapy to high dose chemotherapy with Allogeneic Hematopoietic
Stem-Cell Transplantation (AHSCT) for patients with relapsed/refractory Hodglin's Lymphoma
Four BeGEV courses repeated every 3 weeks in the absence of any reasons listed in the
paragraph 7.5; whenever an objective response is observed at disease evaluation performed
after IV cycle patients undergo to high dose chemotherapy with AHSCT (conditioning regimens
based on preference of each Centre).
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
response rate after BeGEV in terms of Complete Response (CR)evaluated by fludeoxyglucose Positron emission tomography (FDG-PET) and Computed Tomography (CT-scan) after four cycles.
Armando Santoro, MD
Istituto Clinico Humanitas
Italy: Ministry of Health