NCT01884441

Bendamustine, Gemcitabine and Vinorelbine (BeGEV) as Induction Therapy in Relapsed/Refractory Hodgkin's Lymphoma Patients

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (estimated)
• Sponsor: Armando Santoro, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Test of bendamustine in combination with gemcitabine and vinorelbine could contribute to a higher response rate with the reduction of toxic side effects

Detailed description

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 (HL). 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).

Conditions

• Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	Bendamustine	Schedule: Day 2: Bendamustine 90mg/mq Day 3: Bendamustine 90mg/mq for a maximum of 4 cycles
DRUG	Gemcitabine	Day 1: Gemcitabine 800mg/mq, Day 4: Gemcitabine 800mg/mq for a maximum of 4 cycles
DRUG	Vinorelbine	Day 1 Vinorelbine 20mg/mq for a maximum of 4 cycles

Timeline

• Start date: 2011-07-01
• Primary completion: 2014-07-01
• Completion: 2016-07-01
• First posted: 2013-06-24
• Last updated: 2014-01-29

Locations

1 site across 1 country: Italy