Bendamustine, Gemcitabine and Vinorelbine (BeGEV) as Induction Therapy in Relapsed/Refractory Hodgkin's Lymphoma Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01884441|
Recruitment Status : Unknown
Verified January 2014 by Armando Santoro, MD, Istituto Clinico Humanitas.
Recruitment status was: Recruiting
First Posted : June 24, 2013
Last Update Posted : January 29, 2014
|Condition or disease||Intervention/treatment||Phase|
|Hodgkin's Lymphoma||Drug: Bendamustine Drug: Gemcitabine Drug: Vinorelbine||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||59 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||July 2011|
|Estimated Primary Completion Date :||July 2014|
|Estimated Study Completion Date :||July 2016|
Bendamustine, Gemcitabine and Vinorelbine (BeGEV)
Day 2: Bendamustine 90mg/mq Day 3: Bendamustine 90mg/mq for a maximum of 4 cycles
Other Name: Ribomustin
Day 1: Gemcitabine 800mg/mq, Day 4: Gemcitabine 800mg/mq for a maximum of 4 cycles
Other Name: Gemzar
Day 1 Vinorelbine 20mg/mq for a maximum of 4 cycles
Other Name: Navelbine
- Response Rate [ Time Frame: 3 months ]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.
- overall response rate [ Time Frame: 3 months ]To assess the response rate after BeGEV in terms of overall response rate (ORR) =Complete Response (CR) plus Partial Response (PR)).
- mobilization potential of the combination [ Time Frame: 3 months ]To evaluate the mobilization potential of BeGEV.
- toxicity of the combination [ Time Frame: 3 months ]To evaluate the toxicity of BeGEV in terms of haematological and extra-haematological side effects according to CTCAE definitions v 3.0.
- Progression free survival (PFS), Overall Survival (OS). [ Time Frame: 2 years ]Progression free survival and overall survival
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01884441
|Contact: Armando Santoro, MD||+39 (0)2 8224 ext firstname.lastname@example.org|
|Contact: Rita Mazza, MD||+39 (0)2 8224 ext email@example.com|
|Istituto Clinico Humanitas||Recruiting|
|Rozzano, MI, Italy, 20089|
|Contact: Armando Santoro, MD +39 (0)2 8224 ext 4080 firstname.lastname@example.org|
|Contact: Rita Mazza, MD +39 (0)2 8224 ext 4780 email@example.com|
|Principal Investigator: Armando Santoro, MD|
|Sub-Investigator: Rita Mazza, MD|
|Principal Investigator:||Armando Santoro, MD||Istituto Clinico Humanitas|