Bendamustine, Gemcitabine and Vinorelbine (BeGEV) as Induction Therapy in Relapsed/Refractory Hodgkin's Lymphoma Patients
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01884441
|Contact: Armando Santoro, MD||+39 (0)2 8224 ext email@example.com|
|Contact: Rita Mazza, MD||+39 (0)2 8224 ext firstname.lastname@example.org|
|Istituto Clinico Humanitas||Recruiting|
|Rozzano, MI, Italy, 20089|
|Contact: Armando Santoro, MD +39 (0)2 8224 ext 4080 email@example.com|
|Contact: Rita Mazza, MD +39 (0)2 8224 ext 4780 firstname.lastname@example.org|
|Principal Investigator: Armando Santoro, MD|
|Sub-Investigator: Rita Mazza, MD|
|Principal Investigator:||Armando Santoro, MD||Istituto Clinico Humanitas|