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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Hodgkin's Lymphoma

Intervention / Treatment
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* Drug: Bendamustine
* Drug: Gemcitabine
* Drug: Vinorelbine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: relapsed/refractory disease after receiving one line of standard chemotherapy history of classical Hodgkin's Lymphoma (HL) Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 at least one site of measurable nodal disease at baseline ≥ 1.5 cm Absolute Neutrophils Count (ANC) ≥ 1.5 x 109/L; Platelets count ≥ 75 x 109/L Exclusion Criteria: Diagnosis of Nodular lymphocyte predominant Hodgkin's lymphoma (NLPHL) prior radiation therapy ≤ 3 weeks prior to start of study treatment any concurrent anti-cancer therapy evidence of another malignancy not in remission or history of such a malignancy within the last 2 years. aspartate aminotransferase (AST/SGOT) and/or alanine aminotransferase (ALT/SGPT) ≥ 2.5 x upper limit of normal (ULN) or ≥ 5.0 x ULN if the transaminase elevation is due to disease involvement known history of Human immunodeficiency virus (HIV)seropositivity hepatitis B virus (HBV) or hepatitis B virus (HCV)active hepatitis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BeGEV<br>Bendamustine, Gemcitabine and Vinorelbine (BeGEV) | Drug: Bendamustine<br>* Schedule: Day 2: Bendamustine 90mg/mq Day 3: Bendamustine 90mg/mq for a maximum of 4 cycles<br>* Other names: Ribomustin;Drug: Gemcitabine<br>* Day 1: Gemcitabine 800mg/mq, Day 4: Gemcitabine 800mg/mq for a maximum of 4 cycles<br>* Other names: Gemzar;Drug: Vinorelbine<br>* Day 1 Vinorelbine 20mg/mq for a maximum of 4 cycles<br>* Other names: Navelbine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate | 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response rate | To assess the response rate after BeGEV in terms of overall response rate (ORR) =Complete Response (CR) plus Partial Response (PR)). | 3 months | 
| mobilization potential of the combination | To evaluate the mobilization potential of BeGEV. | 3 months | 
| toxicity of the combination | To evaluate the toxicity of BeGEV in terms of haematological and extra-haematological side effects according to CTCAE definitions v 3.0. | 3 months | 
| Progression free survival (PFS), Overall Survival (OS). | Progression free survival and overall survival | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hodgkin, Lymphoma, refractory, relapsed