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

Phase 2

• Conditions: Hodgkin's Lymphoma
• Interventions: Drug: Bendamustine; Drug: Gemcitabine; Drug: Vinorelbine

• Registration Number: NCT01884441
• Lead Sponsor: Armando Santoro, MD

Brief 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).

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2013-05-27
• Study First Submitted QC: 2013-06-20
• Study First Posted: 2013-06-24
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-28
• Last Update Posted: 2014-01-29
• Primary Completion: 2014-07
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BeGEV	Bendamustine	Bendamustine, Gemcitabine and Vinorelbine (BeGEV)
BeGEV	Gemcitabine	Bendamustine, Gemcitabine and Vinorelbine (BeGEV)
BeGEV	Vinorelbine	Bendamustine, Gemcitabine and Vinorelbine (BeGEV)

Primary Outcome Measures

Name	Time	Method
Response Rate	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Istituto Clinico Humanitas; 🇮🇹 Rozzano, MI, Italy