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

Armando Santoro, MD

Status and phase: Unknown; Phase 2

Conditions: Hodgkin's Lymphoma

Treatments: Drug: Vinorelbine; Drug: Gemcitabine; Drug: Bendamustine

Study type: Interventional

Funder types: Other

Identifiers

NCT01884441

2010-022169-91 (EudraCT Number)

ONC-2010-002

Details and patient eligibility

About

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

Full 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).

Enrollment: 59 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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59 participants in 1 patient group

BeGEV

Experimental group

Description:

Bendamustine, Gemcitabine and Vinorelbine (BeGEV)

Treatment:

Drug: Bendamustine

Drug: Gemcitabine

Drug: Vinorelbine