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

Hodgkin's Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01884441
• Other study ID #: ONC-2010-002
• Secondary ID: 2010-022169-91
• Status: Recruiting
• Phase: Phase 2
• First received: May 27, 2013
• Last updated: January 28, 2014
• Start date: July 2011
• Est. completion date: July 2016

Study information

• Verified date: January 2014
• Source: Istituto Clinico Humanitas
• Contact: Armando Santoro, MD
• Phone: +39 (0)2 8224
• Email: armando.santoro[@]humanitas.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 59
• Est. completion date: July 2016
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Lymphoma
• Lymphoma

Intervention

Drug:
• Bendamustine
Schedule: Day 2: Bendamustine 90mg/mq Day 3: Bendamustine 90mg/mq for a maximum of 4 cycles
• Gemcitabine
Day 1: Gemcitabine 800mg/mq, Day 4: Gemcitabine 800mg/mq for a maximum of 4 cycles
• Vinorelbine
Day 1 Vinorelbine 20mg/mq for a maximum of 4 cycles

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Rozzano	MI

Sponsors (1)

Lead Sponsor	Collaborator
Armando Santoro, MD

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	mobilization potential of the combination	To evaluate the mobilization potential of BeGEV.	3 months	No
Secondary	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	Yes
Secondary	Progression free survival (PFS), Overall Survival (OS).	Progression free survival and overall survival	2 years	No