Status:
UNKNOWN
Bendamustine, Gemcitabine and Vinorelbine (BeGEV) as Induction Therapy in Relapsed/Refractory Hodgkin's Lymphoma Patients
Lead Sponsor:
Armando Santoro, MD
Conditions:
Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 Transplant...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2016
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT01884441
Start Date
July 1 2011
End Date
July 1 2016
Last Update
January 29 2014
Active Locations (1)
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1
Istituto Clinico Humanitas
Rozzano, MI, Italy, 20089