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
18 Years
N/A
Both
Hodgkin's Lymphoma
Trial Information
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
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).
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response Rate
Outcome Description:
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.
Outcome Time Frame:
3 months
Safety Issue:
No
Principal Investigator
Armando Santoro, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Istituto Clinico Humanitas
Authority:
Italy: Ministry of Health
Study ID:
ONC-2010-002
NCT ID:
NCT01884441
Start Date:
July 2011
Completion Date:
July 2016
Related Keywords:
- Hodgkin's Lymphoma
- Hodgkin
- Lymphoma
- refractory
- relapsed
- Hodgkin Disease
- Lymphoma
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