Clinical trial NCT01884441: Bendamustine, Gemcitabine and Vinorelbine (BeGEV) as Induction Therapy in Relapsed/Refractory Hodgkin's Lymphoma Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hodgkin's Lymphoma
Keywords: Hodgkin
Lymphoma
refractory
relapsed
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2013-06-24
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Response Rate
timeFrame: 3 months
Secondary outcomes:
measure: overall response rate
timeFrame: 3 months
measure: mobilization potential of the combination
timeFrame: 3 months
measure: toxicity of the combination
timeFrame: 3 months
measure: Progression free survival (PFS), Overall Survival (OS).
timeFrame: 2 years
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: MI
Study officials:
affiliation: Istituto Clinico Humanitas
name: Armando Santoro, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Santoro A, Mazza R, Pulsoni A, Re A, Bonfichi M, Zilioli VR, Zanni M, Merli F, Anastasia A, Luminari S, Annechini G, Gotti M, Peli A, Liberati AM, Di Renzo N, Castagna L, Giordano L, Ricci F, Carlo-Stella C. Five-year results of the BEGEV salvage regimen in relapsed/refractory classical Hodgkin lymphoma. Blood Adv. 2020 Jan 14;4(1):136-140. doi: 10.1182/bloodadvances.2019000984.
citation: Santoro A, Mazza R, Pulsoni A, Re A, Bonfichi M, Zilioli VR, Salvi F, Merli F, Anastasia A, Luminari S, Annechini G, Gotti M, Peli A, Liberati AM, Di Renzo N, Castagna L, Giordano L, Carlo-Stella C. Bendamustine in Combination With Gemcitabine and Vinorelbine Is an Effective Regimen As Induction Chemotherapy Before Autologous Stem-Cell Transplantation for Relapsed or Refractory Hodgkin Lymphoma: Final Results of a Multicenter Phase II Study. J Clin Oncol. 2016 Sep 20;34(27):3293-9. doi: 10.1200/JCO.2016.66.4466. Epub 2016 Jul 5.