Back to resultsBendamustine, Gemcitabine and Vinorelbine (BeGEV) as Induction Therapy in Relapsed/Refractory Hodgkin's Lymphoma Patients
Primary Purpose
Hodgkin's Lymphoma
Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Bendamustine
Gemcitabine
Vinorelbine
Sponsored by
About this trial
This is an interventional treatment trial for Hodgkin's Lymphoma focused on measuring Hodgkin, Lymphoma, refractory, relapsed
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
Sites / Locations
- Istituto Clinico HumanitasRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BeGEV
Arm Description
Bendamustine, Gemcitabine and Vinorelbine (BeGEV)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
overall response rate
To assess the response rate after BeGEV in terms of overall response rate (ORR) =Complete Response (CR) plus Partial Response (PR)).
mobilization potential of the combination
To evaluate the mobilization potential of BeGEV.
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.
Progression free survival (PFS), Overall Survival (OS).
Progression free survival and overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01884441
Brief Title
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
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
July 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Armando Santoro, MD
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin's Lymphoma
Keywords
Hodgkin, Lymphoma, refractory, relapsed
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BeGEV
Arm Type
Experimental
Arm Description
Bendamustine, Gemcitabine and Vinorelbine (BeGEV)
Intervention Type
Drug
Intervention Name(s)
Bendamustine
Other Intervention Name(s)
Ribomustin
Intervention Description
Schedule:
Day 2: Bendamustine 90mg/mq Day 3: Bendamustine 90mg/mq for a maximum of 4 cycles
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
Day 1: Gemcitabine 800mg/mq, Day 4: Gemcitabine 800mg/mq for a maximum of 4 cycles
Intervention Type
Drug
Intervention Name(s)
Vinorelbine
Other Intervention Name(s)
Navelbine
Intervention Description
Day 1 Vinorelbine 20mg/mq for a maximum of 4 cycles
Primary Outcome Measure Information:
Title
Response Rate
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
overall response rate
Description
To assess the response rate after BeGEV in terms of overall response rate (ORR) =Complete Response (CR) plus Partial Response (PR)).
Time Frame
3 months
Title
mobilization potential of the combination
Description
To evaluate the mobilization potential of BeGEV.
Time Frame
3 months
Title
toxicity of the combination
Description
To evaluate the toxicity of BeGEV in terms of haematological and extra-haematological side effects according to CTCAE definitions v 3.0.
Time Frame
3 months
Title
Progression free survival (PFS), Overall Survival (OS).
Description
Progression free survival and overall survival
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Armando Santoro, MD
Phone
+39 (0)2 8224
Ext
4080
Email
armando.santoro@humanitas.it
First Name & Middle Initial & Last Name or Official Title & Degree
Rita Mazza, MD
Phone
+39 (0)2 8224
Ext
4780
Email
rita.mazza@humanitas.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armando Santoro, MD
Organizational Affiliation
Istituto Clinico Humanitas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
MI
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Armando Santoro, MD
Phone
+39 (0)2 8224
Ext
4080
Email
armando.santoro@humanitas.it
First Name & Middle Initial & Last Name & Degree
Rita Mazza, MD
Phone
+39 (0)2 8224
Ext
4780
Email
rita.mazza@humanitas.it
First Name & Middle Initial & Last Name & Degree
Armando Santoro, MD
First Name & Middle Initial & Last Name & Degree
Rita Mazza, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
31935284
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.
Results Reference
derived
PubMed Identifier
27382096
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.
Results Reference
derived
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Bendamustine, Gemcitabine and Vinorelbine (BeGEV) as Induction Therapy in Relapsed/Refractory Hodgkin's Lymphoma Patients
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