Back to resultsMulticenter Study of Safety and Efficacy of PET-adapted Treatment With Nivolumab, Bendamustine, Gemcitabine, Vinorelbine (Nivo-BeGEV) in Patients With Relapsed/Refractory Hodgkin Lymphoma
Primary Purpose
Hodgkin Lymphoma
Status
Recruiting
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Nivolumab
Sponsored by
About this trial
This is an interventional treatment trial for Hodgkin Lymphoma focused on measuring PET-adapted Treatment, Relapsed/Refractory Hodgkin Lymphoma, Nivolumab, BeGEV
Eligibility Criteria
Inclusion Criteria: Diagnosis: Histologically confirmed Hodgkins lymphoma Relapsed or refractory disease after the first line of treatment Age 18-70 years old Ejection fraction greater than 50% ECOG 0-2 status Signed informed consent No severe concurrent illness Exclusion Criteria: Uncontrolled bacterial or fungal infection at the time of enrollment Requirement for vasopressor support at the time of enrollment Severe organ failure: creatinine more than 2 norms; ALT, AST more than 5 norms; bilirubin more than 1.5 norms Karnofsky index <30% Pregnancy Somatic or psychiatric disorder making the patient unable to sign an informed consent Active or prior documented autoimmune disease requiring systemic treatment.
Sites / Locations
- National Research Center for HematologyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Main arm
Arm Description
Patients will receive for a maximum of 4 cycles of nivolumab 3 mg/kg on day 0 BeGEV , with subsequent assessment of response by PET-CT. Patients with CR after 2 cycles Nivo-BeGEV will proceed to ASCT. Patients with <CR after 2 cycles of a combination Nivo-BeGEV, with subsequent PET-CT assessment, will receive an additional 2 cycles Nivo-BeGEV. Patients with CR after 4 cycles Nivo-BeGEV will proceed to ASCT.
Outcomes
Primary Outcome Measures
1. Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03 Toxicity parameters based on NCI CTCAE 4.03 grades
2. Overall Response Rate (ORR) Overall response rate (ORR), defined as the proportion of patients with complete response (CR) or partial response (PR) in measurable lesions as defined by LYRIC and Lugano 2014 criteria
Secondary Outcome Measures
1. Duration of Response (DOR)
Overall Survival (OS)
Progression-Free Survival (PFS)
Full Information
NCT ID
NCT05660993
First Posted
December 13, 2022
Last Updated
December 13, 2022
Sponsor
National Research Center for Hematology, Russia
1. Study Identification
Unique Protocol Identification Number
NCT05660993
Brief Title
Multicenter Study of Safety and Efficacy of PET-adapted Treatment With Nivolumab, Bendamustine, Gemcitabine, Vinorelbine (Nivo-BeGEV) in Patients With Relapsed/Refractory Hodgkin Lymphoma
Official Title
Multicenter Study of Safety and Efficacy of PET-adapted Treatment With Nivolumab, Bendamustine, Gemcitabine, Vinorelbine (Nivo-BeGEV) in Patients With Relapsed/Refractory Hodgkin Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 19, 2019 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Research Center for Hematology, Russia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Nivolumab is an anti-PD-1 antibody highly effective in patients with relapsed/refractory classical Hodgkin lymphoma. A PET-adapted regimen of nivolumab combined with salvage therapy was shown to induce high response rates and favorable progression-free survival as a bridge to autologous stem cell transplantation, allowing to omit salvage chemotherapy in a substantial proportion of r\r cHL patients. This study evaluates the safety and efficacy of PET-adapted treatment of nivolumab at the 3 mg/kg in combination with Bendamustine, Gemcitabine, Vinorelbine (Nivo-BeGEV) in patients with relapsed/refractory Hodgkin Lymphoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma
Keywords
PET-adapted Treatment, Relapsed/Refractory Hodgkin Lymphoma, Nivolumab, BeGEV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Main arm
Arm Type
Experimental
Arm Description
Patients will receive for a maximum of 4 cycles of nivolumab 3 mg/kg on day 0 BeGEV , with subsequent assessment of response by PET-CT. Patients with CR after 2 cycles Nivo-BeGEV will proceed to ASCT.
Patients with <CR after 2 cycles of a combination Nivo-BeGEV, with subsequent PET-CT assessment, will receive an additional 2 cycles Nivo-BeGEV. Patients with CR after 4 cycles Nivo-BeGEV will proceed to ASCT.
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Intervention Description
Drug: Nivolumab Schedule: Nivolumab 3 mg/kg on day 0 of the Nivo-BeGEV or a maximum of 4 cycles Drug: Bendamustine
Schedule:
Day 2: Bendamustine 90mg/mq Day 3: Bendamustine 90mg/mq for a maximum of 4 cycles Other Name: Ribomustin
Drug: Gemcitabine Day 1: Gemcitabine 800mg/mq, Day 4: Gemcitabine 800mg/mq for a maximum of 4 cycles Other Name: Gemzar
Drug: Vinorelbine Day 1 Vinorelbine 20mg/mq for a maximum of 4 cycles Other Name: Navelbine
Primary Outcome Measure Information:
Title
1. Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03 Toxicity parameters based on NCI CTCAE 4.03 grades
Time Frame
12 months
Title
2. Overall Response Rate (ORR) Overall response rate (ORR), defined as the proportion of patients with complete response (CR) or partial response (PR) in measurable lesions as defined by LYRIC and Lugano 2014 criteria
Time Frame
12 months
Secondary Outcome Measure Information:
Title
1. Duration of Response (DOR)
Time Frame
24 months
Title
Overall Survival (OS)
Time Frame
24 months
Title
Progression-Free Survival (PFS)
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis: Histologically confirmed Hodgkins lymphoma
Relapsed or refractory disease after the first line of treatment
Age 18-70 years old
Ejection fraction greater than 50%
ECOG 0-2 status
Signed informed consent
No severe concurrent illness
Exclusion Criteria:
Uncontrolled bacterial or fungal infection at the time of enrollment
Requirement for vasopressor support at the time of enrollment
Severe organ failure: creatinine more than 2 norms; ALT, AST more than 5 norms; bilirubin more than 1.5 norms
Karnofsky index <30%
Pregnancy
Somatic or psychiatric disorder making the patient unable to sign an informed consent
Active or prior documented autoimmune disease requiring systemic treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yana Mangasarova, MD
Phone
+74956122361
Email
v.k.jana@mail.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Eugene Zvonkov, MD,PhD
Phone
+7 (495) 612-13-31
Email
dr.zvonkov@mail.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Parovichnikova,, MD,PhD
Organizational Affiliation
Nathional Medical Research Center for Hematology Moscow Russia 125167
Official's Role
Study Director
Facility Information:
Facility Name
National Research Center for Hematology
City
Moscow
ZIP/Postal Code
125167
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena Parovichnikova
Phone
7 (495) 612-23-61
Email
director@blood.ru
12. IPD Sharing Statement
Learn more about this trial
Multicenter Study of Safety and Efficacy of PET-adapted Treatment With Nivolumab, Bendamustine, Gemcitabine, Vinorelbine (Nivo-BeGEV) in Patients With Relapsed/Refractory Hodgkin Lymphoma
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