Multicenter Study of Safety and Efficacy of PET-adapted Treatment With Nivolumab, Bendamustine, Gemcitabine, Vinorelbine (Nivo-BeGEV) in Patients With Relapsed/Refractory Hodgkin Lymphoma

December 13, 2022 updated by: Elena N.Parovichnikova, National Research Center for Hematology, Russia
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 125167
        • Recruiting
        • National Research Center for Hematology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Main arm

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.
Drug: Nivolumab

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months
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
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: 24 months
24 months
1. Duration of Response (DOR)
Time Frame: 24 months
24 months
Progression-Free Survival (PFS)
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Research Center for Hematology, Russia

Investigators

  • Study Director: Elena Parovichnikova,, MD,PhD, Nathional Medical Research Center for Hematology Moscow Russia 125167

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2019

Primary Completion (Anticipated)

March 1, 2025

Study Completion (Anticipated)

March 1, 2025

Study Registration Dates

First Submitted

December 13, 2022

First Submitted That Met QC Criteria

December 13, 2022

First Posted (Actual)

December 21, 2022

Study Record Updates

Last Update Posted (Actual)

December 21, 2022

Last Update Submitted That Met QC Criteria

December 13, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • r/r cHL-2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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