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

Last updated: December 13, 2022
Sponsor: National Research Center for Hematology, Russia
Overall Status: Active - Recruiting

Phase

2

Condition

Lymphoma

White Cell Disorders

Marginal Zone Lymphoma

Treatment

N/A

Clinical Study ID

NCT05660993
r/r cHL-2022
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 Design

Total Participants: 50
Study Start date:
August 19, 2019
Estimated Completion Date:
March 01, 2025

Connect with a study center

  • National Research Center for Hematology

    Moscow, 125167
    Russian Federation

    Active - Recruiting

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