Combination of Nivolumab and DHAP in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (Nivo-DHAP)

Last updated: September 20, 2023
Sponsor: State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
Overall Status: Completed

Phase

2

Condition

Lymphoma

Hematologic Cancer

Marginal Zone Lymphoma

Treatment

Nivolumab

Clinical Study ID

NCT04091490
Nivo-DHAP-cHL-1
  • Ages 18-65
  • All Genders

Study Summary

A clinical study of safety and efficacy of treatment with Nivolumab and DHAP in patients with relapsed/refractory Hodgkin's lymphoma

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed informed consent
  • Histologically confirmed Hodgkin's lymphoma
  • Measurable disease (at least one lesion that can be accurately measured in at leasttwo dimensions with spiral CT scan, min > 15 mm in the longest diameter or > 10 mm inthe short axis)
  • World Health Organization (WHO) performance status < 2
  • Relapsed or refractory to at least one prior treatment line
  • No prior therapy with DHAP or Nivolumab
  • No severe concurrent illness

Exclusion

Exclusion Criteria:

  • History of HIV
  • Active Hepatitis B or Hepatitis C infection
  • Uncontrolled infection (requiring intravenous treatment) at the time of enrollment
  • Pregnancy or breastfeeding
  • Somatic or psychiatric disorder making the patient unable to sign informed consent
  • Active or prior documented autoimmune disease requiring systemic treatment
  • No receiving a live vaccine within 30 days prior to first dose of nivolumab
  • History of non-infectious pneumonitis that required steroids
  • Other malignancy

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Nivolumab
Phase: 2
Study Start date:
February 19, 2020
Estimated Completion Date:
December 31, 2022

Study Description

A Clinical Study of Safety and Efficacy of Treatment With Nivolumab and Dexamethasone, Cytarabine and Cisplatin (DHAP) in Patients With Relapsed/Refractory Hodgkin's Lymphoma

Connect with a study center

  • The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation

    Moscow, 105203
    Russian Federation

    Site Not Available

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