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Completed

NCT Number: NCT04091490

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

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

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Key information

Conditions

Hodgkin Lymphoma Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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, Russia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent
  • Histologically confirmed Hodgkin's lymphoma
  • Measurable disease (at least one lesion that can be accurately measured in at least two dimensions with spiral CT scan, min > 15 mm in the longest diameter or > 10 mm in the 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 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

Treatment and study plan

Nivolumab

Drug

Combination of 2 cycles of Nivolumab as a monotherapy with 4 cycles of high-dose chemotherapy (DHAP chemoregimen) with Nivolumab

Other names: Opdivo

Primary outcomes

  1. Overall Response Rate (ORR) of Nivolumab and DHAP in patients with relapsed/refractory Hodgkin's lymphoma

    Time frame: up to 6 months

    Overall response rate (ORR), defined as proportion of patients with complete response (CR) or partial response (PR) in measurable lesions as defined by Lugano classification and duration of response

Secondary outcomes

  1. Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03

    Time frame: up to 6 months

    Toxicity parameters based on NCI CTCAE 4.03 grades

  2. Progression-Free Survival

    Time frame: up to 12 months

  3. Overall Survival

    Time frame: up to 12 months

Sponsors and collaborators

Lead sponsor

State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia

Other

Registry information

Official study title

Dexamethasone, Cytarabine, Cisplatin and Nivolumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (Nivo-DHAP-cHL)

Acronym: Nivo-DHAP

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 16, 2019
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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