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

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

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Brief summary

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

Study ID Nivo-DHAP-cHL-1 NCT04091490
Fase Phase 2
Enrollment 40
Study type Interventional
Has expanded access -

Locations

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

Design info

N/A Single Group Assignment Treatment None (Open Label)

Drug

  • Drug: Nivolumab

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

Condition

  • Hodgkin Lymphoma

Eligibility

Criteria

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
  • Gender: all
  • Age: 18 - 65
  • Healthy volunteers: no
  • Therapy type: -
  • Therapy Specification: -

Contact information

Local contact information

Overall contact

  • Lastname overall: Vladislav Sarzhevskiy, PhD
  • Role: Principal Investigator
  • Affiliation: National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation
  • NordicNect: No
Verification date 2023-09-01
Study first submitted 2019-09-13
Study first posted 2019-09-16
Last update submitted 2023-09-20
Last update posted 2023-09-21

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