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

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ClinicalTrials.gov Identifier: NCT04091490
Recruitment Status : Not yet recruiting
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia

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

Condition or disease Intervention/treatment Phase
Hodgkin Lymphoma Drug: Nivolumab Phase 2

Detailed 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dexamethasone, Cytarabine, Cisplatin and Nivolumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (Nivo-DHAP-cHL)
Estimated Study Start Date : January 9, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Patients with relapsed/refractory Hodgkin's lymphoma
A clinical study of safety and efficacy of treatment with Nivolumab and DHAP in patients with relapsed/refractory Hodgkin's lymphoma
Drug: Nivolumab
Combination of 2 cycles of Nivolumab as a monotherapy with 4 cycles of high-dose chemotherapy (DHAP chemoregimen) with Nivolumab
Other Name: Opdivo




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091490


Contacts
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Contact: Vladislav Sarzhevskiy, PhD +74956037217 vladsar100@gmail.com
Contact: Nikita Mochkin, PhD +74956037217 nickmed@yandex.ru

Locations
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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, 105203
Sponsors and Collaborators
State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
Investigators
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Principal Investigator: Vladislav Sarzhevskiy, PhD National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation

Publications of Results:
Other Publications:
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Responsible Party: State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
ClinicalTrials.gov Identifier: NCT04091490     History of Changes
Other Study ID Numbers: Nivo-DHAP-cHL-1
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents