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

Sponsor
State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia (Other)
Overall Status
Recruiting
CT.gov ID
NCT04091490
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
34.4
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
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)
Actual Study Start Date :
Feb 19, 2020
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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 Names:
  • Opdivo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall Response Rate (ORR) of Nivolumab and DHAP in patients with relapsed/refractory Hodgkin's lymphoma [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 [up to 6 months]

      Toxicity parameters based on NCI CTCAE 4.03 grades

    2. Progression-Free Survival [up to 12 months]

    3. Overall Survival [up to 12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    • Principal Investigator: Vladislav Sarzhevskiy, PhD, National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
    ClinicalTrials.gov Identifier:
    NCT04091490
    Other Study ID Numbers:
    • Nivo-DHAP-cHL-1
    First Posted:
    Sep 16, 2019
    Last Update Posted:
    Oct 30, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lymphoma
    Hodgkin Disease
    Nivolumab

    Study Results

    No Results Posted as of Oct 30, 2020