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

Overview

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

Full Title of Study: “Dexamethasone, Cytarabine, Cisplatin and Nivolumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (Nivo-DHAP-cHL)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2021

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

Interventions

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

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • Progression-Free Survival
    • Time Frame: up to 12 months
  • Overall Survival
    • Time Frame: up to 12 months

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Vladislav Sarzhevskiy, PhD, Principal Investigator, National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation
  • Overall Contact(s)
    • Vladislav Sarzhevskiy, PhD, +74956037217, vladsar100@gmail.com

References

Sasse S, Alram M, Müller H, Smardová L, Metzner B, Doehner H, Fischer T, Niederwieser DW, Schmitz N, Schäfer-Eckart K, Raemaekers JM, Schmalz O, Tresckow BV, Engert A, Borchmann P. Prognostic relevance of DHAP dose-density in relapsed Hodgkin lymphoma: an analysis of the German Hodgkin-Study Group. Leuk Lymphoma. 2016 May;57(5):1067-73. doi: 10.3109/10428194.2015.1083561. Epub 2015 Dec 23.

Armand P, Engert A, Younes A, Fanale M, Santoro A, Zinzani PL, Timmerman JM, Collins GP, Ramchandren R, Cohen JB, De Boer JP, Kuruvilla J, Savage KJ, Trneny M, Shipp MA, Kato K, Sumbul A, Farsaci B, Ansell SM. Nivolumab for Relapsed/Refractory Classic Hodgkin Lymphoma After Failure of Autologous Hematopoietic Cell Transplantation: Extended Follow-Up of the Multicohort Single-Arm Phase II CheckMate 205 Trial. J Clin Oncol. 2018 May 10;36(14):1428-1439. doi: 10.1200/JCO.2017.76.0793. Epub 2018 Mar 27. Erratum in: J Clin Oncol. 2018 Sep 10;36(26):2748.

Citations Reporting on Results

Josting A, Rudolph C, Reiser M, Mapara M, Sieber M, Kirchner HH, Dörken B, Hossfeld DK, Diehl V, Engert A; Participating Centers. Time-intensified dexamethasone/cisplatin/cytarabine: an effective salvage therapy with low toxicity in patients with relapsed and refractory Hodgkin's disease. Ann Oncol. 2002 Oct;13(10):1628-35.

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