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

NCT04091490 | Completed Phase 2

• 1 other identifier: Nivo-DHAP-cHL-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

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

  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

  up to 6 months

Secondary Outcomes (3)

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

  up to 6 months

• Progression-Free Survival

  up to 12 months

• Overall Survival

  up to 12 months

Study Arms (1)

Patients with relapsed/refractory Hodgkin's lymphoma

EXPERIMENTAL

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

Drug: Nivolumab

Interventions

Nivolumab DRUG

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

Also known as: Opdivo

Patients with relapsed/refractory Hodgkin's lymphoma

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (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, 105203, Russia

Location

Related Publications (3)

• Sasse S, Alram M, Muller H, Smardova L, Metzner B, Doehner H, Fischer T, Niederwieser DW, Schmitz N, Schafer-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.

  PMID: 26693800 BACKGROUND

• 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.

  PMID: 29584546 BACKGROUND

• Josting A, Rudolph C, Reiser M, Mapara M, Sieber M, Kirchner HH, Dorken 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. doi: 10.1093/annonc/mdf221.

  PMID: 12377653 RESULT

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Vladislav Sarzhevskiy, PhD

  National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 16, 2019
• Study Start: February 19, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)