Autologous Hematopoietic Stem Cell Transplantation in Pediatric Relapsed or Refractory Hodgkin Lymphoma After Nivolumab Treatment

NCT06931613 | Enrolling By Invitation Phase 2

• 1 other identifier: 34/19-н
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

Children with relapsed or refractory Hodgkin lymphoma receive 3-6 cycles of nivolumab monotherapy. In case of achieving complete response (CR) auto-HSCT is performed. In the absence of CR, 3-6 additional cycles of nivolumab with bendamustine are administered. If complete or partial response is achieved, auto-HSCT is performed.

Conditions

Relapsed or Refractory Hodgkin Lymphoma; Children; Nivolumab; Autologous Haemopoietic Stem Cell Transplant

Outcome Measures

Primary Outcomes (1)

• Event free survival

  5-year

Study Arms (1)

The only ARM consists of nivolumab with or without bendamustine prior to auto-HSCT

EXPERIMENTAL

Drug: Nivolumab

Interventions

Nivolumab DRUG

Nivolumab with or without bendamustine is administered to children prior to auto-HSCT

Also known as: bendamustine, autologous hematopoietic stem cell transplantation

The only ARM consists of nivolumab with or without bendamustine prior to auto-HSCT

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of Hodgkin lymphoma established on the basis of histological and immunohistochemical studies
• Confirmation of relapsed of refractory Hodgkin lymphoma based on histological and immunohistochemical studies or based on imaging methods (PET/CT and/or CT).
• Number of previous lines of therapy \>2
• Karnofsky index ≥60%
• availability of signed informed consent -

You may not qualify if:

• Number of previous lines of therapy ≤ 2
• Karnofsky index \< 60
• Intolerance to drugs used in the study
• Presence of a second tumor
• Pregnancy or lactation
• Participation in another study within six months
• Presence of concomitant severe disease
• Presence of HIV and/or viral hepatitis (B or C)

Sponsors & Collaborators

• St. Petersburg State Pavlov Medical University: lead

Study Sites (2)

N. N. Blokhin Russian Cancer Research Center, Moscow, Russia

Moscow, Russia

Location

Pavlov University, RM Gorbacheva Research Institute

Saint Petersburg, 196022, Russia

Location

MeSH Terms

Conditions

Recurrence; Hodgkin Disease

Interventions

Nivolumab; Bendamustine Hydrochloride

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, RM Gorbacheva Research Institute at First Pavlov State Medical University of St. Petersburg Russia

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 17, 2025
• Study Start: June 1, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 17, 2025

Record last verified: 2025-04

Locations

RU (2)