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

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.

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Key information

Conditions

Relapsed or Refractory Hodgkin Lymphoma Autologous Haemopoietic Stem Cell Transplant Children Disease Attributes Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Nivolumab Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 -

Exclusion criteria

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)

Treatment and study plan

Nivolumab

Drug

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

Other names: bendamustine, autologous hematopoietic stem cell transplantation

Primary outcomes

Event free survival

Time frame: 5-year

Sponsors and collaborators

Lead sponsor

St. Petersburg State Pavlov Medical University

Other

Registry information

Official study title

Autologous Hematopoietic Stem Cell Transplantation in Pediatric Relapsed or Refractory Hodgkin Lymphoma After Nivolumab Treatment With or Without Bendamustine

Important dates

Study start: 2022
Primary completion: 2026
Study completion: 2027
First posted: Apr 17, 2025
Registry last updated: Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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