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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Children; Nivolumab; Relapsed or Refractory Hodgkin Lymphoma; Autologous Haemopoietic Stem Cell Transplant
• Intervention / Treatment: Drug: Nivolumab

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • N. N. Blokhin Russian Cancer Research Center, Moscow, Russia
  • Saint-Petersburg, Russian Federation, 196022
    • Pavlov University, RM Gorbacheva Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The only ARM consists of nivolumab with or without bendamustine prior to auto-HSCT	Drug: Nivolumab; Nivolumab with or without bendamustine is administered to children prior to auto-HSCT; Other Names: bendamustine; autologous hematopoietic stem cell transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Event free survival	5-year

Collaborators and Investigators

• Sponsor: St. Petersburg State Pavlov Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: April 9, 2025
• First Submitted That Met QC Criteria: April 9, 2025
• First Posted (Actual): April 17, 2025

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: April 9, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma; Hodgkin Disease; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents, Alkylating; Alkylating Agents; Nivolumab; Bendamustine Hydrochloride
• Other Study ID Numbers: 34/19-н

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No