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

Phase 2

• Conditions: Relapsed or Refractory Hodgkin Lymphoma; Children; Nivolumab; Autologous Haemopoietic Stem Cell Transplant
• Interventions: Drug: Nivolumab

• Registration Number: NCT06931613
• Lead Sponsor: St. Petersburg State Pavlov Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-01
• Status Verified: 2025-04
• Study First Submitted: 2025-04-09
• Study First Submitted QC: 2025-04-09
• Last Update Submitted: 2025-04-09
• Study First Posted: 2025-04-17
• Last Update Posted: 2025-04-17
• Primary Completion: 2026-06-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The only ARM consists of nivolumab with or without bendamustine prior to auto-HSCT	Nivolumab	-

Primary Outcome Measures

Name	Time	Method
Event free survival	5-year

Trial Locations

Locations (2)

N. N. Blokhin Russian Cancer Research Center, Moscow, Russia; 🇷🇺 Moscow, Russian Federation

Pavlov University, RM Gorbacheva Research Institute; 🇷🇺 Saint-Petersburg, Russian Federation