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

NCT ID: NCT06931613

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2027-06-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Nivolumab

Intervention Type: DRUG

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

Interventions

Nivolumab

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

Intervention Type: DRUG

Other Intervention Names

bendamustine; autologous hematopoietic stem cell transplantation

Eligibility Criteria

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)

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Petersburg State Pavlov Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ivan S Moiseev

Professor, RM Gorbacheva Research Institute at First Pavlov State Medical University of St. Petersburg Russia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Moscow, , Russia

Pavlov University, RM Gorbacheva Research Institute

Saint Petersburg, , Russia

Countries

Russia

Other Identifiers

34/19-н

Identifier Type: -

Identifier Source: org_study_id