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Enrolling by invitation NCT06931613

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

Phase II Interventional Relapsed or Refractory Hodgkin Lymphoma Children Nivolumab Autologous Haemopoietic Stem Cell Transplant

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nivolumab.
Who it may be relevant to
Registry conditions: Relapsed or Refractory Hodgkin Lymphoma, Children, Nivolumab, Autologous Haemopoietic Stem Cell Transplant. Basic parameters: 2 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Event free survival [Time frame: 5-year]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Russia · 2 centers
  • N. N. Blokhin Russian Cancer Research Center, Moscow, Russia — Moscow
  • Pavlov University, RM Gorbacheva Research Institute — Saint Petersburg

Identifiers

NCT: NCT06931613 · 34/19-н

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗