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

Phase 2Enrolling By InvitationNCT06931613

St. Petersburg State Pavlov Medical University20 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

Eligibility

Sex: ALLMin age: 2 YearsMax age: 18 Years

Medical Language ↔ Plain English

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)

Locations (2)

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

Moscow, Russia

Pavlov University, RM Gorbacheva Research Institute

Saint Petersburg, Russia