By InvitationPhase 2

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

Russia20 participantsStarted 2022-06-01

Plain-language 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.

Who can participate

Age range2 Years – 18 Years

SexALL

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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)

What they're measuring

Event free survival

Timeframe: 5-year

Trial details

NCT IDNCT06931613

SponsorSt. Petersburg State Pavlov Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-01

View on ClinicalTrials.gov More Relapsed or Refractory Hodgkin Lymphoma trials