Status:
ENROLLING_BY_INVITATION
Autologous Hematopoietic Stem Cell Transplantation in Pediatric Relapsed or Refractory Hodgkin Lymphoma After Nivolumab Treatment
Lead Sponsor:
St. Petersburg State Pavlov Medical University
Conditions:
Relapsed or Refractory Hodgkin Lymphoma
Children
Eligibility:
All Genders
2-18 years
Phase:
PHASE2
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 additio...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06931613
Start Date
June 1 2022
End Date
June 1 2027
Last Update
April 17 2025
Active Locations (2)
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1
N. N. Blokhin Russian Cancer Research Center, Moscow, Russia
Moscow, Russia
2
Pavlov University, RM Gorbacheva Research Institute
Saint Petersburg, Russia, 196022