Autologous Haemopoietic Stem Cell Transplant, Children, Nivolumab, Relapsed or Refractory Hodgkin Lymphoma
Conditions
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.
Interventions
DRUGNivolumab
Nivolumab with or without bendamustine is administered to children prior to auto-HSCT
Sponsors
St. Petersburg State Pavlov Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event free survival | 5-year |
Countries
Russia
Outcome results
None listed