A Phase 1/2 interventional study of Nivolumab in Primary Mediastinal (Thymic) Large B-cell Lymphoma, Children and Nivolumab, sponsored by St. Petersburg State Pavlov Medical University. Enrolling by invitation at 2 sites in Russian Federation. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2025-03-11.
Sponsored by St. Petersburg State Pavlov Medical University · Phase 1/2, Interventional, and Treatment
Addition of nivolumab (immune checkpoint inhibitor) to standard chemotherapy (DA-EPOCH-R) may improve outcome in children with primary mediastinal large B-cell lymphoma
A total of 6 blocks of Nivolumab+DA-EPOCH-R are planned for all patients regardless of stage and other risk factors. Nivolumab 40 mg (Day 2), Rituximab 375 mg/m2 (Day 1) and Prednisolone 60 mg/m2 (Days 1-5) are administered at constant unchangeable doses. Other drugs are administered at starting doses (Etoposide 50 mg/m2 (Days 1-4), Doxorubicin 10 mg/m2 (Days 1-4), Vincristine 0,4 mg/m2 (Days 1-4) and Cyclophosphamide 750 mg/m2 (Day 5). These starting doses are adjusted further according to standard principles of DA-EPOCH-R.
Age from 0 years to 17 years 11 months
Exclusion Criteria:
Age >18
Children with PMLBL will receive standard chemotherapy (dose-adjusted EPOCH-R) combined with nivolumab 40 mg on Day 2
Drug: Nivolumab
Nivolumab 40 mg on Day 2 is added to dose-adjusted EPOCH-R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab; DA-EPOCH-R).Standard guidelines for conducting the DA-EPOCH-R protocol will be used.
Also known as: Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Prednisolone, Rituximab
Event free survival
Kaplan-Meyer estimate
Time frame: 5 year
Overall survival
Kaplan-Meyer estimate
Time frame: 5 year
Progression free survival
Kaplan-Meyer estimate
Time frame: 5 year
Plan to share: No
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St. Petersburg State Pavlov Medical University