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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
0 - 18 years
Sex
ALL
Healthy Volunteers
No
Dmitry Rogachev National Research Center
Moscow, Russia
Pavlov University, RM Gorbacheva Research Institute
Saint Petersburg, Russia
Start Date
September 1, 2024
Primary Completion Date
September 1, 2029
Completion Date
September 1, 2031
Last Updated
March 11, 2025
22
ESTIMATED participants
Nivolumab
DRUG
Lead Sponsor
St. Petersburg State Pavlov Medical University
NCT07360600
NCT07468006
Data Source & Attribution
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