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.
885 studies on the registry are indexed under Lymphoma, B-Cell; 286 are open to participants now.
This study's planned enrollment of 22 is below the median of 34 across 773 interventional studies indexed under Lymphoma, B-Cell.
Browse Lymphoma, B-Cell studies →St. Petersburg State Pavlov Medical University is the lead sponsor of 52 studies on the registry; 17 are open to participants now.
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Age from 0 years to 17 years 11 months
Exclusion Criteria:
Age >18
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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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Studies of the drug tested here: Nivolumab
St. Petersburg State Pavlov Medical University