Nivolumab and DA-EPOCH-R in Pediatric Primary Mediastinal (Thymic) Large B-cell Lymphoma

Phase 1

• Conditions: Primary Mediastinal (Thymic) Large B-cell Lymphoma; Children; Nivolumab
• Interventions: Drug: Nivolumab

• Registration Number: NCT06871007
• Lead Sponsor: St. Petersburg State Pavlov Medical University

Brief Summary

Addition of nivolumab (immune checkpoint inhibitor) to standard chemotherapy (DA-EPOCH-R) may improve outcome in children with primary mediastinal large B-cell lymphoma

Detailed Description

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.

Study Timeline

• Study Start: 2024-09-01
• Study First Submitted: 2025-02-21
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-06
• Last Update Submitted: 2025-03-06
• Study First Posted: 2025-03-11
• Last Update Posted: 2025-03-11
• Primary Completion: 2029-09-01
• Study Completion: 2031-09-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Age from 0 years to 17 years 11 months

  • Established on the basis of histological and immunohistochemical studies, the diagnosis of PMLBL (the presence of programmed death-ligand on tumor cells is not necessary)
  • Lack of specific therapy for lymphoma
  • Signed informed consent

Exclusion Criteria

• Age >18

  • History of specific therapy for lymphomas.
  • Drug intolerance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The only ARM consists of nivolumab combined with DA-EPOCH-R protocol	Nivolumab	Children with PMLBL will receive standard chemotherapy (dose-adjusted EPOCH-R) combined with nivolumab 40 mg on Day 2

Primary Outcome Measures

Name	Time	Method
Event free survival	5 year	Kaplan-Meyer estimate

Secondary Outcome Measures

Name	Time	Method
Overall survival	5 year	Kaplan-Meyer estimate
Progression free survival	5 year	Kaplan-Meyer estimate

Trial Locations

Locations (2)

Dmitry Rogachev National Research Center; 🇷🇺 Moscow, Russian Federation

Pavlov University, RM Gorbacheva Research Institute; 🇷🇺 Saint-Petersburg, Russian Federation