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

March 6, 2025 updated by: Ivan S Moiseev, St. Petersburg State Pavlov Medical University
Addition of nivolumab (immune checkpoint inhibitor) to standard chemotherapy (DA-EPOCH-R) may improve outcome in children with primary mediastinal large B-cell lymphoma

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

22

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation
        • Dmitry Rogachev National Research Center
      • Saint-Petersburg, Russian Federation, 196022
        • Pavlov University, RM Gorbacheva Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: The only ARM consists of nivolumab combined with DA-EPOCH-R protocol
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.
Other Names:
  • Rituximab
  • Prednisolone
  • Cyclophosphamide
  • Doxorubicin
  • Etoposide
  • Vincristine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event free survival
Time Frame: 5 year
Kaplan-Meyer estimate
5 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 year
Kaplan-Meyer estimate
5 year
Progression free survival
Time Frame: 5 year
Kaplan-Meyer estimate
5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Petersburg State Pavlov Medical University

Investigators

  • Principal Investigator: Natalya Myakova, Dmitry Rogachev National Research Center
  • Principal Investigator: Ludmila Zubarovskaya, Pavlov University, R.M. Gorbacheva Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2031

Study Registration Dates

First Submitted

February 21, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 6, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 290

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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