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

NCT06871007 | Enrolling By Invitation Phase 1

• 1 other identifier: 290
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

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

Conditions

Primary Mediastinal (Thymic) Large B-cell Lymphoma; Children; Nivolumab

Outcome Measures

Primary Outcomes (1)

• Event free survival

  Kaplan-Meyer estimate

  5 year

Secondary Outcomes (2)

• Overall survival

  5 year

• Progression free survival

  5 year

Study Arms (1)

The only ARM consists of nivolumab combined with DA-EPOCH-R protocol

OTHER

Children with PMLBL will receive standard chemotherapy (dose-adjusted EPOCH-R) combined with nivolumab 40 mg on Day 2

Drug: Nivolumab

Interventions

Nivolumab DRUG

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

The only ARM consists of nivolumab combined with DA-EPOCH-R protocol

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Age \>18
• History of specific therapy for lymphomas.
• Drug intolerance

Sponsors & Collaborators

• St. Petersburg State Pavlov Medical University: lead

Study Sites (2)

Dmitry Rogachev National Research Center

Moscow, Russia

Location

Pavlov University, RM Gorbacheva Research Institute

Saint Petersburg, 196022, Russia

Location

MeSH Terms

Interventions

Nivolumab; Etoposide; Doxorubicin; Vincristine; Cyclophosphamide; Prednisolone; Rituximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Daunorubicin; Anthracyclines; Naphthacenes; Aminoglycosides; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Antibodies, Monoclonal, Murine-Derived

Study Officials

• Natalya Myakova

  Dmitry Rogachev National Research Center

  PRINCIPAL INVESTIGATOR

• Ludmila Zubarovskaya

  Pavlov University, R.M. Gorbacheva Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-director of RM Gorbacheva Research Institute

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: March 11, 2025
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2031
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2)