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Enrolling by Invitation

NCT Number: NCT06871007

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

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

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Key information

Conditions

Primary Mediastinal (Thymic) Large B-Cell Lymphoma Children Nivolumab

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Dmitry Rogachev National Research Center, Moscow, Russia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Prednisolone, Rituximab

Primary outcomes

  1. Event free survival

    Time frame: 5 year

    Kaplan-Meyer estimate

Secondary outcomes

  1. Overall survival

    Time frame: 5 year

    Kaplan-Meyer estimate

  2. Progression free survival

    Time frame: 5 year

    Kaplan-Meyer estimate

Sponsors and collaborators

Lead sponsor

St. Petersburg State Pavlov Medical University

Other

Registry information

Important dates

Study start
2024
Primary completion
2029
Study completion
2031
First posted
Mar 11, 2025
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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