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Enrolling by Invitation

NCT Number: NCT07258680

BrEto-TCL - Defining the Role of Brentuximab and Etoposide for Optimizing First-line Therapy of T-cell Lymphomas

There is no data comparing the effectiveness of the 4 most relevant first-line therapy programs for peripheral T-cell lymphomas (CHOEP, CHOP, CHEP-BV, CHP-BV) in a single study.

For the first time, the effectiveness and toxicity of various first-line PTCL therapy programs in patients with T-cell lymphoma will be analyzed in the conditions of a single medical center of the N.N.Petrov National Research Medical Center of Oncology and optimal therapeutic tactics will be determined, taking into account significant prognostic factors based on effectiveness and toxicity a specific chemotherapy regimen.

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Key information

Conditions

Peripheral T-cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Peripheral Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

A non-randomized retrospective cohort study with prospective inclusion is planned.

Patients with a confirmed diagnosis of PTCL (who meet the inclusion criteria) who were treated at the same center of the NN Petrov National Medical Cancer Research Center from 2013 to 2024, depending on the first-line therapy regimen, will be included in the retrospective part of the study and divided into 2 groups: Group 1: CHOEP regimen Group 2: CHOP regimen

The prospective part of this study is planned to include patients (who meet the inclusion criteria) who are hospitalized at the NN Petrov National Medical Cancer Research Center for treatment from January 2024 to January 2027. Patients will be divided into 2 groups depending on the chemotherapy regimen:

Group 3: chemoimmunotherapy according to the CHP-BV regimen Group 4: chemoimmunotherapy according to the CHEP-BV regimen Based on the data from the medical documentation of patients, the main statistical indicators of the effectiveness of first-line treatment regimens will be calculated using objective methods for assessing the antitumor effect (PET CT, CT), the toxicity of each of the regimens will be assessed, as well as possible prognostic factors for all patient groups.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with newly diagnosed mature T-cell lymphomas
  • absence of acute infectious diseases during treatment diseases, chronic diseases in the stage of decompensation
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2

Exclusion criteria

  • the presence of a history of other malignant neoplasms during the 5-year period before the start of first-line therapy, In addition to in situ neoplasms treated according to appropriate treatment protocols,
  • there are acute infectious diseases and chronic diseases in the decompensation stage.

Treatment and study plan

Doxorubicin

Drug

doxorubicin 50 mg/m2, day 1

Vincristine

Drug

vincristine 1.4 mg/m2, (maximum dose 2 mg) day 1

etoposide

Drug

Etoposide 100 mg/m2, 1-3 days

Cyclophosphamide

Drug

cyclophosphamide 750 mg/m2, day 1

Prednisone

Drug

prednisone 100 mg, 1-5 days

Brentuximab Vedotin (Bv)

Drug

brentuximab vedotin 1.8 mg / kg, day 1

Primary outcomes

  1. complete response rate

    Time frame: Up to 8 months

    • Primary endpoints: the complete response rate - The count of participants with CR per IRF following the completion of study treatment (at end of treatment or at the first assessment after the last dose of study treatment and prior to long-term follow-up) according to the Revised Response Criteria for Malignant Lymphoma.

Secondary outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: Up to 8 months

    Any untoward medical occurrence in a clinical investigational participant administered a medicinal product which does not necessarily have a causal relationship with this treatment.

  2. Progression-free Survival

    Time frame: up to 1 year

    The time from the date of randomization to the date of first documentation of progressive disease (PD), death due to any cause, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease whichever occurred first.

  3. Overall Survival (OS)

    Time frame: up to 1 year

    The time from randomization to death due to any cause.

Sponsors and collaborators

Lead sponsor

N.N. Petrov National Medical Research Center of Oncology

Other

Registry information

Official study title

Optimization of the First-line Therapy of T-cell Lymphomas

Acronym: BrEto-TCL

Important dates

Study start
2013
Primary completion
2028
Study completion
2028
First posted
Dec 2, 2025
Registry last updated
Dec 2, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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