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

Optimization of the 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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Peripheral T-cell Lymphoma
• Intervention / Treatment: Drug: Doxorubicin; Drug: Vincristine; Drug: Etoposide; Drug: cyclophosphamide; Drug: Prednisone; Drug: Brentuximab Vedotin (Bv)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 114
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1st group - CHOEP; Therapy of patients in the 1st group of the study is carried out according to the CHOEP scheme (6 courses with an interval of 21 days)	Drug: Doxorubicin; doxorubicin 50 mg/m2, day 1; Drug: Vincristine; vincristine 1.4 mg/m2, (maximum dose 2 mg) day 1; Drug: Etoposide; Etoposide 100 mg/m2, 1-3 days; Drug: cyclophosphamide; cyclophosphamide 750 mg/m2, day 1; Drug: Prednisone; prednisone 100 mg, 1-5 days
Active Comparator: 2nd group - CHOP; The therapy of patients in the 2nd group of the study is carried out according to the CHOP scheme (6 courses with an interval of 21 days)	Drug: Doxorubicin; doxorubicin 50 mg/m2, day 1; Drug: Vincristine; vincristine 1.4 mg/m2, (maximum dose 2 mg) day 1; Drug: cyclophosphamide; cyclophosphamide 750 mg/m2, day 1; Drug: Prednisone; prednisone 100 mg, 1-5 days
Active Comparator: 3rd group - CHP-Bv; Therapy of patients of the 3rd group of the study is carried out according to the CHP-Bv scheme (6 courses with an interval of 21 days)	Drug: Doxorubicin; doxorubicin 50 mg/m2, day 1; Drug: cyclophosphamide; cyclophosphamide 750 mg/m2, day 1; Drug: Prednisone; prednisone 100 mg, 1-5 days; Drug: Brentuximab Vedotin (Bv); brentuximab vedotin 1.8 mg / kg, day 1
Active Comparator: 4th group - CHEP-Bv; The therapy of patients in the 4th group is carried out according to the CHEP-Bv scheme (6 courses with an interval of 21 days)	Drug: Doxorubicin; doxorubicin 50 mg/m2, day 1; Drug: Etoposide; Etoposide 100 mg/m2, 1-3 days; Drug: cyclophosphamide; cyclophosphamide 750 mg/m2, day 1; Drug: Prednisone; prednisone 100 mg, 1-5 days; Drug: Brentuximab Vedotin (Bv); brentuximab vedotin 1.8 mg / kg, day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complete response rate	- 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.	Up to 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events (AEs)	Any untoward medical occurrence in a clinical investigational participant administered a medicinal product which does not necessarily have a causal relationship with this treatment.	Up to 8 months
Progression-free Survival	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.	up to 1 year
Overall Survival (OS)	The time from randomization to death due to any cause.	up to 1 year

Collaborators and Investigators

• Sponsor: N.N. Petrov National Medical Research Center of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2013
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Actual): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: PTCL; Peripheral T-Cell Lymphoma; brentuximab vedotin
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Hemic and Lymphatic Diseases; Lymphoma, T-Cell, Peripheral; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Proteins; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Hydrocarbons, Cyclic; Carbohydrates; Alkaloids; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Glucosides; Glycosides; Indoles; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Pregnadienediols; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Indolizidines; Indolizines; Anthracyclines; Naphthacenes; Aminoglycosides; Daunorubicin; Brentuximab Vedotin; Prednisone; Cyclophosphamide; Etoposide; Doxorubicin; Vincristine
• Other Study ID Numbers: BrEto-TCL

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