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

NCT07258680 | Enrolling By Invitation Phase 3

• 1 other identifier: BrEto-TCL
• Study Type: interventional
• Target: 114
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Peripheral T-cell Lymphoma

Keywords

PTCL; Peripheral T-Cell Lymphoma; brentuximab vedotin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Incidence of Adverse Events (AEs)

  Up to 8 months

• Progression-free Survival

  up to 1 year

• Overall Survival (OS)

  up to 1 year

Study Arms (4)

1st group - CHOEP

ACTIVE COMPARATOR

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; Drug: Vincristine; Drug: Etoposide; Drug: cyclophosphamide; Drug: Prednisone

2nd group - CHOP

ACTIVE COMPARATOR

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; Drug: Vincristine; Drug: cyclophosphamide; Drug: Prednisone

3rd group - CHP-Bv

ACTIVE COMPARATOR

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; Drug: cyclophosphamide; Drug: Prednisone; Drug: Brentuximab Vedotin (Bv)

4th group - CHEP-Bv

ACTIVE COMPARATOR

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; Drug: Etoposide; Drug: cyclophosphamide; Drug: Prednisone; Drug: Brentuximab Vedotin (Bv)

Interventions

Doxorubicin DRUG

doxorubicin 50 mg/m2, day 1

1st group - CHOEP; 2nd group - CHOP; 3rd group - CHP-Bv; 4th group - CHEP-Bv

Vincristine DRUG

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

1st group - CHOEP; 2nd group - CHOP

Etoposide DRUG

Etoposide 100 mg/m2, 1-3 days

1st group - CHOEP; 4th group - CHEP-Bv

cyclophosphamide DRUG

cyclophosphamide 750 mg/m2, day 1

1st group - CHOEP; 2nd group - CHOP; 3rd group - CHP-Bv; 4th group - CHEP-Bv

Prednisone DRUG

prednisone 100 mg, 1-5 days

1st group - CHOEP; 2nd group - CHOP; 3rd group - CHP-Bv; 4th group - CHEP-Bv

Brentuximab Vedotin (Bv) DRUG

brentuximab vedotin 1.8 mg / kg, day 1

3rd group - CHP-Bv; 4th group - CHEP-Bv

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

Doxorubicin; Vincristine; Etoposide; Cyclophosphamide; Prednisone; Brentuximab Vedotin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oncologist

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 2, 2025
• Study Start: October 1, 2013
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share