NCT07258680

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

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

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 114 (estimated)
• Sponsor: N.N. Petrov National Medical Research Center of Oncology · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Peripheral T-cell Lymphoma

Interventions

Type	Name	Description
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
DRUG	Brentuximab Vedotin (Bv)	brentuximab vedotin 1.8 mg / kg, day 1

Timeline

• Start date: 2013-10-01
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2025-12-02
• Last updated: 2025-12-02