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

N.N. Petrov National Medical Research Center of Oncology

Status and phase: Invitation-only; Phase 3

Conditions: Peripheral T-cell Lymphoma

Treatments: Drug: cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Brentuximab Vedotin (Bv); Drug: Etoposide; Drug: Prednisone

Study type: Interventional

Funder types: Other

Identifiers

NCT07258680

BrEto-TCL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 4 patient groups

1st group - CHOEP

Active Comparator group

Description:

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)

Treatment:

Drug: Prednisone

Drug: Etoposide

Drug: Vincristine

Drug: Doxorubicin

Drug: cyclophosphamide

2nd group - CHOP

Active Comparator group

Description:

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)

Treatment:

Drug: Prednisone

Drug: Vincristine

Drug: Doxorubicin

Drug: cyclophosphamide

3rd group - CHP-Bv

Active Comparator group

Description:

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)

Treatment:

Drug: Prednisone

Drug: Brentuximab Vedotin (Bv)

Drug: Doxorubicin

Drug: cyclophosphamide

4th group - CHEP-Bv

Active Comparator group

Description:

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)

Treatment:

Drug: Prednisone

Drug: Etoposide

Drug: Brentuximab Vedotin (Bv)

Drug: Doxorubicin

Drug: cyclophosphamide