BrEto-TCL

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE3

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2028-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Brentuximab Vedotin in Combination With CHEP in Patient With PTCL

NCT05006664

Lymphoma, T-Cell, Peripheral

UNKNOWN PHASE2

Study of Brentuximab Vedotin Combined With RCHOP or RCHP in Front-line Treatment of Patients With Diffuse Large B-cell Lymphoma (DLBCL)

NCT01925612

Lymphoma, B-cell Lymphoma, Large B-cell, Diffuse

TERMINATED PHASE2

BV-CHEP Chemotherapy for Adult T-cell Leukemia or Lymphoma

NCT03264131

Lymphoma Adult T-Cell Leukemia/Lymphoma Lymphatic Diseases

ACTIVE_NOT_RECRUITING PHASE2

B-MAD Chemotherapy in Newly-diagnosed Extranodal NK/ T-cell Lymphoma

NCT03246750

Extranodal NK/T-cell Lymphoma

COMPLETED PHASE1/PHASE2

Bortezomib, Combination Chemotherapy, and Rituximab as First-Line Therapy in Treating Patients With Stage III or Stage IV Follicular Non-Hodgkin's Lymphoma

NCT00428142

Lymphoma

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral T-cell Lymphoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Intervention Type DRUG

cyclophosphamide 750 mg/m2, day 1

Prednisone

Intervention Type DRUG

prednisone 100 mg, 1-5 days

Brentuximab Vedotin (Bv)

Intervention Type DRUG

brentuximab vedotin 1.8 mg / kg, day 1

brentuximab vedotin 1.8 mg / kg, day 1

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No