BrEto-TCL - Defining the Role of Brentuximab and Etoposide for Optimizing First-line Therapy of T-cell Lymphomas
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Doxorubicin, Vincristine, Etoposide, cyclophosphamide.
- Who it may be relevant to
- Registry conditions: Peripheral T-cell Lymphoma. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Optimization of the First-line Therapy of T-cell Lymphomas
Overview
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.
Interventions
- 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
Primary outcome measures
- complete response rate [Time frame: Up to 8 months]
Secondary outcome measures (3)
- Incidence of Adverse Events (AEs) [Time frame: Up to 8 months]
- Progression-free Survival [Time frame: up to 1 year]
- Overall Survival (OS) [Time frame: up to 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07258680 · BrEto-TCL