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Peripheral T-cell LymphomaPhase 3BrEto-TCLNCT07258680

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

A Phase 3 study testing Doxorubicin, Vincristine and Etoposide in people with Peripheral T-cell Lymphoma, run by N.N. Petrov National Medical Research Center of Oncology.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Peripheral T-cell Lymphoma
What is being tested?
Doxorubicin, Vincristine and Etoposide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
No sites listed yet
Study dates
Oct 2013to Dec 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

About this study

Official title: Optimization of the First-line Therapy of T-cell Lymphomas

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.

Read the 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.

Keywords
PTCL, Peripheral T-Cell Lymphoma, brentuximab vedotin
Medical subject headings
Lymphoma, T-Cell, Peripheral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DoxorubicinDrug

    doxorubicin 50 mg/m2, day 1

  • VincristineDrug

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

  • EtoposideDrug

    Etoposide 100 mg/m2, 1-3 days

  • cyclophosphamideDrug

    cyclophosphamide 750 mg/m2, day 1

  • PrednisoneDrug

    prednisone 100 mg, 1-5 days

  • Brentuximab Vedotin (Bv)Drug

    brentuximab vedotin 1.8 mg / kg, day 1

Study groups in NCT07258680
Study groupRoleWhat they receive
1st group - CHOEPActive comparatorTherapy 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)
Receives: Drug: Doxorubicin; Drug: Vincristine; Drug: Etoposide; Drug: cyclophosphamide; Drug: Prednisone
2nd group - CHOPActive comparatorThe 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)
Receives: Drug: Doxorubicin; Drug: Vincristine; Drug: cyclophosphamide; Drug: Prednisone
3rd group - CHP-BvActive comparatorTherapy 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)
Receives: Drug: Doxorubicin; Drug: cyclophosphamide; Drug: Prednisone; Drug: Brentuximab Vedotin (Bv)
4th group - CHEP-BvActive comparatorThe therapy of patients in the 4th group is carried out according to the CHEP-Bv scheme (6 courses with an interval of 21 days)
Receives: Drug: Doxorubicin; Drug: Etoposide; Drug: cyclophosphamide; Drug: Prednisone; Drug: Brentuximab Vedotin (Bv)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 8 months

Secondary outcomes (3)

  1. Incidence of Adverse Events (AEs)

    Any untoward medical occurrence in a clinical investigational participant administered a medicinal product which does not necessarily have a causal relationship with this treatment.

    Measured: Up to 8 months

  2. Progression-free Survival

    The time from the date of randomization to the date of first documentation of progressive disease (PD), death due to any cause, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease whichever occurred first.

    Measured: up to 1 year

  3. Overall Survival (OS)

    The time from randomization to death due to any cause.

    Measured: up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2025
  2. Study startOct 2013
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
114 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07258680
Sponsor's protocol ID
BrEto-TCL
Acronym
BrEto-TCL
Status last verified
Nov 2025
First submitted
14 Nov 2025
Last updated
2 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Doxorubicin, Vincristine and Etoposide in people with Peripheral T-cell Lymphoma, run by N.N. Petrov National Medical Research Center of Oncology.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

complete response rate (time frame: Up to 8 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07258680.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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