Real-life Experience of Brentuximab Vedotin Plus CHP as First-line Treatment of CD30+ Peripheral T-cell Lymphomas in Spain

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGrupo Español de Linfomas y Transplante Autólogo de Médula Ósea

About this trial

The goal of this observational study is to evaluate how well brentuximab vedotin plus cyclophosphamide, doxorubicin, and prednisone (CHP) works and how safe it is when used as first-line treatment in adults with CD30-positive peripheral T-cell lymphoma in Spain during routine clinical care.

The main questions this study aims to answer are:

* How long do participants live without their lymphoma getting worse after starting treatment? * How well does this treatment reduce or eliminate the lymphoma? * How long do participants live after receiving this treatment? * What side effects do participants experience, including nerve problems and low white blood cell counts?

Participants have already received brentuximab vedotin plus CHP as part of their usual medical care. Researchers will collect information from existing medical records to better understand treatment outcomes and safety in real-world clinical practice across multiple centers in Spain.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of CD30-positive peripheral T-cell lymphoma, including anaplastic large cell lymphoma (ALK-positive, ALK-negative, breast implant-associated), peripheral T-cell lymphoma not otherwise specified, angioimmunoblastic T-cell lymphoma, hepatosplenic T-cell lymphoma, or enteropathy-associated T-cell lymphoma.

Patients 18 years of age or older at the time of treatment with BV-CHP.

Patients treated with brentuximab vedotin plus CHP as first-line therapy between January 2019 and September 2024

Disqualifiers

Patients who have received prior treatment for their lymphoma

Patients who have received the combination as part of a clinical trial.

Trial population

The study population consists of adult patients (18 years of age or older) diagnosed with CD30-positive peripheral T-cell lymphoma who received brentuximab vedotin plus cyclophosphamide, doxorubicin, and prednisone (BV-CHP) as first-line treatment in routine clinical practice in Spain. All patients were treated between January 2019 and September 2024 and were identified retrospectively through review of existing medical records, including the RELINF registry of the GELTAMO group. No treatment interventions or assignments were made as part of the study.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Brentuximab Vedotin Plus CHP

    Drug

    Brentuximab vedotin administered in combination with cyclophosphamide, doxorubicin, and prednisone (BV-CHP) as first-line treatment according to routine clinical practice. The treatment was prescribed by the treating physician as part of standard medical care and was not assigned or modified by the study

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: BV-CHP First-Line Treatment Cohort1 intervention

Trial outcomes

Primary outcomes

1

Progression-Free Survival (PFS)

Progression-free survival of brentuximab vedotin plus CHP as first-line treatment in adult participants with CD30-positive peripheral T-cell lymphoma, defined as the time from registration until disease progression or relapse, or death from any cause. Initiation of the subsequent line of therapy is considered an event

Time frame
From enrollment until disease progression, relapse, death, or last follow-up, assessed up to approximately 68 months.

Secondary outcomes

1

Overall Response Rate (ORR) and Complete Response (CR) as Efficacy Outcomes

Overall response rate (ORR) and complete response (CR) as measures of treatment effectiveness in adult participants with CD30-positive peripheral T-cell lymphoma treated with brentuximab vedotin plus CHP as first-line treatment, based on local PET/CT and/or CT imaging reports.

Time frame
During first-line treatment, assessed up to approximately 12 months
2

Overall Survival (OS)

Overall survival (OS) defined as the time from enrollment until death from any cause in adult participants with CD30-positive peripheral T-cell lymphoma treated with brentuximab vedotin plus CHP.

Time frame
From enrollment until disease progression, relapse, death, or last follow-up, assessed up to approximately 68 months.
3

Incidence and Type of Treatment-Related Adverse Events

Incidence and characterization of treatment-related adverse events associated with brentuximab vedotin plus CHP during first-line treatment, with special interest in neuropathy and neutropenia, as documented in medical records

Time frame
During first-line treatment, assessed up to approximately 12 months
4

CD30 Expression at Diagnosis

Assessment of CD30 expression percentage based on local pathology reports at the time of lymphoma diagnosis in adult participants with peripheral T-cell lymphoma treated with brentuximab vedotin plus CHP.

Time frame
At diagnosis (baseline

Other outcomes

Sponsors and contacts

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