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 volunteersQualifiers
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
Cohort
Retrospective
Treatments tested in this trial
Brentuximab Vedotin Plus CHP
DrugBrentuximab 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
Trial outcomes
Primary outcomes
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
Secondary outcomes
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.
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.
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
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.
Sponsors and contacts
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