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.
Study Type
OBSERVATIONAL
Enrollment
100
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
Hospital Universitario A Coruña
A Coruña, A Coruña, Spain
RECRUITINGHospital Universitari Son Llàtzer
Palma de Mallorca, Balearic Islands, Spain
RECRUITINGHospital Universitari Son Espases
Palma de Mallorca, Balearic Islands, Spain
RECRUITINGICO Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
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.
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
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.
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
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
Treatment Response Assessed by Interim and End-of-Treatment PET/CT
Assessment of response status on interim and end-of-treatment PET/CT imaging as reported in local clinical practice, and its exploratory association with survival outcomes, in adult participants with CD30-positive peripheral T-cell lymphoma treated with brentuximab vedotin plus CHP
Time frame: During first-line treatment, assessed up to approximately 12 months
Impact of histological subtype (ALCL vs non-ALCL) on treatment efficacy
Evaluation of the impact of histological subtype on treatment efficacy in patients with CD30-positive peripheral T-cell lymphoma treated with brentuximab vedotin plus CHP as first-line therapy, comparing outcomes between anaplastic large cell lymphoma (ALCL) and non-ALCL subtypes in routine clinical practice
Time frame: From enrollment until disease progression, relapse, death, or last follow-up, assessed up to approximately 68 months
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Hospital del Mar
Barcelona, Barcelona, Spain
RECRUITINGHospital Universitari Vall d'Hebron
Barcelona, Barcelona, Spain
RECRUITINGHospital Clínic de Barcelona
Barcelona, Barcelona, Spain
RECRUITINGHospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
RECRUITINGICO Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, Spain
RECRUITINGHospital Moisès Broggi
Sant Joan Despí, Barcelona, Spain
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