Real-life Experience of Brentuximab Vedotin Plus CHP as First-line Treatment of CD30+ Peripheral T-cell Lymphomas in Spain
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: Brentuximab Vedotin Plus CHP.
- Who it may be relevant to
- Registry conditions: CD30-Positive Peripheral T-Cell Lymphoma. Basic parameters: from 18 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
- Spain
- 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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Overview
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.
Interventions
- Drug Brentuximab Vedotin Plus CHP
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
Primary outcome measures
- Progression-Free Survival (PFS) [Time frame: From enrollment until disease progression, relapse, death, or last follow-up, assessed up to approximately 68 months.]
Secondary outcome measures (6)
- Overall Response Rate (ORR) and Complete Response (CR) as Efficacy Outcomes [Time frame: During first-line treatment, assessed up to approximately 12 months]
- Overall Survival (OS) [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 [Time frame: During first-line treatment, assessed up to approximately 12 months]
- CD30 Expression at Diagnosis [Time frame: At diagnosis (baseline]
- Treatment Response Assessed by Interim and End-of-Treatment PET/CT [Time frame: During first-line treatment, assessed up to approximately 12 months]
- Impact of histological subtype (ALCL vs non-ALCL) on treatment efficacy [Time frame: From enrollment until disease progression, relapse, death, or last follow-up, assessed up to approximately 68 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Patients who have received prior treatment for their lymphoma
- Patients who have received the combination as part of a clinical trial.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 37 centers
- Hospital Universitario A Coruña — A Coruña
- Hospital Universitari Son Llàtzer — Palma de Mallorca
- Hospital Universitari Son Espases — Palma de Mallorca
- ICO Hospital Germans Trias i Pujol — Badalona
- Hospital del Mar — Barcelona
- Hospital Universitari Vall d'Hebron — Barcelona
- Hospital Clínic de Barcelona — Barcelona
- Hospital de la Santa Creu i Sant Pau — Barcelona
- … and 29 more centers
Identifiers
NCT: NCT07624838 · GELTAMO-BVCHP-2021-003 · IISR-2021-200184