Меню
Идёт набор NCT07624838

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

— Наблюдательное CD30-Positive Peripheral T-Cell Lymphoma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Brentuximab Vedotin Plus CHP.
Кому может быть актуально
Состояния в реестре: CD30-Positive Peripheral T-Cell Lymphoma. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Испания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

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.

Вмешательства

  • Препарат 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

Первичные конечные точки

  • Progression-Free Survival (PFS) [Срок оценки: From enrollment until disease progression, relapse, death, or last follow-up, assessed up to approximately 68 months.]
Вторичные конечные точки (6)
  • Overall Response Rate (ORR) and Complete Response (CR) as Efficacy Outcomes [Срок оценки: During first-line treatment, assessed up to approximately 12 months]
  • Overall Survival (OS) [Срок оценки: 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 [Срок оценки: During first-line treatment, assessed up to approximately 12 months]
  • CD30 Expression at Diagnosis [Срок оценки: At diagnosis (baseline]
  • Treatment Response Assessed by Interim and End-of-Treatment PET/CT [Срок оценки: During first-line treatment, assessed up to approximately 12 months]
  • Impact of histological subtype (ALCL vs non-ALCL) on treatment efficacy [Срок оценки: From enrollment until disease progression, relapse, death, or last follow-up, assessed up to approximately 68 months]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • Patients who have received prior treatment for their lymphoma
  • Patients who have received the combination as part of a clinical trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Испания · 37 центров
  • 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
  • … и ещё 29 центров

Идентификаторы

NCT: NCT07624838 · GELTAMO-BVCHP-2021-003 · IISR-2021-200184

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗