Real-life Experience of Brentuximab Vedotin Plus CHP as First-line Treatment of CD30+ Peripheral T-cell Lymphomas in Spain
29 mai 2026 mis à jour par: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Observationnel
Inscription (Estimé)
100
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Eva Domingo Domenech, MD
- Numéro de téléphone: 932697750
- E-mail: edomingo@iconcologia.net
Lieux d'étude
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A Coruña
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A Coruña, A Coruña, Espagne, 15006
- Recrutement
- Hospital Universitario A Coruna
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Contact:
- DANIEL GARCIA GARCIA
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Chercheur principal:
- DANIEL GARCIA GARCIA
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Balearic Islands
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Palma de Mallorca, Balearic Islands, Espagne, 07008
- Recrutement
- Hospital Universitari Son Llàtzer
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Contact:
- RAQUEL DEL CAMPO
-
Chercheur principal:
- RAQUEL DEL CAMPO
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Palma de Mallorca, Balearic Islands, Espagne, 07120
- Recrutement
- Hospital Universitari Son Espases
-
Chercheur principal:
- ANTONIO GUTIERREZ
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Contact:
- ANTONIO GUTIERREZ
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Barcelona
-
Badalona, Barcelona, Espagne, 08916
- Recrutement
- Ico Hospital Germans Trias I Pujol
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Contact:
- MIREIA FRANCH
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Chercheur principal:
- MIREIA FRANCH
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Barcelona, Barcelona, Espagne, 08036
- Recrutement
- Hospital Clinic de Barcelona
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Contact:
- LAURA MAGNANO
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Chercheur principal:
- LAURA MAGNANO
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Barcelona, Barcelona, Espagne, 08003
- Recrutement
- Hospital Del Mar
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Contact:
- BLANCA SANCHEZ
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Chercheur principal:
- BLANCA SANCHEZ
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Barcelona, Barcelona, Espagne, 08035
- Recrutement
- Hospital Universitari Vall d'Hebron
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Contact:
- ANGEL SERNA PAREJA
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Chercheur principal:
- ANGEL SERNA PAREJA
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Barcelona, Barcelona, Espagne, 08041
- Recrutement
- Hospital de La Santa Creu i Sant Pau
-
Chercheur principal:
- ANA MUNTAÑOLA PRAT
-
Contact:
- ANA MUNTAÑOLA PRAT
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L'Hospitalet de Llobregat, Barcelona, Espagne, 08908
- Recrutement
- ICO Hospital Duran i Reynals
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Chercheur principal:
- Eva Domingo Domenech
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Contact:
- EVA DOMINGO DOMENECH
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Sant Joan Despí, Barcelona, Espagne, 08970
- Recrutement
- Hospital Moisès Broggi
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Contact:
- ALESSANDRA COMAI
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Chercheur principal:
- ALESSANDRA COMAI
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Cantabria
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Santander, Cantabria, Espagne, 39008
- Recrutement
- Hospital Universitario Marqués de Valdecilla
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Contact:
- SONIA GONZALEZ DE VILLAMBROSI
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Chercheur principal:
- SONIA GONZALEZ DE VILLAMBROSI
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Cádiz
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Jerez de la Frontera, Cádiz, Espagne, 11407
- Recrutement
- Hospital Universitario de Jerez
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Contact:
- ROCIO FE BITAUBE
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Chercheur principal:
- ROCIO FE BITAUBE
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Gipuzkoa
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San Sebastián, Gipuzkoa, Espagne, 20014
- Recrutement
- Hospital Universitario Donostia
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Contact:
- IZASKUN ZEBERIO
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Chercheur principal:
- IZASKUN ZEBERIO
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Girona
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Girona, Girona, Espagne, 17007
- Recrutement
- ICO Girona - Hospital Dr. Josep Trueta
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Contact:
- MARIA CERDÁ SABATER
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Chercheur principal:
- MARIA CERDÁ SABATER
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Huelva
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Huelva, Huelva, Espagne, 21005
- Recrutement
- Hospital Universitario Juan Ramón Jiménez
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Contact:
- SOFIA VAZQUEZ
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Chercheur principal:
- SOFIA VAZQUEZ
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Las Palmas
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Las Palmas de Gran Canaria, Las Palmas, Espagne, 35010
- Recrutement
- Hospital Universitario Doctor Negrin
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Contact:
- HARIDIAN DE LA NUEZ MELIAN
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Chercheur principal:
- HARIDIAN DE LA NUEZ MELIAN
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Madrid
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Alcalá de Henares, Madrid, Espagne, 28805
- Recrutement
- Hospital Universitario Príncipe de Asturias
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Contact:
- PAOLA VILLAFUERTE GUTIERREZ
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Chercheur principal:
- PAOLA VILLAFUERTE GUTIERREZ
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Arganda, Madrid, Espagne, 28500
- Recrutement
- Hospital del Sureste
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Contact:
- TERESA COBO RODRIGUEZ
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Chercheur principal:
- TERESA COBO RODRIGUEZ
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Leganés, Madrid, Espagne, 28911
- Recrutement
- Hospital Universitario Severo Ochoa
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Contact:
- MARIA LUISA BENGOCHEA
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Chercheur principal:
- MARIA LUISA BENGOCHEA
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Madrid, Madrid, Espagne, 28034
- Recrutement
- Hospital Universitario Ramon y Cajal
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Contact:
- FERNANDO MARTIN MORO
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Chercheur principal:
- FERNANDO MARTIN MORO
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Madrid, Madrid, Espagne, 28041
- Recrutement
- Hospital Universitario 12 de Octubre
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Chercheur principal:
- ANTONIA RODRIGUEZ IZQUIERDO
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Contact:
- ANTONIA RODRIGUEZ IZQUIERDO
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Madrid, Madrid, Espagne, 28006
- Recrutement
- Hospital Universitario de La Princesa
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Contact:
- ANA GARCIA NOBLEJAS
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Chercheur principal:
- ANA GARCIA NOBLEJAS
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Madrid, Madrid, Espagne, 28007
- Recrutement
- Hospital Universitario Gregorio Marañón
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Contact:
- PAULA FERNANDEZ CALDAS
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Chercheur principal:
- PAULA FERNANDEZ CALDAS
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Móstoles, Madrid, Espagne, 28933
- Recrutement
- Hospital Universitario Rey Juan Carlos
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Contact:
- GABRIELA SALVATIERRA CALDERON
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Chercheur principal:
- GABRIELA SALVATIERRA CALDERON
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Murcia
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Cartagena, Murcia, Espagne, 30202
- Recrutement
- Hospital General Universitario Santa Lucía
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Contact:
- ANA BELEN ARROYO RODRIGUEZ
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Chercheur principal:
- ANA BELEN ARROYO RODRIGUEZ
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Murcia, Murcia, Espagne, 30008
- Recrutement
- Hospital Universitario Morales Meseguer
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Contact:
- JOSE JAVIER SANCHEZ BLANCO
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Chercheur principal:
- JOSE JAVIER SANCHEZ BLANCO
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Navarre
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Pamplona, Navarre, Espagne, 31008
- Recrutement
- Clinica Universidad de Navarra
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Contact:
- CARLOS GRANDE
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Chercheur principal:
- CARLOS GRANDE
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Pontevedra
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Vigo, Pontevedra, Espagne, 36213
- Recrutement
- Hospital Alvaro Cunqueiro
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Contact:
- ROSA MARIA RODRIGUEZ NUÑEZ
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Chercheur principal:
- ROSA MARIA RODRIGUEZ NUÑEZ
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Principality of Asturias
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Avilés, Principality of Asturias, Espagne, 33401
- Recrutement
- Hospital Universitario San Agustín
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Contact:
- MARIA ARGÜELLO JUNQUERA
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Chercheur principal:
- MARIA ARGÜELLO JUNQUERA
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Oviedo, Principality of Asturias, Espagne, 33011
- Recrutement
- Hospital Universitario Central de Asturias
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Contact:
- LUCIA MORAIS
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Chercheur principal:
- LUCIA MORAIS
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Salamanca
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Salamanca, Salamanca, Espagne, 37007
- Recrutement
- Hospital Universitario De Salamanca
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Contact:
- ALEJANDRO MARTIN
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Chercheur principal:
- ALEJANDRO MARTIN
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Santa Cruz de Tenerife
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San Cristóbal de La Laguna, Santa Cruz de Tenerife, Espagne, 38320
- Recrutement
- Hospital Universitario de Canarias
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Contact:
- CAROLINA DE BONIS
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Chercheur principal:
- CAROLINA DE BONIS
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Segovia
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Segovia, Segovia, Espagne, 40002
- Recrutement
- Hospital General de Segovia
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Contact:
- ANA TORRES
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Chercheur principal:
- ANA TORRES
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Sevilla
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Seville, Sevilla, Espagne, 41009
- Recrutement
- Hospital Universitario Virgen Macarena
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Contact:
- NAZARET DOMINGUEZ VELASCO
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Chercheur principal:
- NAZARET DOMINGUEZ VELASCO
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Tarragona
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Tarragona, Tarragona, Espagne, 43005
- Recrutement
- ICO Hospital Universitari Joan XXIII
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Contact:
- JORDINA ROVIRA SOLE
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Chercheur principal:
- JORDINA ROVIRA SOLE
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Valencia
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Gandia, Valencia, Espagne, 46702
- Recrutement
- Hospital Francesc de Borja
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Contact:
- ALBERT BLANCO JUAN
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Chercheur principal:
- ALBERT BLANCO JUAN
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Valencia, Valencia, Espagne, 46026
- Recrutement
- Hospital Universitari i Politecnic La Fe
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Contact:
- SAMUEL ROMERO DOMINGUEZ
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Chercheur principal:
- SAMUEL ROMERO DOMINGUEZ
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
BV-CHP First-Line Treatment Cohort
This cohort includes adult participants diagnosed with CD30-positive peripheral T-cell lymphoma who received brentuximab vedotin in combination with cyclophosphamide, doxorubicin, and prednisone (BV-CHP) as first-line treatment as part of routine clinical practice in Spain.
Data are collected retrospectively from medical records to evaluate treatment outcomes and safety in a real-world setting.
|
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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Progression-Free Survival (PFS)
Délai: From enrollment until disease progression, relapse, death, or last follow-up, assessed up to approximately 68 months.
|
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
|
From enrollment until disease progression, relapse, death, or last follow-up, assessed up to approximately 68 months.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Overall Response Rate (ORR) and Complete Response (CR) as Efficacy Outcomes
Délai: During first-line treatment, assessed up to approximately 12 months
|
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.
|
During first-line treatment, assessed up to approximately 12 months
|
|
Overall Survival (OS)
Délai: From enrollment until disease progression, relapse, death, or last follow-up, assessed up to approximately 68 months.
|
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.
|
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
Délai: During first-line treatment, assessed up to approximately 12 months
|
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
|
During first-line treatment, assessed up to approximately 12 months
|
|
CD30 Expression at Diagnosis
Délai: At diagnosis (baseline
|
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.
|
At diagnosis (baseline
|
|
Treatment Response Assessed by Interim and End-of-Treatment PET/CT
Délai: During first-line treatment, assessed up to approximately 12 months
|
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
|
During first-line treatment, assessed up to approximately 12 months
|
|
Impact of histological subtype (ALCL vs non-ALCL) on treatment efficacy
Délai: From enrollment until disease progression, relapse, death, or last follow-up, assessed up to approximately 68 months
|
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
|
From enrollment until disease progression, relapse, death, or last follow-up, assessed up to approximately 68 months
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
15 février 2026
Achèvement primaire (Estimé)
1 novembre 2026
Achèvement de l'étude (Estimé)
1 mai 2027
Dates d'inscription aux études
Première soumission
27 avril 2026
Première soumission répondant aux critères de contrôle qualité
29 mai 2026
Première publication (Réel)
3 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
3 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
29 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Tumeurs
- Maladies du système immunitaire
- Tumeurs par type histologique
- Maladies lymphatiques
- Troubles lymphoprolifératifs
- Troubles immunoprolifératifs
- Lymphome non hodgkinien
- Lymphome
- Lymphome à cellules T
- Maladies hémiques et lymphatiques
- Lymphome, lymphocyte T, périphérique
- Peptides
- Acides aminés, peptides et protéines
- Oligopeptides
- Protéines
- Anticorps, monoclonal, humanisé
- Anticorps, monoclonal
- Anticorps
- Immunoglobulines
- Immunoprotéines
- Protéines sanguines
- Globulines sériques
- Globulines
- Brentuximab Védotine
- somatostatine, hexapeptide cyclique (Phe-Phe-Trp-Lys-Thr-Phe)-
Autres numéros d'identification d'étude
- GELTAMO-BVCHP-2021-003
- IISR-2021-200184 (Autre identifiant: Geltamo)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .