Real-life Experience of Brentuximab Vedotin Plus CHP as First-line Treatment of CD30+ Peripheral T-cell Lymphomas in Spain
29. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Antatt)
100
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Eva Domingo Domenech, MD
- Telefonnummer: 932697750
- E-post: edomingo@iconcologia.net
Studiesteder
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A Coruña
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A Coruña, A Coruña, Spania, 15006
- Rekruttering
- Hospital Universitario A Coruna
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Ta kontakt med:
- DANIEL GARCIA GARCIA
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Hovedetterforsker:
- DANIEL GARCIA GARCIA
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Balearic Islands
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Palma de Mallorca, Balearic Islands, Spania, 07008
- Rekruttering
- Hospital Universitari Son Llàtzer
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Ta kontakt med:
- RAQUEL DEL CAMPO
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Hovedetterforsker:
- RAQUEL DEL CAMPO
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Palma de Mallorca, Balearic Islands, Spania, 07120
- Rekruttering
- Hospital Universitari Son Espases
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Hovedetterforsker:
- ANTONIO GUTIERREZ
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Ta kontakt med:
- ANTONIO GUTIERREZ
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Barcelona
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Badalona, Barcelona, Spania, 08916
- Rekruttering
- Ico Hospital Germans Trias I Pujol
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Ta kontakt med:
- MIREIA FRANCH
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Hovedetterforsker:
- MIREIA FRANCH
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Barcelona, Barcelona, Spania, 08036
- Rekruttering
- Hospital Clinic de Barcelona
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Ta kontakt med:
- LAURA MAGNANO
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Hovedetterforsker:
- LAURA MAGNANO
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Barcelona, Barcelona, Spania, 08003
- Rekruttering
- Hospital Del Mar
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Ta kontakt med:
- BLANCA SANCHEZ
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Hovedetterforsker:
- BLANCA SANCHEZ
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Barcelona, Barcelona, Spania, 08035
- Rekruttering
- Hospital Universitari Vall d'Hebron
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Ta kontakt med:
- ANGEL SERNA PAREJA
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Hovedetterforsker:
- ANGEL SERNA PAREJA
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Barcelona, Barcelona, Spania, 08041
- Rekruttering
- Hospital de La Santa Creu i Sant Pau
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Hovedetterforsker:
- ANA MUNTAÑOLA PRAT
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Ta kontakt med:
- ANA MUNTAÑOLA PRAT
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L'Hospitalet de Llobregat, Barcelona, Spania, 08908
- Rekruttering
- ICO Hospital Duran i Reynals
-
Hovedetterforsker:
- Eva Domingo Domenech
-
Ta kontakt med:
- EVA DOMINGO DOMENECH
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Sant Joan Despí, Barcelona, Spania, 08970
- Rekruttering
- Hospital Moisès Broggi
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Ta kontakt med:
- ALESSANDRA COMAI
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Hovedetterforsker:
- ALESSANDRA COMAI
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Cantabria
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Santander, Cantabria, Spania, 39008
- Rekruttering
- Hospital Universitario Marqués de Valdecilla
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Ta kontakt med:
- SONIA GONZALEZ DE VILLAMBROSI
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Hovedetterforsker:
- SONIA GONZALEZ DE VILLAMBROSI
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Cádiz
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Jerez de la Frontera, Cádiz, Spania, 11407
- Rekruttering
- Hospital Universitario de Jerez
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Ta kontakt med:
- ROCIO FE BITAUBE
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Hovedetterforsker:
- ROCIO FE BITAUBE
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Gipuzkoa
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San Sebastián, Gipuzkoa, Spania, 20014
- Rekruttering
- Hospital Universitario Donostia
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Ta kontakt med:
- IZASKUN ZEBERIO
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Hovedetterforsker:
- IZASKUN ZEBERIO
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Girona
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Girona, Girona, Spania, 17007
- Rekruttering
- ICO Girona - Hospital Dr. Josep Trueta
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Ta kontakt med:
- MARIA CERDÁ SABATER
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Hovedetterforsker:
- MARIA CERDÁ SABATER
-
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Huelva
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Huelva, Huelva, Spania, 21005
- Rekruttering
- Hospital Universitario Juan Ramón Jiménez
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Ta kontakt med:
- SOFIA VAZQUEZ
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Hovedetterforsker:
- SOFIA VAZQUEZ
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-
Las Palmas
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Las Palmas de Gran Canaria, Las Palmas, Spania, 35010
- Rekruttering
- Hospital Universitario Doctor Negrin
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Ta kontakt med:
- HARIDIAN DE LA NUEZ MELIAN
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Hovedetterforsker:
- HARIDIAN DE LA NUEZ MELIAN
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Madrid
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Alcalá de Henares, Madrid, Spania, 28805
- Rekruttering
- Hospital Universitario Príncipe de Asturias
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Ta kontakt med:
- PAOLA VILLAFUERTE GUTIERREZ
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Hovedetterforsker:
- PAOLA VILLAFUERTE GUTIERREZ
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Arganda, Madrid, Spania, 28500
- Rekruttering
- Hospital del Sureste
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Ta kontakt med:
- TERESA COBO RODRIGUEZ
-
Hovedetterforsker:
- TERESA COBO RODRIGUEZ
-
Leganés, Madrid, Spania, 28911
- Rekruttering
- Hospital Universitario Severo Ochoa
-
Ta kontakt med:
- MARIA LUISA BENGOCHEA
-
Hovedetterforsker:
- MARIA LUISA BENGOCHEA
-
Madrid, Madrid, Spania, 28034
- Rekruttering
- Hospital Universitario Ramon y Cajal
-
Ta kontakt med:
- FERNANDO MARTIN MORO
-
Hovedetterforsker:
- FERNANDO MARTIN MORO
-
Madrid, Madrid, Spania, 28041
- Rekruttering
- Hospital Universitario 12 de Octubre
-
Hovedetterforsker:
- ANTONIA RODRIGUEZ IZQUIERDO
-
Ta kontakt med:
- ANTONIA RODRIGUEZ IZQUIERDO
-
Madrid, Madrid, Spania, 28006
- Rekruttering
- Hospital Universitario de La Princesa
-
Ta kontakt med:
- ANA GARCIA NOBLEJAS
-
Hovedetterforsker:
- ANA GARCIA NOBLEJAS
-
Madrid, Madrid, Spania, 28007
- Rekruttering
- Hospital Universitario Gregorio Marañón
-
Ta kontakt med:
- PAULA FERNANDEZ CALDAS
-
Hovedetterforsker:
- PAULA FERNANDEZ CALDAS
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Móstoles, Madrid, Spania, 28933
- Rekruttering
- Hospital Universitario Rey Juan Carlos
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Ta kontakt med:
- GABRIELA SALVATIERRA CALDERON
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Hovedetterforsker:
- GABRIELA SALVATIERRA CALDERON
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Murcia
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Cartagena, Murcia, Spania, 30202
- Rekruttering
- Hospital General Universitario Santa Lucía
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Ta kontakt med:
- ANA BELEN ARROYO RODRIGUEZ
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Hovedetterforsker:
- ANA BELEN ARROYO RODRIGUEZ
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Murcia, Murcia, Spania, 30008
- Rekruttering
- Hospital Universitario Morales Meseguer
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Ta kontakt med:
- JOSE JAVIER SANCHEZ BLANCO
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Hovedetterforsker:
- JOSE JAVIER SANCHEZ BLANCO
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-
Navarre
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Pamplona, Navarre, Spania, 31008
- Rekruttering
- Clinica Universidad de Navarra
-
Ta kontakt med:
- CARLOS GRANDE
-
Hovedetterforsker:
- CARLOS GRANDE
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-
Pontevedra
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Vigo, Pontevedra, Spania, 36213
- Rekruttering
- Hospital Alvaro Cunqueiro
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Ta kontakt med:
- ROSA MARIA RODRIGUEZ NUÑEZ
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Hovedetterforsker:
- ROSA MARIA RODRIGUEZ NUÑEZ
-
-
Principality of Asturias
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Avilés, Principality of Asturias, Spania, 33401
- Rekruttering
- Hospital Universitario San Agustín
-
Ta kontakt med:
- MARIA ARGÜELLO JUNQUERA
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Hovedetterforsker:
- MARIA ARGÜELLO JUNQUERA
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Oviedo, Principality of Asturias, Spania, 33011
- Rekruttering
- Hospital Universitario Central de Asturias
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Ta kontakt med:
- LUCIA MORAIS
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Hovedetterforsker:
- LUCIA MORAIS
-
-
Salamanca
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Salamanca, Salamanca, Spania, 37007
- Rekruttering
- Hospital Universitario De Salamanca
-
Ta kontakt med:
- ALEJANDRO MARTIN
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Hovedetterforsker:
- ALEJANDRO MARTIN
-
-
Santa Cruz de Tenerife
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San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spania, 38320
- Rekruttering
- Hospital Universitario de Canarias
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Ta kontakt med:
- CAROLINA DE BONIS
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Hovedetterforsker:
- CAROLINA DE BONIS
-
-
Segovia
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Segovia, Segovia, Spania, 40002
- Rekruttering
- Hospital General de Segovia
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Ta kontakt med:
- ANA TORRES
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Hovedetterforsker:
- ANA TORRES
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Sevilla
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Seville, Sevilla, Spania, 41009
- Rekruttering
- Hospital Universitario Virgen Macarena
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Ta kontakt med:
- NAZARET DOMINGUEZ VELASCO
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Hovedetterforsker:
- NAZARET DOMINGUEZ VELASCO
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-
Tarragona
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Tarragona, Tarragona, Spania, 43005
- Rekruttering
- ICO Hospital Universitari Joan XXIII
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Ta kontakt med:
- JORDINA ROVIRA SOLE
-
Hovedetterforsker:
- JORDINA ROVIRA SOLE
-
-
Valencia
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Gandia, Valencia, Spania, 46702
- Rekruttering
- Hospital Francesc de Borja
-
Ta kontakt med:
- ALBERT BLANCO JUAN
-
Hovedetterforsker:
- ALBERT BLANCO JUAN
-
Valencia, Valencia, Spania, 46026
- Rekruttering
- Hospital Universitari i Politecnic La Fe
-
Ta kontakt med:
- SAMUEL ROMERO DOMINGUEZ
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Hovedetterforsker:
- SAMUEL ROMERO DOMINGUEZ
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-Free Survival (PFS)
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Response Rate (ORR) and Complete Response (CR) as Efficacy Outcomes
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. februar 2026
Primær fullføring (Antatt)
1. november 2026
Studiet fullført (Antatt)
1. mai 2027
Datoer for studieregistrering
Først innsendt
27. april 2026
Først innsendt som oppfylte QC-kriteriene
29. mai 2026
Først lagt ut (Faktiske)
3. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Neoplasmer
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Lymfesykdommer
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Lymfom, Non-Hodgkin
- Lymfom
- Lymfom, T-celle
- Hemic og lymfatiske sykdommer
- Lymfom, T-celle, perifert
- Peptider
- Aminosyrer, peptider og proteiner
- Oligopeptider
- Proteiner
- Antistoffer, monoklonalt, humanisert
- Antistoffer, monoklonalt
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serumglobuliner
- Globuliner
- Brentuximab Vedotin
- somatostatin, syklisk heksapeptid(Phe-Phe-Trp-Lys-Thr-Phe)-
Andre studie-ID-numre
- GELTAMO-BVCHP-2021-003
- IISR-2021-200184 (Annen identifikator: Geltamo)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .