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

29. maj 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

100

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Spanien
    • A Coruña
      • A Coruña, A Coruña, Spanien, 15006
        • Rekruttering
        • Hospital Universitario A Coruna
        • Kontakt:
          • DANIEL GARCIA GARCIA
        • Ledende efterforsker:
          • DANIEL GARCIA GARCIA
    • Balearic Islands
      • Palma de Mallorca, Balearic Islands, Spanien, 07008
        • Rekruttering
        • Hospital Universitari Son Llàtzer
        • Kontakt:
          • RAQUEL DEL CAMPO
        • Ledende efterforsker:
          • RAQUEL DEL CAMPO
      • Palma de Mallorca, Balearic Islands, Spanien, 07120
        • Rekruttering
        • Hospital Universitari Son Espases
        • Ledende efterforsker:
          • ANTONIO GUTIERREZ
        • Kontakt:
          • ANTONIO GUTIERREZ
    • Barcelona
      • Badalona, Barcelona, Spanien, 08916
        • Rekruttering
        • ICO Hospital Germans Trias i Pujol
        • Kontakt:
          • MIREIA FRANCH
        • Ledende efterforsker:
          • MIREIA FRANCH
      • Barcelona, Barcelona, Spanien, 08036
        • Rekruttering
        • Hospital Clinic De Barcelona
        • Kontakt:
          • LAURA MAGNANO
        • Ledende efterforsker:
          • LAURA MAGNANO
      • Barcelona, Barcelona, Spanien, 08003
        • Rekruttering
        • Hospital del Mar
        • Kontakt:
          • BLANCA SANCHEZ
        • Ledende efterforsker:
          • BLANCA SANCHEZ
      • Barcelona, Barcelona, Spanien, 08035
        • Rekruttering
        • Hospital Universitari Vall d'Hebron
        • Kontakt:
          • ANGEL SERNA PAREJA
        • Ledende efterforsker:
          • ANGEL SERNA PAREJA
      • Barcelona, Barcelona, Spanien, 08041
        • Rekruttering
        • Hospital De La Santa Creu I Sant Pau
        • Ledende efterforsker:
          • ANA MUNTAÑOLA PRAT
        • Kontakt:
          • ANA MUNTAÑOLA PRAT
      • L'Hospitalet de Llobregat, Barcelona, Spanien, 08908
        • Rekruttering
        • ICO Hospital Duran i Reynals
        • Ledende efterforsker:
          • EVA DOMINGO DOMENECH
        • Kontakt:
          • EVA DOMINGO DOMENECH
      • Sant Joan Despí, Barcelona, Spanien, 08970
        • Rekruttering
        • Hospital Moisès Broggi
        • Kontakt:
          • ALESSANDRA COMAI
        • Ledende efterforsker:
          • ALESSANDRA COMAI
    • Cantabria
      • Santander, Cantabria, Spanien, 39008
        • Rekruttering
        • Hospital Universitario Marques de Valdecilla
        • Kontakt:
          • SONIA GONZALEZ DE VILLAMBROSI
        • Ledende efterforsker:
          • SONIA GONZALEZ DE VILLAMBROSI
    • Cádiz
      • Jerez de la Frontera, Cádiz, Spanien, 11407
        • Rekruttering
        • Hospital Universitario de Jerez
        • Kontakt:
          • ROCIO FE BITAUBE
        • Ledende efterforsker:
          • ROCIO FE BITAUBE
    • Gipuzkoa
      • San Sebastián, Gipuzkoa, Spanien, 20014
        • Rekruttering
        • Hospital Universitario Donostia
        • Kontakt:
          • IZASKUN ZEBERIO
        • Ledende efterforsker:
          • IZASKUN ZEBERIO
    • Girona
      • Girona, Girona, Spanien, 17007
        • Rekruttering
        • ICO Girona - Hospital Dr. Josep Trueta
        • Kontakt:
          • MARIA CERDÁ SABATER
        • Ledende efterforsker:
          • MARIA CERDÁ SABATER
    • Huelva
      • Huelva, Huelva, Spanien, 21005
        • Rekruttering
        • Hospital Universitario Juan Ramón Jiménez
        • Kontakt:
          • SOFIA VAZQUEZ
        • Ledende efterforsker:
          • SOFIA VAZQUEZ
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spanien, 35010
        • Rekruttering
        • Hospital Universitario Doctor Negrín
        • Kontakt:
          • HARIDIAN DE LA NUEZ MELIAN
        • Ledende efterforsker:
          • HARIDIAN DE LA NUEZ MELIAN
    • Madrid
      • Alcalá de Henares, Madrid, Spanien, 28805
        • Rekruttering
        • Hospital Universitario Príncipe de Asturias
        • Kontakt:
          • PAOLA VILLAFUERTE GUTIERREZ
        • Ledende efterforsker:
          • PAOLA VILLAFUERTE GUTIERREZ
      • Arganda, Madrid, Spanien, 28500
        • Rekruttering
        • Hospital del Sureste
        • Kontakt:
          • TERESA COBO RODRIGUEZ
        • Ledende efterforsker:
          • TERESA COBO RODRIGUEZ
      • Leganés, Madrid, Spanien, 28911
        • Rekruttering
        • Hospital Universitario Severo Ochoa
        • Kontakt:
          • MARIA LUISA BENGOCHEA
        • Ledende efterforsker:
          • MARIA LUISA BENGOCHEA
      • Madrid, Madrid, Spanien, 28034
        • Rekruttering
        • Hospital Universitario Ramon y Cajal
        • Kontakt:
          • FERNANDO MARTIN MORO
        • Ledende efterforsker:
          • FERNANDO MARTIN MORO
      • Madrid, Madrid, Spanien, 28041
        • Rekruttering
        • Hospital Universitario 12 de Octubre
        • Ledende efterforsker:
          • ANTONIA RODRIGUEZ IZQUIERDO
        • Kontakt:
          • ANTONIA RODRIGUEZ IZQUIERDO
      • Madrid, Madrid, Spanien, 28006
        • Rekruttering
        • Hospital Universitario de La Princesa
        • Kontakt:
          • ANA GARCIA NOBLEJAS
        • Ledende efterforsker:
          • ANA GARCIA NOBLEJAS
      • Madrid, Madrid, Spanien, 28007
        • Rekruttering
        • Hospital Universitario Gregorio Maranon
        • Kontakt:
          • PAULA FERNANDEZ CALDAS
        • Ledende efterforsker:
          • PAULA FERNANDEZ CALDAS
      • Móstoles, Madrid, Spanien, 28933
        • Rekruttering
        • Hospital Universitario Rey Juan Carlos
        • Kontakt:
          • GABRIELA SALVATIERRA CALDERON
        • Ledende efterforsker:
          • GABRIELA SALVATIERRA CALDERON
    • Murcia
      • Cartagena, Murcia, Spanien, 30202
        • Rekruttering
        • Hospital General Universitario Santa Lucía
        • Kontakt:
          • ANA BELEN ARROYO RODRIGUEZ
        • Ledende efterforsker:
          • ANA BELEN ARROYO RODRIGUEZ
      • Murcia, Murcia, Spanien, 30008
        • Rekruttering
        • Hospital Universitario Morales Meseguer
        • Kontakt:
          • JOSE JAVIER SANCHEZ BLANCO
        • Ledende efterforsker:
          • JOSE JAVIER SANCHEZ BLANCO
    • Navarre
      • Pamplona, Navarre, Spanien, 31008
        • Rekruttering
        • Clinica Universidad de Navarra
        • Kontakt:
          • CARLOS GRANDE
        • Ledende efterforsker:
          • CARLOS GRANDE
    • Pontevedra
      • Vigo, Pontevedra, Spanien, 36213
        • Rekruttering
        • Hospital Álvaro Cunqueiro
        • Kontakt:
          • ROSA MARIA RODRIGUEZ NUÑEZ
        • Ledende efterforsker:
          • ROSA MARIA RODRIGUEZ NUÑEZ
    • Principality of Asturias
      • Avilés, Principality of Asturias, Spanien, 33401
        • Rekruttering
        • Hospital Universitario San Agustín
        • Kontakt:
          • MARIA ARGÜELLO JUNQUERA
        • Ledende efterforsker:
          • MARIA ARGÜELLO JUNQUERA
      • Oviedo, Principality of Asturias, Spanien, 33011
        • Rekruttering
        • Hospital Universitario Central de Asturias
        • Kontakt:
          • LUCIA MORAIS
        • Ledende efterforsker:
          • LUCIA MORAIS
    • Salamanca
      • Salamanca, Salamanca, Spanien, 37007
        • Rekruttering
        • Hospital Universitario de Salamanca
        • Kontakt:
          • ALEJANDRO MARTIN
        • Ledende efterforsker:
          • ALEJANDRO MARTIN
    • Santa Cruz de Tenerife
      • San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spanien, 38320
        • Rekruttering
        • Hospital Universitario de Canarias
        • Kontakt:
          • CAROLINA DE BONIS
        • Ledende efterforsker:
          • CAROLINA DE BONIS
    • Segovia
      • Segovia, Segovia, Spanien, 40002
        • Rekruttering
        • Hospital General de Segovia
        • Kontakt:
          • ANA TORRES
        • Ledende efterforsker:
          • ANA TORRES
    • Sevilla
      • Seville, Sevilla, Spanien, 41009
        • Rekruttering
        • Hospital Universitario Virgen Macarena
        • Kontakt:
          • NAZARET DOMINGUEZ VELASCO
        • Ledende efterforsker:
          • NAZARET DOMINGUEZ VELASCO
    • Tarragona
      • Tarragona, Tarragona, Spanien, 43005
        • Rekruttering
        • ICO Hospital Universitari Joan XXIII
        • Kontakt:
          • JORDINA ROVIRA SOLE
        • Ledende efterforsker:
          • JORDINA ROVIRA SOLE
    • Valencia
      • Gandia, Valencia, Spanien, 46702
        • Rekruttering
        • Hospital Francesc de Borja
        • Kontakt:
          • ALBERT BLANCO JUAN
        • Ledende efterforsker:
          • ALBERT BLANCO JUAN
      • Valencia, Valencia, Spanien, 46026
        • Rekruttering
        • Hospital Universitari i Politecnic La Fe
        • Kontakt:
          • SAMUEL ROMERO DOMINGUEZ
        • Ledende efterforsker:
          • SAMUEL ROMERO DOMINGUEZ

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / 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.
Medicin: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Samarbejdspartnere

Takeda

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. februar 2026

Primær færdiggørelse (Anslået)

1. november 2026

Studieafslutning (Anslået)

1. maj 2027

Datoer for studieregistrering

Først indsendt

27. april 2026

Først indsendt, der opfyldte QC-kriterier

29. maj 2026

Først opslået (Faktiske)

3. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GELTAMO-BVCHP-2021-003
  • IISR-2021-200184 (Anden identifikator: Geltamo)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med CD30-Positive Peripheral T-Cell Lymphoma

Kliniske forsøg med Brentuximab Vedotin Plus CHP

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