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

May 29, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: 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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR) and Complete Response (CR) as Efficacy Outcomes
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Collaborators

Takeda

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

April 27, 2026

First Submitted That Met QC Criteria

May 29, 2026

First Posted (Actual)

June 3, 2026

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GELTAMO-BVCHP-2021-003
  • IISR-2021-200184 (Other Identifier: Geltamo)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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