ClinicalTrials.gg
RecruitingNCT07624838Updated Jun 3, 2026

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

An observational study in CD30-Positive Peripheral T-Cell Lymphoma, sponsored by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea. Recruiting at 37 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-03.

Sponsored by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea · Observational

From the registry’s dates

  • Started Feb 2026; still recruiting 8 months later.

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 25 studies in Lymphoma, T-Cell, Peripheral with a site in Spain — 5 open to participants now, 8 under way, 2 of them phase 3. Lymphoma, T-Cell, Peripheral · Spain.

Started
2026
with 1 other
Observational
3 of 25
1 open now
Registered
25th of 25
by date

Among the 25 studies in Lymphoma, T-Cell, Peripheral with a site in Spain, this one is one of 2 that started in 2026, is one of 3 observational ones, and was the 25th registered.

Lymphoma, T-Cell, Peripheral

372 studies on the registry are indexed under Lymphoma, T-Cell, Peripheral; 110 are open to participants now.

Browse Lymphoma, T-Cell, Peripheral studies →

Open to participants now

5 of the 25 studies in Lymphoma, T-Cell, Peripheral with a site in Spain are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →

Who these studies take

Of the 76 Lymphoma, T-Cell, Peripheral studies recruiting now, 30 (39%) set no upper age limit and 38 (50%) stop at 75 or younger; 5 take children under 18; none take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 25 studies in Lymphoma, T-Cell, Peripheral with a site in Spain, or all of them as a file.
02

Study summary

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.

03

Conditions studied

  • CD30-Positive Peripheral T-Cell Lymphoma

Keywords

  • Peripheral T-Cell Lymphoma
  • CD30
  • Brentuximab Vedotin
  • BV-CHP
  • Real-World Evidence
  • Observational Study
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 therapy between January 2019 and September 2024

Exclusion criteria

Exclusion Criteria:

  • Patients who have received prior treatment for their lymphoma
  • Patients who have received the combination as part of a clinical trial.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • DrugBrentuximab Vedotin Plus CHP

    Drug page: Brentuximab Vedotin

    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

06

What researchers measure

Primary outcomes

  1. Progression-Free Survival (PFS)

    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

    Time frame: From enrollment until disease progression, relapse, death, or last follow-up, assessed up to approximately 68 months.

Secondary outcomes

  1. Overall Response Rate (ORR) and Complete Response (CR) as Efficacy Outcomes

    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.

    Time frame: During first-line treatment, assessed up to approximately 12 months

  2. Overall Survival (OS)

    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.

    Time frame: From enrollment until disease progression, relapse, death, or last follow-up, assessed up to approximately 68 months.

  3. Incidence and Type of Treatment-Related Adverse Events

    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

    Time frame: During first-line treatment, assessed up to approximately 12 months

  4. CD30 Expression at Diagnosis

    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.

    Time frame: At diagnosis (baseline

  5. Treatment Response Assessed by Interim and End-of-Treatment PET/CT

    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

    Time frame: During first-line treatment, assessed up to approximately 12 months

  6. Impact of histological subtype (ALCL vs non-ALCL) on treatment efficacy

    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

    Time frame: From enrollment until disease progression, relapse, death, or last follow-up, assessed up to approximately 68 months

07

Study locations

37 of 37 sites recruiting
  • Hospital Universitario A Coruña
    A Coruña, A Coruña 15006, Spain
    Recruiting
    • DANIEL GARCIA GARCIA · Contact
    • DANIEL GARCIA GARCIA · Principal investigator
  • Hospital Universitari Son Llàtzer
    Palma de Mallorca, Balearic Islands 07008, Spain
    Recruiting
    • RAQUEL DEL CAMPO · Contact
    • RAQUEL DEL CAMPO · Principal investigator
  • Hospital Universitari Son Espases
    Palma de Mallorca, Balearic Islands 07120, Spain
    Recruiting
    • ANTONIO GUTIERREZ · Contact
    • ANTONIO GUTIERREZ · Principal investigator
  • ICO Hospital Germans Trias i Pujol
    Badalona, Barcelona 08916, Spain
    Recruiting
    • MIREIA FRANCH · Contact
    • MIREIA FRANCH · Principal investigator
  • Hospital del Mar
    Barcelona, Barcelona 08003, Spain
    Recruiting
    • BLANCA SANCHEZ · Contact
    • BLANCA SANCHEZ · Principal investigator
  • Hospital Universitari Vall d'Hebron
    Barcelona, Barcelona 08035, Spain
    Recruiting
    • ANGEL SERNA PAREJA · Contact
    • ANGEL SERNA PAREJA · Principal investigator
  • Hospital Clínic de Barcelona
    Barcelona, Barcelona 08036, Spain
    Recruiting
    • LAURA MAGNANO · Contact
    • LAURA MAGNANO · Principal investigator
  • Hospital de la Santa Creu i Sant Pau
    Barcelona, Barcelona 08041, Spain
    Recruiting
    • ANA MUNTAÑOLA PRAT · Contact
    • ANA MUNTAÑOLA PRAT · Principal investigator
  • ICO Hospital Duran i Reynals
    L'Hospitalet de Llobregat, Barcelona 08908, Spain
    Recruiting
    • EVA DOMINGO DOMENECH · Contact
    • EVA DOMINGO DOMENECH · Principal investigator
  • Hospital Moisès Broggi
    Sant Joan Despí, Barcelona 08970, Spain
    Recruiting
    • ALESSANDRA COMAI · Contact
    • ALESSANDRA COMAI · Principal investigator
  • Hospital Universitario Marqués de Valdecilla
    Santander, Cantabria 39008, Spain
    Recruiting
    • SONIA GONZALEZ DE VILLAMBROSI · Contact
    • SONIA GONZALEZ DE VILLAMBROSI · Principal investigator
  • Hospital Universitario de Jerez
    Jerez de la Frontera, Cádiz 11407, Spain
    Recruiting
    • ROCIO FE BITAUBE · Contact
    • ROCIO FE BITAUBE · Principal investigator
  • Hospital Universitario Donostia
    San Sebastián, Gipuzkoa 20014, Spain
    Recruiting
    • IZASKUN ZEBERIO · Contact
    • IZASKUN ZEBERIO · Principal investigator
  • ICO Girona - Hospital Dr. Josep Trueta
    Girona, Girona 17007, Spain
    Recruiting
    • MARIA CERDÁ SABATER · Contact
    • MARIA CERDÁ SABATER · Principal investigator
  • Hospital Universitario Juan Ramón Jiménez
    Huelva, Huelva 21005, Spain
    Recruiting
    • SOFIA VAZQUEZ · Contact
    • SOFIA VAZQUEZ · Principal investigator
  • Hospital Universitario Doctor Negrín
    Las Palmas de Gran Canaria, Las Palmas 35010, Spain
    Recruiting
    • HARIDIAN DE LA NUEZ MELIAN · Contact
    • HARIDIAN DE LA NUEZ MELIAN · Principal investigator
  • Hospital Universitario Príncipe de Asturias
    Alcalá de Henares, Madrid 28805, Spain
    Recruiting
    • PAOLA VILLAFUERTE GUTIERREZ · Contact
    • PAOLA VILLAFUERTE GUTIERREZ · Principal investigator
  • Hospital del Sureste
    Arganda, Madrid 28500, Spain
    Recruiting
    • TERESA COBO RODRIGUEZ · Contact
    • TERESA COBO RODRIGUEZ · Principal investigator
  • Hospital Universitario Severo Ochoa
    Leganés, Madrid 28911, Spain
    Recruiting
    • MARIA LUISA BENGOCHEA · Contact
    • MARIA LUISA BENGOCHEA · Principal investigator
  • Hospital Universitario de La Princesa
    Madrid, Madrid 28006, Spain
    Recruiting
    • ANA GARCIA NOBLEJAS · Contact
    • ANA GARCIA NOBLEJAS · Principal investigator
  • Hospital Universitario Gregorio Marañón
    Madrid, Madrid 28007, Spain
    Recruiting
    • PAULA FERNANDEZ CALDAS · Contact
    • PAULA FERNANDEZ CALDAS · Principal investigator
  • Hospital Universitario Ramón y Cajal
    Madrid, Madrid 28034, Spain
    Recruiting
    • FERNANDO MARTIN MORO · Contact
    • FERNANDO MARTIN MORO · Principal investigator
  • Hospital Universitario 12 de Octubre
    Madrid, Madrid 28041, Spain
    Recruiting
    • ANTONIA RODRIGUEZ IZQUIERDO · Contact
    • ANTONIA RODRIGUEZ IZQUIERDO · Principal investigator
  • Hospital Universitario Rey Juan Carlos
    Móstoles, Madrid 28933, Spain
    Recruiting
    • GABRIELA SALVATIERRA CALDERON · Contact
    • GABRIELA SALVATIERRA CALDERON · Principal investigator
  • Hospital General Universitario Santa Lucía
    Cartagena, Murcia 30202, Spain
    Recruiting
    • ANA BELEN ARROYO RODRIGUEZ · Contact
    • ANA BELEN ARROYO RODRIGUEZ · Principal investigator
  • Hospital Universitario Morales Meseguer
    Murcia, Murcia 30008, Spain
    Recruiting
    • JOSE JAVIER SANCHEZ BLANCO · Contact
    • JOSE JAVIER SANCHEZ BLANCO · Principal investigator
  • Clínica Universidad de Navarra
    Pamplona, Navarre 31008, Spain
    Recruiting
    • CARLOS GRANDE · Contact
    • CARLOS GRANDE · Principal investigator
  • Hospital Álvaro Cunqueiro
    Vigo, Pontevedra 36213, Spain
    Recruiting
    • ROSA MARIA RODRIGUEZ NUÑEZ · Contact
    • ROSA MARIA RODRIGUEZ NUÑEZ · Principal investigator
  • Hospital Universitario San Agustín
    Avilés, Principality of Asturias 33401, Spain
    Recruiting
    • MARIA ARGÜELLO JUNQUERA · Contact
    • MARIA ARGÜELLO JUNQUERA · Principal investigator
  • Hospital Universitario Central de Asturias
    Oviedo, Principality of Asturias 33011, Spain
    Recruiting
    • LUCIA MORAIS · Contact
    • LUCIA MORAIS · Principal investigator
  • Hospital Universitario de Salamanca
    Salamanca, Salamanca 37007, Spain
    Recruiting
    • ALEJANDRO MARTIN · Contact
    • ALEJANDRO MARTIN · Principal investigator
  • Hospital Universitario de Canarias
    San Cristóbal de La Laguna, Santa Cruz de Tenerife 38320, Spain
    Recruiting
    • CAROLINA DE BONIS · Contact
    • CAROLINA DE BONIS · Principal investigator
  • Hospital General de Segovia
    Segovia, Segovia 40002, Spain
    Recruiting
    • ANA TORRES · Contact
    • ANA TORRES · Principal investigator
  • Hospital Universitario Virgen Macarena
    Seville, Sevilla 41009, Spain
    Recruiting
    • NAZARET DOMINGUEZ VELASCO · Contact
    • NAZARET DOMINGUEZ VELASCO · Principal investigator
  • ICO Hospital Universitari Joan XXIII
    Tarragona, Tarragona 43005, Spain
    Recruiting
    • JORDINA ROVIRA SOLE · Contact
    • JORDINA ROVIRA SOLE · Principal investigator
  • Hospital Francesc de Borja
    Gandia, Valencia 46702, Spain
    Recruiting
    • ALBERT BLANCO JUAN · Contact
    • ALBERT BLANCO JUAN · Principal investigator
  • Hospital Universitari i Politècnic La Fe
    Valencia, Valencia 46026, Spain
    Recruiting
    • SAMUEL ROMERO DOMINGUEZ · Contact
    • SAMUEL ROMERO DOMINGUEZ · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2026 (actual). Primary completion is estimated for Nov 2026, 9 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 27, 2026
First posted
Jun 3, 2026
StartActual
Feb 15, 2026
Primary completionEst.
Nov 2026
CompletionEst.
May 2027
Last update
Jun 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07624838
Lead sponsor
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Collaborators
Takeda
Responsible party
Sponsor
First posted
Jun 3, 2026
Start date
Feb 15, 2026
Primary completion
Nov 2026 (estimated)
Completion
May 2027 (estimated)
Last update
Jun 3, 2026

Study contacts

Eva Domingo Domenech, MD
Contact
edomingo@iconcologia.net
932697750

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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