CD30-Positive Peripheral T-Cell LymphomaNCT07624838
Real-life Experience of Brentuximab Vedotin Plus CHP as First-line Treatment of CD30+ Peripheral T-cell Lymphomas in Spain
An observational study of CD30-Positive Peripheral T-Cell Lymphoma, run by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea at 37 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CD30-Positive Peripheral T-Cell Lymphoma
- What is being tested?
- Brentuximab Vedotin Plus CHP
- How many people
- 100 participants
- Where
- 37 sitesSpain
- Study dates
- 15 Feb 2026to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients who have received prior treatment for their lymphoma
- Patients who have received the combination as part of a clinical trial.
Trial locations and contacts
37 sites in 1 country. Contact the study team or a site near you to ask about taking part.
37 sites in 1 country
Spain37 sites, 37 recruiting
- Recruiting
Hospital Universitario A Coruña
A Coruña, A Coruña, 15006
DANIEL GARCIA GARCIA
DANIEL GARCIA GARCIA
- Recruiting
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Madrid, 28805
PAOLA VILLAFUERTE GUTIERREZ
PAOLA VILLAFUERTE GUTIERREZ
- Recruiting
Hospital del Sureste
Arganda, Madrid, 28500
TERESA COBO RODRIGUEZ
TERESA COBO RODRIGUEZ
- Recruiting
Hospital Universitario San Agustín
Avilés, Principality of Asturias, 33401
MARIA ARGÜELLO JUNQUERA
MARIA ARGÜELLO JUNQUERA
- Recruiting
ICO Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
MIREIA FRANCH
MIREIA FRANCH
- Recruiting
Hospital del Mar
Barcelona, Barcelona, 08003
BLANCA SANCHEZ
BLANCA SANCHEZ
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, 08035
ANGEL SERNA PAREJA
ANGEL SERNA PAREJA
- Recruiting
Hospital Clínic de Barcelona
Barcelona, Barcelona, 08036
LAURA MAGNANO
LAURA MAGNANO
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08041
ANA MUNTAÑOLA PRAT
ANA MUNTAÑOLA PRAT
- Recruiting
Hospital General Universitario Santa Lucía
Cartagena, Murcia, 30202
ANA BELEN ARROYO RODRIGUEZ
ANA BELEN ARROYO RODRIGUEZ
- Recruiting
Hospital Francesc de Borja
Gandia, Valencia, 46702
ALBERT BLANCO JUAN
ALBERT BLANCO JUAN
- Recruiting
ICO Girona - Hospital Dr. Josep Trueta
Girona, Girona, 17007
MARIA CERDÁ SABATER
MARIA CERDÁ SABATER
- Recruiting
Hospital Universitario Juan Ramón Jiménez
Huelva, Huelva, 21005
SOFIA VAZQUEZ
SOFIA VAZQUEZ
- Recruiting
Hospital Universitario de Jerez
Jerez de la Frontera, Cádiz, 11407
ROCIO FE BITAUBE
ROCIO FE BITAUBE
- Recruiting
ICO Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, 08908
EVA DOMINGO DOMENECH
EVA DOMINGO DOMENECH
- Recruiting
Hospital Universitario Doctor Negrín
Las Palmas de Gran Canaria, Las Palmas, 35010
HARIDIAN DE LA NUEZ MELIAN
HARIDIAN DE LA NUEZ MELIAN
- Recruiting
Hospital Universitario Severo Ochoa
Leganés, Madrid, 28911
MARIA LUISA BENGOCHEA
MARIA LUISA BENGOCHEA
- Recruiting
Hospital Universitario de La Princesa
Madrid, Madrid, 28006
ANA GARCIA NOBLEJAS
ANA GARCIA NOBLEJAS
- Recruiting
Hospital Universitario Gregorio Marañón
Madrid, Madrid, 28007
PAULA FERNANDEZ CALDAS
PAULA FERNANDEZ CALDAS
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, Madrid, 28034
FERNANDO MARTIN MORO
FERNANDO MARTIN MORO
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
ANTONIA RODRIGUEZ IZQUIERDO
ANTONIA RODRIGUEZ IZQUIERDO
- Recruiting
Hospital Universitario Rey Juan Carlos
Móstoles, Madrid, 28933
GABRIELA SALVATIERRA CALDERON
GABRIELA SALVATIERRA CALDERON
- Recruiting
Hospital Universitario Morales Meseguer
Murcia, Murcia, 30008
JOSE JAVIER SANCHEZ BLANCO
JOSE JAVIER SANCHEZ BLANCO
- Recruiting
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
LUCIA MORAIS
LUCIA MORAIS
- Recruiting
Hospital Universitari Son Llàtzer
Palma de Mallorca, Balearic Islands, 07008
RAQUEL DEL CAMPO
RAQUEL DEL CAMPO
- Recruiting
Hospital Universitari Son Espases
Palma de Mallorca, Balearic Islands, 07120
ANTONIO GUTIERREZ
ANTONIO GUTIERREZ
- Recruiting
Clínica Universidad de Navarra
Pamplona, Navarre, 31008
CARLOS GRANDE
CARLOS GRANDE
- Recruiting
Hospital Universitario de Salamanca
Salamanca, Salamanca, 37007
ALEJANDRO MARTIN
ALEJANDRO MARTIN
- Recruiting
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320
CAROLINA DE BONIS
CAROLINA DE BONIS
- Recruiting
Hospital Universitario Donostia
San Sebastián, Gipuzkoa, 20014
IZASKUN ZEBERIO
IZASKUN ZEBERIO
- Recruiting
Hospital Moisès Broggi
Sant Joan Despí, Barcelona, 08970
ALESSANDRA COMAI
ALESSANDRA COMAI
- Recruiting
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
SONIA GONZALEZ DE VILLAMBROSI
SONIA GONZALEZ DE VILLAMBROSI
- Recruiting
Hospital General de Segovia
Segovia, Segovia, 40002
ANA TORRES
ANA TORRES
- Recruiting
Hospital Universitario Virgen Macarena
Seville, Sevilla, 41009
NAZARET DOMINGUEZ VELASCO
NAZARET DOMINGUEZ VELASCO
- Recruiting
ICO Hospital Universitari Joan XXIII
Tarragona, Tarragona, 43005
JORDINA ROVIRA SOLE
JORDINA ROVIRA SOLE
- Recruiting
Hospital Universitari i Politècnic La Fe
Valencia, Valencia, 46026
SAMUEL ROMERO DOMINGUEZ
SAMUEL ROMERO DOMINGUEZ
- Recruiting
Hospital Álvaro Cunqueiro
Vigo, Pontevedra, 36213
ROSA MARIA RODRIGUEZ NUÑEZ
ROSA MARIA RODRIGUEZ NUÑEZ
About this study
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:
Read more
- 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.
- Conditions
- CD30-Positive Peripheral T-Cell Lymphoma
- Being tested
- Brentuximab Vedotin Plus CHP
- Keywords
- Peripheral T-Cell Lymphoma, CD30, Brentuximab Vedotin, BV-CHP, Real-World Evidence, Observational Study
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brentuximab Vedotin Plus CHPDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Brentuximab Vedotin Plus CHP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment until disease progression, relapse, death, or last follow-up, assessed up to approximately 68 months.
Secondary outcomes (6)
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.
Measured: During first-line treatment, assessed up to approximately 12 months
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.
Measured: 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
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
Measured: During first-line treatment, assessed up to approximately 12 months
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.
Measured: At diagnosis (baseline
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
Measured: During first-line treatment, assessed up to approximately 12 months
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
Measured: From enrollment until disease progression, relapse, death, or last follow-up, assessed up to approximately 68 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start15 Feb 2026
- Primary completionNov 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CD30-Positive Peripheral T-Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07624838
- Sponsor's protocol ID
- GELTAMO-BVCHP-2021-003
- Other IDs
- IISR-2021-200184
- Status last verified
- May 2026
- First submitted
- 27 Apr 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-life Experience of Brentuximab Vedotin Plus CHP as First-line Treatment of CD30+ Peripheral T-cell Lymphomas in Spain
- ClinicalTrials.gov ID
- NCT07624838
- Acronym / sponsor ID
- GELTAMO-BVCHP-2021-003
- Conditions
- CD30-Positive Peripheral T-Cell Lymphoma
- Keywords
- Peripheral T-Cell Lymphoma, CD30, Brentuximab Vedotin, BV-CHP, Real-World Evidence, Observational Study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Grupo Español de Linfomas y Transplante Autólogo de Médula ÓseaUniversity, hospital or other
- Collaborators
- Takeda
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BV-CHP First-Line Treatment Cohort | – | Drug: Brentuximab Vedotin Plus CHPThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who have received prior treatment for their lymphoma
- Patients who have received the combination as part of a clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brentuximab Vedotin Plus CHPBrentuximab 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 | Drug | BV-CHP First-Line Treatment Cohort |
Primary outcome
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
6 secondary outcomes
Overall Response Rate (ORR) and Complete Response (CR) as Efficacy Outcomes
Time frame: 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.
Incidence and Type of Treatment-Related Adverse Events
Time frame: During first-line treatment, assessed up to approximately 12 months
CD30 Expression at Diagnosis
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
Related trials for CD30-Positive Peripheral T-Cell Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 1
Allogeneic CD30.CAR-EBVSTs in Patients With Relapsed or Refractory CD30-Positive Lymphomas
Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type, Classical Hodgkin Lymphoma
RecruitingPhase 1
Constitutive IL7R (C7R) Modified Banked Allogeneic CD30.CAR EBVSTS for CD30-Positive Lymphomas
CD30-Positive Diffuse Large B-Cell Lymphoma, Anaplastic Large Cell Lymphoma, T Cell and Null Cell Type
Not yet recruitingPhase 1
Autologous IC-Nine, CD30 CAR, and Constitutive IL7R Expressing EBVST for CD30 Lymphoma (ANCILE-30)
Diffuse Large B-Cell Lymphoma (DLBCL), Hodgkin Lymphoma
Not yet recruitingPhase 2
Efficacy and Safety of Brentuximab Vedotin Combined With Lisaftoclax in CD30+ Cutaneous T-cell Lymphoma (CTCL)
Cutaneous T-Cell Lymphoma/Mycosis Fungoides, Primary Cutaneous Anaplastic Large Cell Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CD30-Positive Peripheral T-Cell Lymphoma, run by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea at 37 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eva Domingo Domenech, MD (932697750, edomingo@iconcologia.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: From enrollment until disease progression, relapse, death, or last follow-up, assessed up to approximately 68 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.