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

NCT07624838 | Recruiting FDA Drug

• 2 other identifiers: GELTAMO-BVCHP-2021-003IISR-2021-200184
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 37

Brief 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.

Conditions

CD30-Positive Peripheral T-Cell Lymphoma

Keywords

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

Outcome Measures

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

  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

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

• Overall Survival (OS)

  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

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

• CD30 Expression at Diagnosis

  At diagnosis (baseline

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

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

Study Arms (1)

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

Brentuximab Vedotin Plus CHP DRUG

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

BV-CHP First-Line Treatment Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients who have received prior treatment for their lymphoma
• Patients who have received the combination as part of a clinical trial.

Sponsors & Collaborators

• Takeda: collaborator
• Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea: lead

Study Sites (37)

Hospital Universitario A Coruña

A Coruña, A Coruña, 15006, Spain

RECRUITING

Hospital Universitari Son Llàtzer

Palma de Mallorca, Balearic Islands, 07008, Spain

RECRUITING

Hospital Universitari Son Espases

Palma de Mallorca, Balearic Islands, 07120, Spain

RECRUITING

ICO Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

RECRUITING

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

RECRUITING

Hospital Clínic de Barcelona

Barcelona, Barcelona, 08036, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08041, Spain

RECRUITING

ICO Hospital Duran i Reynals

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

RECRUITING

Hospital Moisès Broggi

Sant Joan Despí, Barcelona, 08970, Spain

RECRUITING

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

RECRUITING

Hospital Universitario de Jerez

Jerez de la Frontera, Cádiz, 11407, Spain

RECRUITING

Hospital Universitario Donostia

San Sebastián, Gipuzkoa, 20014, Spain

RECRUITING

ICO Girona - Hospital Dr. Josep Trueta

Girona, Girona, 17007, Spain

RECRUITING

Hospital Universitario Juan Ramón Jiménez

Huelva, Huelva, 21005, Spain

RECRUITING

Hospital Universitario Doctor Negrín

Las Palmas de Gran Canaria, Las Palmas, 35010, Spain

RECRUITING

Hospital Universitario Príncipe de Asturias

Alcalá de Henares, Madrid, 28805, Spain

RECRUITING

Hospital del Sureste

Arganda, Madrid, 28500, Spain

RECRUITING

Hospital Universitario Severo Ochoa

Leganés, Madrid, 28911, Spain

RECRUITING

Hospital Universitario de La Princesa

Madrid, Madrid, 28006, Spain

RECRUITING

Hospital Universitario Gregorio Marañón

Madrid, Madrid, 28007, Spain

RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, Madrid, 28034, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, Madrid, 28041, Spain

RECRUITING

Hospital Universitario Rey Juan Carlos

Móstoles, Madrid, 28933, Spain

RECRUITING

Hospital General Universitario Santa Lucía

Cartagena, Murcia, 30202, Spain

RECRUITING

Hospital Universitario Morales Meseguer

Murcia, Murcia, 30008, Spain

RECRUITING

Clínica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Hospital Álvaro Cunqueiro

Vigo, Pontevedra, 36213, Spain

RECRUITING

Hospital Universitario San Agustín

Avilés, Principality of Asturias, 33401, Spain

RECRUITING

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

RECRUITING

Hospital Universitario de Salamanca

Salamanca, Salamanca, 37007, Spain

RECRUITING

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320, Spain

RECRUITING

Hospital General de Segovia

Segovia, Segovia, 40002, Spain

RECRUITING

Hospital Universitario Virgen Macarena

Seville, Sevilla, 41009, Spain

RECRUITING

ICO Hospital Universitari Joan XXIII

Tarragona, Tarragona, 43005, Spain

RECRUITING

Hospital Francesc de Borja

Gandia, Valencia, 46702, Spain

RECRUITING

Hospital Universitari i Politècnic La Fe

Valencia, Valencia, 46026, Spain

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

Brentuximab Vedotin; somatostatin, cyclic hexapeptide(Phe-Phe-Trp-Lys-Thr-Phe)-

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Central Study Contacts

Eva Domingo Domenech, MD

CONTACT

932697750; edomingo@iconcologia.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: June 3, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-05

Locations

ES (37)