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| ID | Type | Description | Link |
|---|---|---|---|
| IISR-2021-200184 | Other Identifier | Geltamo |
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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During first-line treatment, assessed up to approximately 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eva Domingo Domenech, MD | Contact | 932697750 | edomingo@iconcologia.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario A Coruña | Recruiting | A Coruña | A Coruña | 15006 | Spain |
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| 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. | 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 | 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. | 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 | 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 | From enrollment until disease progression, relapse, death, or last follow-up, assessed up to approximately 68 months |
| Hospital Universitari Son Llàtzer | Recruiting | Palma de Mallorca | Balearic Islands | 07008 | Spain |
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| Hospital Universitari Son Espases | Recruiting | Palma de Mallorca | Balearic Islands | 07120 | Spain |
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| ICO Hospital Germans Trias i Pujol | Recruiting | Badalona | Barcelona | 08916 | Spain |
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| Hospital del Mar | Recruiting | Barcelona | Barcelona | 08003 | Spain |
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| Hospital Universitari Vall d'Hebron | Recruiting | Barcelona | Barcelona | 08035 | Spain |
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| Hospital Clínic de Barcelona | Recruiting | Barcelona | Barcelona | 08036 | Spain |
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| Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | Barcelona | 08041 | Spain |
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| ICO Hospital Duran i Reynals | Recruiting | L'Hospitalet de Llobregat | Barcelona | 08908 | Spain |
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| Hospital Moisès Broggi | Recruiting | Sant Joan Despí | Barcelona | 08970 | Spain |
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| Hospital Universitario Marqués de Valdecilla | Recruiting | Santander | Cantabria | 39008 | Spain |
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| Hospital Universitario de Jerez | Recruiting | Jerez de la Frontera | Cádiz | 11407 | Spain |
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| Hospital Universitario Donostia | Recruiting | San Sebastián | Gipuzkoa | 20014 | Spain |
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| ICO Girona - Hospital Dr. Josep Trueta | Recruiting | Girona | Girona | 17007 | Spain |
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| Hospital Universitario Juan Ramón Jiménez | Recruiting | Huelva | Huelva | 21005 | Spain |
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| Hospital Universitario Doctor Negrín | Recruiting | Las Palmas de Gran Canaria | Las Palmas | 35010 | Spain |
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| Hospital Universitario Príncipe de Asturias | Recruiting | Alcalá de Henares | Madrid | 28805 | Spain |
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| Hospital del Sureste | Recruiting | Arganda | Madrid | 28500 | Spain |
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| Hospital Universitario Severo Ochoa | Recruiting | Leganés | Madrid | 28911 | Spain |
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| Hospital Universitario de La Princesa | Recruiting | Madrid | Madrid | 28006 | Spain |
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| Hospital Universitario Gregorio Marañón | Recruiting | Madrid | Madrid | 28007 | Spain |
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| Hospital Universitario Ramón y Cajal | Recruiting | Madrid | Madrid | 28034 | Spain |
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| Hospital Universitario 12 de Octubre | Recruiting | Madrid | Madrid | 28041 | Spain |
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| Hospital Universitario Rey Juan Carlos | Recruiting | Móstoles | Madrid | 28933 | Spain |
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| Hospital General Universitario Santa Lucía | Recruiting | Cartagena | Murcia | 30202 | Spain |
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| Hospital Universitario Morales Meseguer | Recruiting | Murcia | Murcia | 30008 | Spain |
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| Clínica Universidad de Navarra | Recruiting | Pamplona | Navarre | 31008 | Spain |
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| Hospital Álvaro Cunqueiro | Recruiting | Vigo | Pontevedra | 36213 | Spain |
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| Hospital Universitario San Agustín | Recruiting | Avilés | Principality of Asturias | 33401 | Spain |
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| Hospital Universitario Central de Asturias | Recruiting | Oviedo | Principality of Asturias | 33011 | Spain |
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| Hospital Universitario de Salamanca | Recruiting | Salamanca | Salamanca | 37007 | Spain |
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| Hospital Universitario de Canarias | Recruiting | San Cristóbal de La Laguna | Santa Cruz de Tenerife | 38320 | Spain |
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| Hospital General de Segovia | Recruiting | Segovia | Segovia | 40002 | Spain |
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| Hospital Universitario Virgen Macarena | Recruiting | Seville | Sevilla | 41009 | Spain |
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| ICO Hospital Universitari Joan XXIII | Recruiting | Tarragona | Tarragona | 43005 | Spain |
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| Hospital Francesc de Borja | Recruiting | Gandia | Valencia | 46702 | Spain |
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| Hospital Universitari i Politècnic La Fe | Recruiting | Valencia | Valencia | 46026 | Spain |
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| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000079963 | Brentuximab Vedotin |
| C043819 | somatostatin, cyclic hexapeptide(Phe-Phe-Trp-Lys-Thr-Phe)- |
| ID | Term |
|---|---|
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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