CD30-Positive Peripheral T-Cell Lymphoma
Conditions
Keywords
Peripheral T-Cell Lymphoma, CD30, Brentuximab Vedotin, BV-CHP, Real-World Evidence, Observational Study
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.
Interventions
DRUGBrentuximab 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
Sponsors
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Takeda
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) and Complete Response (CR) as Efficacy Outcomes | 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. |
| Overall Survival (OS) | 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. |
| Incidence and Type of Treatment-Related Adverse Events | 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 |
| CD30 Expression at Diagnosis | 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. |
| Treatment Response Assessed by Interim and End-of-Treatment PET/CT | 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 |
| Impact of histological subtype (ALCL vs non-ALCL) on treatment efficacy | 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 |
Countries
Spain
Contacts
CONTACTEva Domingo Domenech, MD
Outcome results
None listed