NCT04998331

A Spanish Medical Record Review of Adults With Relapsed or Refractory CD30+ Malignancies When Re-treated With Brentuximab-vedotin

Effectiveness and Safety for Re-treatment With Brentuximab-Vedotin (BV) in Patients With Relapsed/Refractory (R/R) CD30+ Malignancies: a Retrospective Medical Chart Review Study in Spain

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 51 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Participants in the study are adults with CD30-positive malignancies which include classical Hodgkin lymphoma (cHL), cutaneous T-cell lymphoma (CTCL): mycosis fungoides (MF) or primarily cutaneous anaplastic large cell lymphoma (pcALCL), or systemic anaplastic large cell lymphoma (sALCL). The main aims of the study are as follows: * to learn about the response rates of participants with relapsed or refractory CD30+ malignancies when re-treated with BV. * to check for side effects from re-treatment with BV. The study will take place in approximately 30 hospitals in Spain. The study doctors will review each participant's medical record at least 6 months after finishing the last dose of re-treatment with BV. This study is about collecting existing information only; participants will not receive treatment or need to visit a study doctor during this study.

Detailed description

This is an observational, non-interventional, retrospective study in participants with R/R CD30 positive cHL, CTCL (MF and pcALCL) and sALCL who have previously achieved a CR or PR with BV treatment and subsequently experienced disease progression were administered BV retreatment. This study will assess the effectiveness and safety of BV retreatment in the Spanish population in real-world clinical practice. The study will enroll approximately 35 participants. The data will be collected and recorded from the medical record of participants and also recorded in electronic case report forms (e-CRFs). All the participants will be assigned to a single observational cohort: • Participants With CD30-positive Lymphoma This multi-center trial will be conducted in Spain. The overall duration of the study will be approximately 24 months (12 months for medical chart review and 12 until publication submission).

Conditions

• Hodgkin Disease
• Lymphoma, T-Cell, Cutaneous

Interventions

Type	Name	Description
OTHER	No Intervention	This is a non-interventional study.

Timeline

• Start date: 2021-10-29
• Primary completion: 2022-04-30
• Completion: 2023-09-07
• First posted: 2021-08-10
• Last updated: 2024-09-19

Locations

30 sites across 1 country: Spain

Regulatory

• FDA-regulated drug study