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

Hodgkin Disease Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04998331
Study type Observational
Source Takeda
Contact
Status Active, not recruiting
Phase
Start date October 29, 2021
Completion date June 30, 2024
View Details
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