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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
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.
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).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Hospital General Vega Baja
San Bartolomé, Alicante, Spain
Hospital Universitario de Alava
Vitoria-Gasteiz, Araba, Spain
Ico Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Galdakao
Galdakao, Bizkaia, Spain
Hospital Universitario Donostia
Donostia / San Sebastian, Gipuzkoa, Spain
Hospital Universitario Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria, Gran Canarias, Spain
Hospital Universitario Son Espases
Palma de Mallorca, Mallorca, Spain
Hospital Clinico Universitario Salamanca
Salamanca, Salamnaca, Spain
Hospital Nuestra Senora de Candelaria
Santa Cruz de Tenerife, Tenerife, Spain
Hospital Del Mar
Barcelona, Spain
Start Date
October 29, 2021
Primary Completion Date
April 30, 2022
Completion Date
September 7, 2023
Last Updated
September 19, 2024
51
ACTUAL participants
No Intervention
OTHER
Lead Sponsor
Takeda
NCT07209059
NCT02287311
Data Source & Attribution
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