Study identification

PURI

https://redirect.ema.europa.eu/resource/44654

EU PAS number

EUPAS44653

Study ID

44654

Official title and acronym

C25023: 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. The BELIEVE Study.

DARWIN EU® study

No

Study countries

Spain

Study description

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 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.

Study status

Finalised
Research institutions and networks

Institutions

Takeda
First published:
01/02/2024
Institution

Contact details

Study Contact Takeda

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Takeda
Study protocol
Initial protocol

Amendment 1_BELIEVE Study Protocol V 2.0 10SEP2021_SIGNED.pdf

English (4.5 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable