A Study of Brentuximab Vedotin in Adults With CD30-positive Lymphoma
Observational, Non-interventional, Multicenter Study Aimed at Collecting Prospective Data Related to Study Safety and Effectiveness in Real Clinical Practice in Patients With CD30+ Lymphoma (BRAVE Study)
2 other identifiers
observational
1,000
1 country
32
Brief Summary
Participants with CD30-positive lympoma will be treated with brentuximab vedotin according to their clinic's standard practice. The main aim of this study is to collect information on any side effects from treatment with brentuximab vedotin. Other aims are to collect information on how brentuximab vedotin is used to treat these participants and the outcomes of these participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2021
Longer than P75 for all trials
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2021
CompletedFirst Posted
Study publicly available on registry
April 8, 2021
CompletedStudy Start
First participant enrolled
June 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 19, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 19, 2026
December 24, 2025
December 1, 2025
5 years
April 7, 2021
December 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Reporting one or More Serious Adverse Events (SAEs)
Up to 4 years
Secondary Outcomes (13)
Number of Participants Reporting one or More Adverse Events (AEs)
Up to 4 years
Number of Participants Reporting one or More Adverse Drug Reactions (ADRs)
Up to 4 years
Number of Participants With Dose Adjustments During the Study
Up to 4 years
Number of Participants Based on Usage of Brentuximab Vedotin
Up to 4 years
Number of Cycles of Brentuximub Vedotin Administered in Routine Clinical Practice
Up to 4 years
- +8 more secondary outcomes
Study Arms (1)
Participants with CD30-positive Lymphoma
All participants diagnosed with CD30-positive lymphoma who are receiving or will recieve brentuximab vedotin will be observed prospectively over 24-month period, unless withdrawal of informed consent, lost or death, whichever comes first.
Interventions
Eligibility Criteria
Participants with CD30-positive lymphoma, who have been prescribed brentuximab vedotin in clinical practice will be observed prospectively.
You may qualify if:
- Undergoing treatment with brentuximab vedotin (of less than 3 months from initial treatment with brentuximab vedotin) or to be received with brentuximab vedotin.
- CD30-positive lymphoma by INV (any CD30 expression)
You may not qualify if:
- \. Who currently participates in or with plan to participate in any interventional clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (32)
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230001, China
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100010, China
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Peking University Third Hospita
Beijing, Beijing Municipality, 100191, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510280, China
ZhuJiang Hosptital of Southern Medical University
Guangzhou, Guangdong, 510280, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518035, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003, China
HenanProvincial CancerHospital
Zhengzhou, Henan, 450003, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430023, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
Affiliated Hodpital of Nantong University
Nantong, Jiangsu, 226001, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The first hospital of Jilin University
Changchun, Jilin, 130021, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, 116027, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
ShandongProvincial CancerHospital
Jinan, Shandong, 250117, China
Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
ShanxiProvincial CancerHospital
Taiyuan, Shanxi, 030013, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Hematology Hospital of Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060, China
Tianjin People's Hospital
Tianjin, Tianjin Municipality, 300121, China
Yunnan First People's Hospital
Kunming, Yunnan, 650032, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310052, China
The Affiliated People's Hospital of Ningbo University
Ningbo, Zhejiang, 315040, China
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2021
First Posted
April 8, 2021
Study Start
June 7, 2021
Primary Completion (Estimated)
June 19, 2026
Study Completion (Estimated)
June 19, 2026
Last Updated
December 24, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.