A Study of Brentuximab Vedotin in Adults With CD30-positive Lymphoma

NCT ID: NCT04837222

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-07

Study Completion Date

2026-06-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is an observational, non-interventional, prospective study in participants with CD30-positive lymphoma who are receiving or will receive the standard treatment of brentuximab vedotin. This study will assess the safety profile and effectiveness of brentuximab vedotin in the real-world clinical practice.

The study will enroll approximately 1000 participants. The data will be collected and recorded in the medical record for the purpose of medical care and also recorded in electronic case report forms (e-CRFs). All the participants will be assigned to a single observational cohort:

• All participants with CD30-positive lymphoma

This multi-center trial will be conducted in China. All participants will be followed up for 24 months unless withdrawal of Informed Consent, lost or death, whichever comes first. The overall duration of the study will be approximately 4 years.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lymphoma

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Drug Therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No Intervention

Intervention Type OTHER

This is a non-interventional study.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No Intervention

This is a non-interventional study.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Undergoing treatment with brentuximab vedotin (of less than 3 months from initial treatment with brentuximab vedotin) or to be received with brentuximab vedotin.
2. CD30-positive lymphoma by INV (any CD30 expression)

Exclusion Criteria

1\. Who currently participates in or with plan to participate in any interventional clinical trial.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Anhui Provincial Cancer Hospital

Hefei, Anhui, China

Site Status

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status

Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status

Peking University Third Hospita

Beijing, Beijing Municipality, China

Site Status

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Site Status

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status

ZhuJiang Hosptital of Southern Medical University

Guangzhou, Guangdong, China

Site Status

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Site Status

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Site Status

HenanProvincial CancerHospital

Zhengzhou, Henan, China

Site Status

Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status

Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

Site Status

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Site Status

Affiliated Hodpital of Nantong University

Nantong, Jiangsu, China

Site Status

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status

The first hospital of Jilin University

Changchun, Jilin, China

Site Status

The Second Hospital of Dalian Medical University

Dalian, Liaoning, China

Site Status

Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status

ShandongProvincial CancerHospital

Jinan, Shandong, China

Site Status

Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status

ShanxiProvincial CancerHospital

Taiyuan, Shanxi, China

Site Status

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Site Status

Hematology Hospital of Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

Site Status

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Site Status

Tianjin People's Hospital

Tianjin, Tianjin Municipality, China

Site Status

Yunnan First People's Hospital

Kunming, Yunnan, China

Site Status

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status

The Affiliated People's Hospital of Ningbo University

Ningbo, Zhejiang, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Related Links

Access external resources that provide additional context or updates about the study.

https://clinicaltrials.takeda.com/study-detail/60749a78688ad8001f42fb91??page=1&idFilter=C25022

Click here for more information about this trial in easy-to-understand language.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

U1111-1258-8445

Identifier Type: REGISTRY

Identifier Source: secondary_id

C25022

Identifier Type: -

Identifier Source: org_study_id