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LymphomaNCT04837222

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

An observational study of Lymphoma, run by Takeda at 32 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
How many people
1,000 participants
Where
32 sitesChina
Study dates
7 Jun 2021to 26 Jun 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants with CD30-positive lymphoma, who have been prescribed brentuximab vedotin in clinical practice will be observed prospectively.

Who may be able to join

  • 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)

Who cannot join

  • 1. Who currently participates in or with plan to participate in any interventional clinical trial.

Trial locations and contacts

32 sites in 1 country.

32 sites in 1 country

China32 sites

  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100010

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

  • Peking University Third Hospita

    Beijing, Beijing Municipality, 100191

  • The first hospital of Jilin University

    Changchun, Jilin, 130021

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

  • The Second Hospital of Dalian Medical University

    Dalian, Liaoning, 116027

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510280

  • ZhuJiang Hosptital of Southern Medical University

    Guangzhou, Guangdong, 510280

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310052

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui, 230001

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

  • ShandongProvincial CancerHospital

    Jinan, Shandong, 250117

  • Yunnan First People's Hospital

    Kunming, Yunnan, 650032

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, 471003

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu, 210009

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • Affiliated Hodpital of Nantong University

    Nantong, Jiangsu, 226001

  • The Affiliated People's Hospital of Ningbo University

    Ningbo, Zhejiang, 315040

  • Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518035

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050011

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

  • ShanxiProvincial CancerHospital

    Taiyuan, Shanxi, 030013

  • Hematology Hospital of Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality, 300020

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300060

  • Tianjin People's Hospital

    Tianjin, Tianjin Municipality, 300121

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

    Wuhan, Hubei, 430022

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

    Wuhan, Hubei, 430023

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

  • HenanProvincial CancerHospital

    Zhengzhou, Henan, 450003

Other trials in China

About this study

Official title: 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)

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.

Read the detailed description

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
Lymphoma
Being tested
No Intervention
Keywords
Drug Therapy
Medical subject headings
Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No InterventionOther

    This is a non-interventional study.

Study groups in NCT04837222
Study groupRoleWhat they receive
Participants with CD30-positive LymphomaAll 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.
Receives: Other: No Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Reporting one or More Serious Adverse Events (SAEs)

    Measured: Up to 4 years

Secondary outcomes (13)

  1. Number of Participants Reporting one or More Adverse Events (AEs)

    Measured: Up to 4 years

  2. Number of Participants Reporting one or More Adverse Drug Reactions (ADRs)

    ADRs refers to AE related to administered drug.

    Measured: Up to 4 years

  3. Number of Participants With Dose Adjustments During the Study

    Measured: Up to 4 years

  4. Number of Participants Based on Usage of Brentuximab Vedotin

    Measured: Up to 4 years

  5. Number of Cycles of Brentuximub Vedotin Administered in Routine Clinical Practice

    Measured: Up to 4 years

  6. Number of Participants Based on Disease Characteristics

    Number of participants will be reported based on the type of lymphoma, stage, lines of therapy.

    Measured: Up to 4 years

  7. Time to Next Treatment (TTNT)

    TTNT is defined as time between start of each line of a therapy to the next line of therapy.

    Measured: From start of each line of therapy until next line of therapy (up to 4 years)

  8. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants with complete response (CR) and partial response (PR) after treatment in the total number of assessable cases.

    Measured: Up to 4 years

  9. Duration of Response (DOR)

    DOR is calculated from the time of documentation of a CR to documentation of disease progression. CR is defined as disappearance of all residual disease and tumor lesions. Disease progression (PD) is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

    Measured: From date of first documented CR until PD (up to 4 years)

  10. Progression Free Survival (PFS) Rate

    PFS rate is calculated as the percentage of participants who reported PFS (at 1st year, 2nd year) as per investigator's assessment after brentuximab vedotin treatment.

    Measured: 1 year and 2 years

  11. Overall Survival (OS) Rate

    OS rate is measured as the percentage of participants who reported death (at 1st year, 2nd year) after brentuximab vedotin treatment.

    Measured: 1 year and 2 years

  12. Change From Baseline in Quality of Life (QoL) Assessed Using Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Questionnaire Version 4

    The FACT-Lym questionnaire is a validated instrument for assessing the impact of lymphoma on health related quality of life and contains 42 questions covering health related quality of life, common lymphoma symptoms, and treatment side-effects. It contains four core subscales including: Physical Wellbeing, Social/Family Wellbeing, Emotional Wellbeing, and Functional Wellbeing. All questions are answered on a 5-point likert scale ranging from 0 to 4: 0=not at all,1=a little bit, 2=somewhat, 3=quite a bit, 4=very much. Higher scores are associated with a better quality of life.

    Measured: Up to 4 years

  13. Cost-effectiveness Ratio

    Cost-effectiveness ratio will be assessed by the direct cost (including medication, injunction, test, nursing fee, etc.) under brentuximab vedotin treatment divided by the total percent of CR and PR.

    Measured: Up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2021
  2. Study start7 Jun 2021
  3. Primary completion26 Jun 2026
  4. Study completion26 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04837222
Sponsor's protocol ID
C25022
Other IDs
U1111-1258-8445
Status last verified
Jul 2026
First submitted
7 Apr 2021
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Lymphoma, run by Takeda at 32 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Reporting one or More Serious Adverse Events (SAEs) (time frame: Up to 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04837222.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.

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