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Completed

NCT Number: NCT04837222

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

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.

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Key information

Conditions

Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Anhui Provincial Cancer Hospital, Hefei, Anhui, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

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

Treatment and study plan

No intervention

Other

This is a non-interventional study.

Primary outcomes

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

    Time frame: Up to 4 years

Secondary outcomes

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

    Time frame: Up to 4 years

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

    Time frame: Up to 4 years

    ADRs refers to AE related to administered drug.

  3. Number of Participants With Dose Adjustments During the Study

    Time frame: Up to 4 years

  4. Number of Participants Based on Usage of Brentuximab Vedotin

    Time frame: Up to 4 years

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

    Time frame: Up to 4 years

  6. Number of Participants Based on Disease Characteristics

    Time frame: Up to 4 years

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

  7. Time to Next Treatment (TTNT)

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

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

  8. Objective Response Rate (ORR)

    Time frame: Up to 4 years

    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.

  9. Duration of Response (DOR)

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

    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.

  10. Progression Free Survival (PFS) Rate

    Time frame: 1 year and 2 years

    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.

  11. Overall Survival (OS) Rate

    Time frame: 1 year and 2 years

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

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

    Time frame: Up to 4 years

    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.

  13. Cost-effectiveness Ratio

    Time frame: Up to 4 years

    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.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study 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)

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2021
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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