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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04837222
Recruitment Status : Recruiting
First Posted : April 8, 2021
Last Update Posted : March 9, 2022
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Description
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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.


Condition or disease Intervention/treatment
Lymphoma Other: No Intervention

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Actual Study Start Date : June 7, 2021
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : January 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Other: No Intervention
This is a non-interventional study.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants Reporting one or More Serious Adverse Events (SAEs) [ Time Frame: Up to 4 years ]

Secondary Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with CD30-positive lymphoma, who have been prescribed brentuximab vedotin in clinical practice will be observed prospectively.
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04837222


Contacts
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Contact: Takeda Contact +1-877-825-3327 medinfoUS@takeda.com

Locations
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Sponsors and Collaborators
Takeda
Investigators
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Study Director: Study Director Takeda
More Information
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Additional Information:

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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT04837222    
Other Study ID Numbers: C25022
U1111-1258-8445 ( Registry Identifier: WHO )
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: March 9, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.
URL: https://vivli.org/ourmember/takeda/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeda:
Drug Therapy
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases