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

Lymphoma Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04837222
• Other study ID #: C25022
• Secondary ID: U1111-1258-8445
• Status: Recruiting
• Start date: June 7, 2021
• Est. completion date: January 1, 2025

Study information

• Verified date: August 2023
• Source: Takeda
• Contact: Takeda Contact
• Phone: +1-877-825-3327
• Email: medinfoUS[@]takeda.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Other aims are to collect information on how brentuximab vedotin is used to treat these participants and the outcomes of these participants.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma

Intervention

Other:
• No Intervention
This is a non-interventional study.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing
China	Peking University Third Hospita	Beijing	Beijing
China	The first hospital of Jilin University	Changchun	Jilin
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	The Second Hospital of Dalian Medical University	Dalian	Liaoning
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	ZhuJiang Hosptital of Southern Medical University	Guangzhou	Guangdong
China	The Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Anhui Provincial Cancer Hospital	Hefei	Anhui
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	ShandongProvincial CancerHospital	Jinan	Shandong
China	Yunnan First People's Hospital	Kunming	Yunnan
China	The First Affiliated Hospital of Henan University of Science and Technology	Luoyang	Henan
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Zhongda Hospital Southeast University	Nanjing	Jiangsu
China	Affiliated Hodpital of Nantong University	Nantong	Jiangsu
China	The Affiliated People's Hospital of Ningbo University	Ningbo	Zhejiang
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Peking University Shenzhen Hospital	Shenzhen	Guangdong
China	The Fourth Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	ShanxiProvincial CancerHospital	Taiyuan	Shanxi
China	Hematology Hospital of Chinese Academy of Medical Sciences	Tianjin	Tianjin
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin	Tianjin
China	Tianjin People's Hospital	Tianjin	Tianjin
China	Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei
China	Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian
China	HenanProvincial CancerHospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Reporting one or More Serious Adverse Events (SAEs)		Up to 4 years
Secondary	Number of Participants Reporting one or More Adverse Events (AEs)		Up to 4 years
Secondary	Number of Participants Reporting one or More Adverse Drug Reactions (ADRs)	ADRs refers to AE related to administered drug.	Up to 4 years
Secondary	Number of Participants With Dose Adjustments During the Study		Up to 4 years
Secondary	Number of Participants Based on Usage of Brentuximab Vedotin		Up to 4 years
Secondary	Number of Cycles of Brentuximub Vedotin Administered in Routine Clinical Practice		Up to 4 years
Secondary	Number of Participants Based on Disease Characteristics	Number of participants will be reported based on the type of lymphoma, stage, lines of therapy.	Up to 4 years
Secondary	Time to Next Treatment (TTNT)	TTNT is defined as time between start of each line of a therapy to the next line of therapy.	From start of each line of therapy until next line of therapy (up to 4 years)
Secondary	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.	Up to 4 years
Secondary	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.	From date of first documented CR until PD (up to 4 years)
Secondary	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.	1 year and 2 years
Secondary	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.	1 year and 2 years
Secondary	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.	Up to 4 years
Secondary	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.	Up to 4 years

External Links

•   To obtain more information on the study, click here/on this link