Clinical trial NCT04837222: A Study of Brentuximab Vedotin in Adults With CD30-positive Lymphoma
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)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lymphoma
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-04-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Number of Participants Reporting one or More Serious Adverse Events (SAEs)
timeFrame: Up to 4 years
Secondary outcomes:
measure: Number of Participants Reporting one or More Adverse Events (AEs)
timeFrame: Up to 4 years
measure: Number of Participants Reporting one or More Adverse Drug Reactions (ADRs)
timeFrame: Up to 4 years
measure: Number of Participants With Dose Adjustments During the Study
timeFrame: Up to 4 years
measure: Number of Participants Based on Usage of Brentuximab Vedotin
timeFrame: Up to 4 years
measure: Number of Cycles of Brentuximub Vedotin Administered in Routine Clinical Practice
timeFrame: Up to 4 years
measure: Number of Participants Based on Disease Characteristics
timeFrame: Up to 4 years
measure: Time to Next Treatment (TTNT)
timeFrame: From start of each line of therapy until next line of therapy (up to 4 years)
measure: Objective Response Rate (ORR)
timeFrame: Up to 4 years
measure: Duration of Response (DOR)
timeFrame: From date of first documented CR until PD (up to 4 years)
measure: Progression Free Survival (PFS) Rate
timeFrame: 1 year and 2 years
measure: Overall Survival (OS) Rate
timeFrame: 1 year and 2 years
measure: Change From Baseline in Quality of Life (QoL) Assessed Using Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Questionnaire Version 4
timeFrame: Up to 4 years
measure: Cost-effectiveness Ratio
timeFrame: Up to 4 years
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital
state: Anhui
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospita
state: Beijing
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: ZhuJiang Hosptital of Southern Medical University
state: Guangdong
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guangdong
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
state: Hebei
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
state: Henan
city: Zhengzhou
country: China
facility: HenanProvincial CancerHospital
state: Henan
city: Wuhan
country: China
facility: Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Nantong
country: China
facility: Affiliated Hodpital of Nantong University
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: The first hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: The Second Hospital of Dalian Medical University
state: Liaoning
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: ShandongProvincial CancerHospital
state: Shandong
city: Shanghai
country: China
facility: Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Taiyuan
country: China
facility: ShanxiProvincial CancerHospital
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Hematology Hospital of Chinese Academy of Medical Sciences
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin People's Hospital
state: Tianjin
city: Kunming
country: China
facility: Yunnan First People's Hospital
state: Yunnan
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Ningbo
country: China
facility: The Affiliated People's Hospital of Ningbo University
state: Zhejiang
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: