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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1258-8445 | Registry Identifier | WHO |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | This is a non-interventional study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting one or More Serious Adverse Events (SAEs) | Up to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting one or More Adverse Events (AEs) | Up to 4 years | |
| Number of Participants Reporting one or More Adverse Drug Reactions (ADRs) | ADRs refers to AE related to administered drug. |
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Inclusion Criteria:
Exclusion Criteria:
1. Who currently participates in or with plan to participate in any interventional clinical trial.
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Participants with CD30-positive lymphoma, who have been prescribed brentuximab vedotin in clinical practice will be observed prospectively.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Cancer Hospital | Hefei | Anhui | 230001 | China | ||
| Peking Union Medical College Hospital, Chinese Academy of Medical Sciences |
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| Label | URL |
|---|---|
| Click here for more information about this trial in easy-to-understand language. | View source |
| Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language. | View source |
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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.
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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.
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| Up to 4 years |
| Number of Participants With Dose Adjustments During the Study | Up to 4 years |
| Number of Participants Based on Usage of Brentuximab Vedotin | Up to 4 years |
| Number of Cycles of Brentuximub Vedotin Administered in Routine Clinical Practice | Up to 4 years |
| 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 |
| 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) |
| 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 |
| 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) |
| 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 |
| 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 |
| 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 |
| 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 |
| Beijing |
| Beijing Municipality |
| 100010 |
| China |
| Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | China |
| Peking University Third Hospita | Beijing | Beijing Municipality | 100191 | China |
| The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | 361003 | China |
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510280 | China |
| ZhuJiang Hosptital of Southern Medical University | Guangzhou | Guangdong | 510280 | China |
| Peking University Shenzhen Hospital | Shenzhen | Guangdong | 518035 | China |
| The Fourth Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050011 | China |
| The First Affiliated Hospital of Henan University of Science and Technology | Luoyang | Henan | 471003 | China |
| HenanProvincial CancerHospital | Zhengzhou | Henan | 450003 | China |
| Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology | Wuhan | Hubei | 430022 | China |
| Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology | Wuhan | Hubei | 430023 | China |
| Zhongda Hospital Southeast University | Nanjing | Jiangsu | 210009 | China |
| Jiangsu Province Hospital | Nanjing | Jiangsu | 210029 | China |
| Affiliated Hodpital of Nantong University | Nantong | Jiangsu | 226001 | China |
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215006 | China |
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330006 | China |
| The first hospital of Jilin University | Changchun | Jilin | 130021 | China |
| The Second Hospital of Dalian Medical University | Dalian | Liaoning | 116027 | China |
| Qilu Hospital of Shandong University | Jinan | Shandong | 250012 | China |
| ShandongProvincial CancerHospital | Jinan | Shandong | 250117 | China |
| Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China |
| ShanxiProvincial CancerHospital | Taiyuan | Shanxi | 030013 | China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610041 | China |
| Hematology Hospital of Chinese Academy of Medical Sciences | Tianjin | Tianjin Municipality | 300020 | China |
| Tianjin Medical University Cancer Institute & Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| Tianjin People's Hospital | Tianjin | Tianjin Municipality | 300121 | China |
| Yunnan First People's Hospital | Kunming | Yunnan | 650032 | China |
| The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310052 | China |
| The Affiliated People's Hospital of Ningbo University | Ningbo | Zhejiang | 315040 | China |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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