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.
Study Type
OBSERVATIONAL
Enrollment
1,000
This is a non-interventional study.
Number of Participants Reporting one or More Serious Adverse Events (SAEs)
Time frame: Up to 4 years
Number of Participants Reporting one or More Adverse Events (AEs)
Time frame: Up to 4 years
Number of Participants Reporting one or More Adverse Drug Reactions (ADRs)
ADRs refers to AE related to administered drug.
Time frame: Up to 4 years
Number of Participants With Dose Adjustments During the Study
Time frame: Up to 4 years
Number of Participants Based on Usage of Brentuximab Vedotin
Time frame: Up to 4 years
Number of Cycles of Brentuximub Vedotin Administered in Routine Clinical Practice
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Anhui Provincial Cancer Hospital
Hefei, Anhui, China
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospita
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
ZhuJiang Hosptital of Southern Medical University
Guangzhou, Guangdong, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
...and 22 more locations
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 4 years