An observational study in Lymphoma, sponsored by Takeda. Completed at 32 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Takeda · Observational
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:
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 1,000 is above the median of 136 across 625 observational studies indexed under Lymphoma.
Browse Lymphoma studies →Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants with CD30-positive lymphoma, who have been prescribed brentuximab vedotin in clinical practice will be observed prospectively.
Exclusion Criteria:
1. Who currently participates in or with plan to participate in any interventional clinical trial.
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.
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.
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
Plan to share: Yes — 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 information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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