Survey of Brentuximab Vedotin for treating pediatric Hodgkin Lymphoma
Official title: Specified Drug Use Surveillance for ADCETRIS Intravenous Infusion 50 mg -Untreated CD30 Positive Hodgkin Lymphoma (Pediatric)
Run by Takeda · NCT05481437 · Data updated 2026-11-12
This study looks at how well Brentuximab Vedotin works with standard treatment for kids with Hodgkin lymphoma and checks for any side effects they might have.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 18 Years |
| Sex | All |
| Enrollment | 8 (estimated) |
| Sponsor | Takeda Industry-sponsored |
| Drugs / interventions | doxorubicin, Brentuximab |
| Locations | 1 site (Tokyo, Tokyo) |
| Status | Recruiting |
| Started | August 1, 2022 |
| Main results expected | July 31, 2027 |
| Study ends | July 31, 2027 |
| Registry record updated | April 13, 2026 |
| Trial ID | NCT05481437 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are treatment-naive children and teenagers under 18 years old with CD30 positive Hodgkin lymphoma.
✕Probably not a fit
Patients with contraindications to Brentuximab Vedotin will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study in Japan focuses on pediatric participants with Hodgkin lymphoma receiving Brentuximab Vedotin in combination with AVD treatment. The study aims to monitor and document side effects associated with Brentuximab Vedotin, particularly myelosuppression, peripheral neuropathy, and lung disorders. Participants will be treated according to their clinic's standard practices, and the study will last for 26 weeks, during which side effects will be closely observed and recorded. The study sponsor will provide guidelines for data collection but will not influence treatment decisions.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the safety profile of Brentuximab Vedotin in children with Hodgkin lymphoma.
How similar studies have gone: While this study is observational, similar studies on Brentuximab Vedotin have shown promising results in adult populations, indicating potential for success in pediatric cases.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Treatment-naive participants 2. CD30 positive participants 3. Participants treated with the study drug in combination with doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine (AVD). 4. Participants aged \< 18 years at the start of this drug. Exclusion Criteria: Participants with contraindications to the study drug.
Where it's running
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Takeda selected site
Tokyo, Tokyo, Japan Recruiting
Study contacts
- Study coordinator: Takeda Contact
- Email: medinfoUS@takeda.com
- Phone: +1-877-825-3327
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.