Survey of Brentuximab Vedotin for treating pediatric Hodgkin Lymphoma
Specified Drug Use Surveillance for ADCETRIS Intravenous Infusion 50 mg -Untreated CD30 Positive Hodgkin Lymphoma (Pediatric)
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 |
|---|---|
| Enrollment | 8 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Takeda Industry-sponsored |
| Drugs / interventions | doxorubicin, Brentuximab |
| Locations | 1 site (Tokyo, Tokyo) |
| Trial ID | NCT05481437 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are treatment-naive children and teenagers under 18 years old with CD30 positive Hodgkin lymphoma.
Not a fit: Patients with contraindications to Brentuximab Vedotin will not benefit from this study.
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 performed: While this study is observational, similar studies on Brentuximab Vedotin have shown promising results in adult populations, indicating potential for success in pediatric cases.
Eligibility criteria
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 this trial is running
Tokyo, Tokyo
- Takeda selected site — Tokyo, Tokyo, Japan (Recruiting)
Study contacts
- Study coordinator: Takeda Contact
- Email: medinfoUS@takeda.com
- Phone: +1-877-825-3327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.