Clinical trial · Observational
A Survey of Brentuximab Vedotin in Pediatric Participants With Hodgkin Lymphoma
Specified Drug Use Surveillance for ADCETRIS Intravenous Infusion 50 mg -Untreated CD30 Positive Hodgkin Lymphoma (Pediatric)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a survey in Japan of Brentuximab Vedotin used to treat children or teenagers with Hodgkin lymphoma (HL). The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. The main aim of the study is to check for side effects related from Brentuximab Vedotin especially myelosupression, peripheral neuropathy, and lung disorder. During the study, pediatric participants with HL will take Brentuximab Vedotin injection and AVD treatment (doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine) according to their clinic's standard practice. The study doctors will check for side effects from Brentuximab Vedotin for 26 weeks.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brentuximab Vedotin | Drug | Brentuximab Vedotin | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Brentuximab Vedotin
- description
- Participants will receive Brentuximab Vedotin injection 50 mg once every 2 weeks and AVD treatment (doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine).
- interventionNames
- Drug: Brentuximab Vedotin
Primary outcomes (3)
- measure
- Percentage of Participants who Experienced Myelosuppression
- timeFrame
- Up to 26 Weeks
- measure
- Percentage of Participants who Experienced Peripheral Neuropathy
- timeFrame
- Up to 26 Weeks
- measure
- Percentage of Participants who Experienced Lung Disorder
- timeFrame
- Up to 26 Weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available