A Survey of Brentuximab Vedotin in Pediatric Participants With Hodgkin Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Brentuximab Vedotin.
- Who it may be relevant to
- Registry conditions: Hodgkin Lymphoma. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Specified Drug Use Surveillance for ADCETRIS Intravenous Infusion 50 mg -Untreated CD30 Positive Hodgkin Lymphoma (Pediatric)
Overview
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.
Interventions
- Drug Brentuximab Vedotin
Brentuximab Vedotin injection, 50 mg, once every 2 weeks
Primary outcome measures
- Percentage of Participants who Experienced Myelosuppression [Time frame: Up to 26 Weeks]
- Percentage of Participants who Experienced Peripheral Neuropathy [Time frame: Up to 26 Weeks]
- Percentage of Participants who Experienced Lung Disorder [Time frame: Up to 26 Weeks]
Secondary outcome measures (2)
- Percentage of Participants with Adverse Event (AE) Leading to Brentuximab Vedotin Discontinuation, Serious Adverse Event (SAE), and Grade 3 or Higher Adverse Event (AE) [Time frame: Up to 26 Weeks]
- Percentage of Participants Who Achieve or Maintain Any Best Response [Time frame: Up to 26 Weeks]
Eligibility criteria
Inclusion criteria
- Treatment-naive participants
- CD30 positive participants
- Participants treated with the study drug in combination with doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine (AVD).
- Participants aged < 18 years at the start of this drug.
Exclusion criteria
Participants with contraindications to the study drug.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Japan · 1 center
- Takeda selected site — Tokyo
Identifiers
NCT: NCT05481437 · Brentuximab-5019 · jRCT2031220244