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Trial Title:
A Survey of Brentuximab Vedotin in Pediatric Participants With Hodgkin Lymphoma
NCT ID:
NCT05481437
Condition:
Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Hodgkin Disease
Brentuximab Vedotin
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Brentuximab Vedotin
Description:
Brentuximab Vedotin injection, 50 mg, once every 2 weeks
Arm group label:
Brentuximab Vedotin
Other name:
ADCETRIS Intravenous Infusion
Summary:
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.
Criteria for eligibility:
Study pop:
The population of this survey are all participants who meet the inclusion/exclusion
criteria.
Sampling method:
Probability Sample
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.
Gender:
All
Minimum age:
N/A
Maximum age:
18 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Takeda selected site
Address:
City:
Tokyo
Country:
Japan
Status:
Recruiting
Start date:
August 1, 2022
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Takeda
Agency class:
Industry
Source:
Takeda
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05481437
https://clinicaltrials.takeda.com/study-detail/9bb9378e41504b5a
