A Survey of Brentuximab Vedotin in Pediatric Participants With Hodgkin Lymphoma

NCT ID: NCT05481437

Last Updated: 2025-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-01

Study Completion Date

2027-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hodgkin Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Brentuximab Vedotin

Participants will receive Brentuximab Vedotin injection 50 mg once every 2 weeks and AVD treatment (doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine).

Brentuximab Vedotin

Intervention Type DRUG

Brentuximab Vedotin injection, 50 mg, once every 2 weeks

Interventions

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Brentuximab Vedotin

Brentuximab Vedotin injection, 50 mg, once every 2 weeks

Intervention Type DRUG

Other Intervention Names

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ADCETRIS Intravenous Infusion

Eligibility Criteria

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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.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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Takeda selected site

Tokyo, , Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Takeda Contact

Role: CONTACT

+1-877-825-3327

Related Links

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https://clinicaltrials.takeda.com/study-detail/9bb9378e41504b5a

To obtain more information on the study, click here/on this link

Other Identifiers

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jRCT2031220244

Identifier Type: REGISTRY

Identifier Source: secondary_id

Brentuximab-5019

Identifier Type: -

Identifier Source: org_study_id

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