A Survey of Brentuximab Vedotin in Pediatric Participants With Hodgkin Lymphoma

NCT05481437 | Recruiting

• 2 other identifiers: Brentuximab-5019jRCT2031220244
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants who Experienced Myelosuppression

  Up to 26 Weeks

• Percentage of Participants who Experienced Peripheral Neuropathy

  Up to 26 Weeks

• Percentage of Participants who Experienced Lung Disorder

  Up to 26 Weeks

Secondary Outcomes (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)

  Up to 26 Weeks

• Percentage of Participants Who Achieve or Maintain Any Best Response

  Up to 26 Weeks

Study Arms (1)

Brentuximab Vedotin

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

Drug: Brentuximab Vedotin

Interventions

Brentuximab Vedotin DRUG

Brentuximab Vedotin injection, 50 mg, once every 2 weeks

Also known as: ADCETRIS Intravenous Infusion

Brentuximab Vedotin

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The population of this survey are all participants who meet the inclusion/exclusion criteria.

You may qualify if:

• 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.

You may not qualify if:

• Participants with contraindications to the study drug.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Takeda selected site

Tokyo, Tokyo, Japan

RECRUITING

Related Links

• Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.
• Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Brentuximab Vedotin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

+1-877-825-3327; medinfoUS@takeda.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 1, 2022
• Study Start: August 1, 2022
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)