A Survey of Brentuximab Vedotin in Pediatric Participants With Hodgkin Lymphoma

Recruiting

• Conditions: Hodgkin Lymphoma
• Interventions: Drug: Brentuximab Vedotin

• Registration Number: NCT05481437
• Lead Sponsor: Takeda

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-28
• Study First Submitted QC: 2022-07-28
• Study Start: 2022-08-01
• Study First Posted: 2022-08-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-18
• Primary Completion: 2027-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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	An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product. An adverse event does not necessarily have a causal relationship with the intervention. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Severity grades will be evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE). Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately lifethreatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to AE.
Percentage of Participants Who Achieve or Maintain Any Best Response	Up to 26 Weeks	Best response is defined as the cumulative numbers of participants who achieve each level of best response including complete response (CR), complete response/unconfirmed (CRu), partial response (PR), Stable Disease (SD), Progressive Disease (PD) and Relapsed Disease (RD) after treatment. Best response will be assessed by International Working Group (IWG) criteria or Antitumor effect assessment criteria for pediatric HL of Japan Childhood Leukemia and Lymphoma Study Group (JPLSG) version.

Trial Locations

Locations (1)

Takeda selected site; 🇯🇵 Tokyo, Japan