A Survey of Brentuximab Vedotin in Pediatric Participants With Hodgkin Lymphoma

Sponsor
Takeda (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05481437
Collaborator
(none)
8
1
60
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Brentuximab Vedotin

Study Design

Study Type:
Observational
Anticipated Enrollment :
8 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Specified Drug Use Surveillance for ADCETRIS Intravenous Infusion 50 mg -Untreated CD30 Positive Hodgkin Lymphoma (Pediatric)
Actual Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Jul 31, 2027
Anticipated Study Completion Date :
Jul 31, 2027

Arms and Interventions

Arm Intervention/Treatment
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
Brentuximab Vedotin injection, 50 mg, once every 2 weeks
Other Names:
  • ADCETRIS Intravenous Infusion
  • Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants who Experienced Myelosuppression [Up to 26 Weeks]

    2. Percentage of Participants who Experienced Peripheral Neuropathy [Up to 26 Weeks]

    3. Percentage of Participants who Experienced Lung Disorder [Up to 26 Weeks]

    Secondary Outcome Measures

    1. 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.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Takeda selected site Tokyo Japan

    Sponsors and Collaborators

    • Takeda

    Investigators

    • Study Director: Study Director, Takeda

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Takeda
    ClinicalTrials.gov Identifier:
    NCT05481437
    Other Study ID Numbers:
    • Brentuximab-5019
    • jRCT2031220244
    First Posted:
    Aug 1, 2022
    Last Update Posted:
    Aug 22, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 22, 2022