A Survey of Brentuximab Vedotin in Pediatric Participants With Hodgkin Lymphoma
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 |
|---|---|---|
|
Study Design
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:
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Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Treatment-naive participants
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CD30 positive participants
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Participants treated with the study drug in combination with doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine (AVD).
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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.- Brentuximab-5019
- jRCT2031220244