Special Drug Use Surveillance for Brentuximab Vedotin Intravenous Infusion "Relapsed or Refractory CD30-positive Peripheral T Cell Lymphoma or Pediatric Hodgkin Lymphoma"
Study Details
Study Description
Brief Summary
The purpose of this survey is to examine the safety of adult patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL) (excluding anaplastic large cell lymphoma (ALCL)) and pediatric patients with relapsed or refractory CD30-positive PTCL or Hodgkin lymphoma (HL) in the actual use of on concomitant Brentuximab Vedotin in routine clinical practice.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The drug being tested in this survey is called Brentuximab Vedotin intravenous infusion 50 mg. This intravenous infusion is being tested to treat adult patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL) (excluding anaplastic large cell lymphoma (ALCL)) and pediatric patients with relapsed or refractory CD30-positive PTCL or Hodgkin lymphoma (HL).
This survey is an observational (non-interventional) study and will look at the safety of adult patients with relapsed or refractory CD30-positive PTCL (excluding ALCL) and pediatric patients with relapsed or refractory CD30-positive PTCL or HL in the routine clinical setting. The number of observed patients will be approximately 86 as total (80; Adult participants and 6; Pediatric participants).
This multi-center observational survey will be conducted in Japan.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Brentuximab Vedotin 1.8 mg/kg (body weight) The usual dosage for intravenous administration is 1.8 milligrams per kilograms (mg/kg) (body weight) as Brentuximab Vedotin (genetic recombination) once every three weeks (up to 12 months). The dose may be reduced appropriately according to the participant's condition. Participants receive interventions as part of routine medical care. |
Drug: Brentuximab Vedotin (Genetical Recombination)
Brentuximab Vedotin Intravenous Infusion
Other Names:
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Outcome Measures
Primary Outcome Measures
- Percentage of Participants who Experienced Peripheral Neuropathy [Up to 12 Months]
- Percentage of Participants who Experienced Myelosuppression Resulted in Neutropenia [Up to 12 Months]
- Percentage of Participants who Experienced Lung Disorder [Up to 12 Months]
Secondary Outcome Measures
- Percentage of Participants Who Achieve or Maintain Any Best Response for PTCL excluding adult T-cell leukemia/lymphoma (ATLL), or Pediatric HL [Up to 12 Months]
Best response is defined as the cumulative numbers of participants who achieve each level of best response including complete response (CR), complete response uncertain (CRu) (when no positron emission tomography [PET] data are available), partial response (PR), Stable Disease (SD), and Progressive Disease (PD) after treatment. Best response will be assessed by Cheson 2010 Revised Response Criteria for Malignant Lymphoma. PET and Computed Tomography (CT) will be used in cancer diagnosis and treatment.
- Percentage of Participants Who Achieve or Maintain Any Best Response for ATLL [Up to 12 Months]
Best response is defined as the cumulative numbers of participants who achieve each level of best response including complete response (CR), partial response (PR), Stable Disease (SD), Progressive Disease (PD) and Not Evaluable (NE) after treatment. Best response will be assessed by Japan Clinical Oncology Group (JCOG) Response Criteria for ATLL. PET and CT will be used in cancer diagnosis and treatment.
- Percentage of Participants with Grade 3 or Higher Adverse Event (AE) [Up to 12 Months]
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 life-threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to AE.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Participants with relapsed or refractory lymphoma.
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CD30-positive participants.
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Participants who receive study drug after obtaining approval of CD30-positive PTCL indication of study drug.
Exclusion Criteria:
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Participants with a history of severe hypersensitivity to Brentuximab Vedotin.
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Participants taking bleomycin hydrochloride treatment.
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
Publications
None provided.- C25021
- JapicCTI-195090