Special Drug Use Surveillance for Brentuximab Vedotin Intravenous Infusion "Relapsed or Refractory CD30-positive Peripheral T Cell Lymphoma or Pediatric Hodgkin Lymphoma"

Peripheral T Cell Lymphoma Clinical Trial

Official title:

Special Drug Use Surveillance for Adcetris Intravenous Infusion 50 Milligrams "Relapsed or Refractory CD30-positive Peripheral T Cell Lymphoma or Hodgkin Lymphoma (Only Pediatric Patients)"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04213209
• Other study ID #: C25021
• Secondary ID: jRCT1080224999
• Status: Completed
• Start date: December 31, 2019
• Est. completion date: December 13, 2023

Study information

• Verified date: January 2024
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: December 13, 2023
• Est. primary completion date: December 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Participants with relapsed or refractory lymphoma.

2. CD30-positive participants.

3. Participants who receive study drug after obtaining approval of CD30-positive PTCL indication of study drug.

Exclusion Criteria:

1. Participants with a history of severe hypersensitivity to Brentuximab Vedotin.

2. Participants taking bleomycin hydrochloride treatment.

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Pediatric Hodgkin Lymphoma
• Peripheral T Cell Lymphoma

Intervention

Drug:
• Brentuximab Vedotin (Genetical Recombination)
Brentuximab Vedotin Intravenous Infusion

Locations

Country	Name	City	State
Japan	Takeda Selected Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants who Experienced Peripheral Neuropathy		Up to 12 Months
Primary	Percentage of Participants who Experienced Myelosuppression Resulted in Neutropenia		Up to 12 Months
Primary	Percentage of Participants who Experienced Lung Disorder		Up to 12 Months
Secondary	Percentage of Participants Who Achieve or Maintain Any Best Response for PTCL excluding adult T-cell leukemia/lymphoma (ATLL), or Pediatric HL	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.	Up to 12 Months
Secondary	Percentage of Participants Who Achieve or Maintain Any Best Response for ATLL	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.	Up to 12 Months
Secondary	Percentage of Participants with Grade 3 or Higher Adverse Event (AE)	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.	Up to 12 Months

External Links

•   To obtain more information on the study, click here/on this link