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

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)"

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.

Study Overview

• Status: Completed
• Conditions: Peripheral T Cell Lymphoma; Pediatric Hodgkin Lymphoma
• Intervention / Treatment: Drug: Brentuximab Vedotin (Genetical Recombination)

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 Type: Observational
• Enrollment (Actual): 95

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Takeda selected site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with relapsed or refractory CD30-positive PTCL (excluding ALCL) and pediatric patients with relapsed or refractory CD30-positive PTCL or HL as part of routine medical care.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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: ADCETRIS Intravenous Infusion 50 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Study Director, Takeda

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2019
• Primary Completion (Actual): December 13, 2023
• Study Completion (Actual): December 13, 2023

Study Registration Dates

• First Submitted: December 25, 2019
• First Submitted That Met QC Criteria: December 25, 2019
• First Posted (Actual): December 30, 2019

Study Record Updates

• Last Update Posted (Estimated): January 15, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Hodgkin Disease; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Physiological Effects of Drugs; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Immunoconjugates; Immunotoxins; Brentuximab Vedotin
• Other Study ID Numbers: C25021; jRCT1080224999 (Registry Identifier: jRCT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No