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

Overview

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.

Full Title of Study: “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)”"

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2022

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.

Interventions

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

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Participants who Experienced Peripheral Neuropathy
    • Time Frame: Up to 12 Months
  • Percentage of Participants who Experienced Myelosuppression Resulted in Neutropenia
    • Time Frame: Up to 12 Months
  • Percentage of Participants who Experienced Lung Disorder
    • Time Frame: Up to 12 Months

Secondary Measures

  • Percentage of Participants Who Achieve or Maintain Any Best Response for PTCL excluding adult T-cell leukemia/lymphoma (ATLL), or Pediatric HL
    • Time Frame: 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
    • Time Frame: 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)
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Takeda
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Study Director, Study Director, Takeda
  • Overall Contact(s)
    • Takeda Study Registration Call Center, +1-877-825-3327, medicalinformation@tpna.com

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