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

NCT04213209 | Completed Results

• 2 other identifiers: C25021jRCT1080224999
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral T Cell Lymphoma; Pediatric Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (6)

• Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy

  An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Percentage of participants who had one or more serious or non-serious adverse event of peripheral motor neuropathy or peripheral sensory neuropathy which were classified as peripheral neuropathy was reported.

  Up to 12 Months

• Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Peripheral Neuropathy

  An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug. Percentage of participants who had one or more serious or non-serious adverse drug reaction of peripheral motor neuropathy or peripheral sensory neuropathy which were classified as peripheral neuropathy was reported.

  Up to 12 Months

• Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression

  An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Percentage of participants who had one or more serious or non-serious adverse event of febrile neutropenia, neutropenia, or neutrophil count decreased which were classified as myelosuppression was reported.

  Up to 12 Months

• Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression

  An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug. Percentage of participants who had one or more serious or non-serious adverse drug reaction of febrile neutropenia, neutropenia, or neutrophil count decreased which were classified as myelosuppression was reported.

  Up to 12 Months

• Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Lung Disorder

  An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Percentage of participants who had one or more serious or non-serious adverse event of only interstitial lung disease which were classified as lung disorder was reported.

  Up to 12 Months

• Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Lung Disorder

  An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug. Percentage of participants who had one or more serious or non-serious adverse drug reaction of only interstitial lung disease which were classified as lung disorder was reported.

  Up to 12 Months

Secondary Outcomes (5)

• Percentage of Participants Who Achieve or Maintain Any Best Response for Adult Participants With PTCL-NOS, AITL, the Other PTCL, and Pediatric Participants With PTCL

  Up to 12 Months

• Percentage of Participants Who Achieve or Maintain Any Best Response for Adult Participants With ATLL

  Up to 12 Months

• Percentage of Participants Who Achieve or Maintain Any Best Response for Pediatric Participants With PTCL and HL

  Up to 12 Months

• Percentage of Participants Who Had One or More Adverse Event

  Up to 12 Months

• Percentage of Participants Who Had One or More Adverse Drug Reaction

  Up to 12 Months

Study Arms (1)

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)

Interventions

Brentuximab Vedotin (Genetical Recombination) DRUG

Brentuximab Vedotin Intravenous Infusion

Also known as: ADCETRIS Intravenous Infusion 50 mg

Brentuximab Vedotin 1.8 mg/kg (body weight)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Participants with relapsed or refractory lymphoma.
• CD30-positive participants.
• Participants who receive study drug after obtaining approval of CD30-positive PTCL indication of study drug.

You may not qualify if:

• Participants with a history of severe hypersensitivity to Brentuximab Vedotin.
• Participants taking bleomycin hydrochloride treatment.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Takeda Selected Site

Tokyo, Japan

Location

Related Links

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

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

Brentuximab Vedotin

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2019
• First Posted: December 30, 2019
• Study Start: February 14, 2020
• Primary Completion: December 13, 2023
• Study Completion: December 13, 2023
• Last Updated: September 27, 2024
• Results First Posted: September 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.

Locations

JP (1)