Clinical trial NCT04213209: Special Drug Use Surveillance for Brentuximab Vedotin Intravenous Infusion "Relapsed or Refractory CD30-positive Peripheral T Cell Lymphoma or Pediatric Hodgkin Lymphoma"
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)"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral T Cell Lymphoma
Pediatric Hodgkin Lymphoma
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2019-12-30
Enrollment: 95
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy
timeFrame: Up to 12 Months
measure: Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Peripheral Neuropathy
timeFrame: Up to 12 Months
measure: Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression
timeFrame: Up to 12 Months
measure: Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression
timeFrame: Up to 12 Months
measure: Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Lung Disorder
timeFrame: Up to 12 Months
measure: Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Lung Disorder
timeFrame: Up to 12 Months
Secondary outcomes:
measure: 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
timeFrame: Up to 12 Months
measure: Percentage of Participants Who Achieve or Maintain Any Best Response for Adult Participants With ATLL
timeFrame: Up to 12 Months
measure: Percentage of Participants Who Achieve or Maintain Any Best Response for Pediatric Participants With PTCL and HL
timeFrame: Up to 12 Months
measure: Percentage of Participants Who Had One or More Adverse Event
timeFrame: Up to 12 Months
measure: Percentage of Participants Who Had One or More Adverse Drug Reaction
timeFrame: Up to 12 Months
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Takeda Selected Site
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: