CompletedNot Applicable

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

Japan95 participantsStarted 2020-02-14

Plain-language 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.

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

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

What they're measuring

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

Timeframe: Up to 12 Months

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

Timeframe: Up to 12 Months

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

Timeframe: Up to 12 Months

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

Timeframe: Up to 12 Months

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

Timeframe: Up to 12 Months

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

Timeframe: Up to 12 Months

Trial details

NCT IDNCT04213209

SponsorTakeda

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-12-13

Results submitted2024-06-10

View on ClinicalTrials.gov More Peripheral T Cell Lymphoma trials

Plain-language summary

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

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

What they're measuring

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

Timeframe: Up to 12 Months

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

Timeframe: Up to 12 Months

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

Timeframe: Up to 12 Months

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

Timeframe: Up to 12 Months

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

Timeframe: Up to 12 Months

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

Timeframe: Up to 12 Months