N/A N=95

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

Peripheral T Cell Lymphoma · Pediatric Hodgkin Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT04213209 ↗

Enrolled (actual)

Serious AEs

29.8%

Results posted

Sep 2024

Primary outcome: Primary: Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy — 0; 0; 0; 0 Participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Brentuximab Vedotin (Genetical Recombination) (Drug)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Takeda
Primary completion: Dec 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy	0; 0; 0; 0; 0; 0	—
PRIMARY Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Peripheral Neuropathy	0; 0; 0; 0; 0; 0	—
PRIMARY Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression	1; 1; 0; 0; 1; 0	—
PRIMARY Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression	1; 0; 0; 0; 0; 0	—
PRIMARY Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Lung Disorder	1; 1; 0; 0; 0; 0	—
PRIMARY Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Lung Disorder	1; 1; 0; 0; 0; 0	—
SECONDARY 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	7; 12; 0; 1; 4; 5	—
SECONDARY Percentage of Participants Who Achieve or Maintain Any Best Response for Adult Participants With ATLL	3	—
SECONDARY Percentage of Participants Who Achieve or Maintain Any Best Response for Pediatric Participants With PTCL and HL	3; 2	—
SECONDARY Percentage of Participants Who Had One or More Adverse Event	21; 22; 8; 5; 3; 3	—
SECONDARY Percentage of Participants Who Had One or More Adverse Drug Reaction	20; 18; 6; 3; 2; 1	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04213209). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.