Trials / Completed
CompletedNCT04213209
Special Drug Use Surveillance for Brentuximab Vedotin Intravenous Infusion "Relapsed or Refractory CD30-positive Peripheral T Cell Lymphoma or Pediatric Hodgkin Lymphoma"
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)"
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 95 (actual)
- Sponsor
- Takeda · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Brentuximab Vedotin (Genetical Recombination) | Brentuximab Vedotin Intravenous Infusion |
Timeline
- Start date
- 2020-02-14
- Primary completion
- 2023-12-13
- Completion
- 2023-12-13
- First posted
- 2019-12-30
- Last updated
- 2024-09-27
- Results posted
- 2024-09-27
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT04213209. Inclusion in this directory is not an endorsement.