Trials / Active Not Recruiting
Active Not RecruitingNCT05673785
A Study of Brentuximab Vedotin in Combination With Cyclophosphamide, Doxorubicin (Hydroxydaunorubicin), Prednisone (CHP) in Chinese Participants With CD30-Positive (CD30+) Peripheral T-Cell Lymphomas (PTCL)
A Phase 2, Single-Arm, Open-Label, Multicenter Study of Brentuximab Vedotin in Combination With Cyclophosphamide, Doxorubicin (Hydroxydaunorubicin), Prednisone (CHP) in the Frontline Treatment of Chinese Patients With CD30-Positive (CD30+) Peripheral T-Cell Lymphomas (PTCL)
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- Takeda · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will use a combination of Brentuximab vedotin with CHP to treat adult Chinese participants with CD30+ PTCL. The main aims of the study are to evaluate: * Side effect from the A+CHP * Check how much A+CHP stays in their blood over time. This will help Takeda to work out the best dose to give people in the future. * If A+CHP improves outcome of newly diagnosed CD30+ PTCL Brentuximab vedotin will be given through vein on Day 1 of each 21-day cycle. Cyclophosphamide and doxorubicin will be given through vein. Prednisone will be given orally daily on Days 1 through 5.
Detailed description
The drug being tested in this study is called brentuximab vedotin. Brentuximab vedotin is being tested to treat CD30+ PTCL in Chinese participants. This study will look at the efficacy, safety, and pharmacokinetics (PK) of A+CHP as frontline treatment for newly diagnosed CD30+ PTCL. The study will enroll approximately 52 participants. Participants will be enrolled in a single group to receive: • Brentuximab vedotin 1.8 milligrams per kilogram (mg/kg) + Cyclophosphamide 750 milligrams per square meter (mg/m\^2), Doxorubicin 50 mg/m\^2 and Prednisone 100 mg This multi-center trial will be conducted in China. The overall time to participate in this study is approximately 36 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Brentuximab Vedotin | Brentuximab vedotin IV infusion |
| DRUG | Cyclophosphamide | Cyclophosphamide IV infusion |
| DRUG | Doxorubicin | Doxorubicin IV infusion |
| DRUG | Prednisone | Prednisone tablets |
Timeline
- Start date
- 2023-02-10
- Primary completion
- 2025-04-27
- Completion
- 2027-12-31
- First posted
- 2023-01-06
- Last updated
- 2025-07-14
Locations
16 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05673785. Inclusion in this directory is not an endorsement.