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)
Фаза 2
Идёт, набор закрыт
NCT05673785
| Заболевание | Lymphoma |
|---|
| Фаза | Фаза 2 |
|---|
| Спонсор | Takeda |
|---|
| Статус | Идёт, набор закрыт |
|---|
| Участники | 52 участн. |
|---|
| Вмешательство | Brentuximab Vedotin, Cyclophosphamide, Doxorubicin, Prednisone |
|---|
| Дата начала | 10.02.2023 |
|---|
| Дата завершения | 27.04.2025 |
|---|
| Публикация результатов | 12.06.2026 |
|---|
Кратко
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.
Overall Response Rate (ORR) by Independent Review Facility (IRF) Assessment Per Revised Response Criteria for Malignant Lymphoma
Up to approximately 7 months · percentage of participants
| Brentuximab Vedotin + CHP | 96.2 percentage of participants |
|---|
Percentage of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE)
Up to approximately 7 months · percentage of participants
| Brentuximab Vedotin + CHP | 100 percentage of participants |
|---|
Number of Participants With Abnormal Changes From Baseline in Laboratory Measurements
Up to approximately 7 months · Participants
| Brentuximab Vedotin + CHP | 1 Participants |
|---|
| Brentuximab Vedotin + CHP | 1 Participants |
|---|
| Brentuximab Vedotin + CHP | 1 Participants |
|---|
| Brentuximab Vedotin + CHP | 2 Participants |
|---|
| Brentuximab Vedotin + CHP | 2 Participants |
|---|
| Brentuximab Vedotin + CHP | 2 Participants |
|---|
Открыть в BENITIONS
Открыть на ClinicalTrials.gov
Все исследования
Страница обобщает открытые данные ClinicalTrials.gov. Это не медицинская и не инвестиционная рекомендация. Обратитесь к врачу.