drugset / Trial / NCT05673785

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)

NCT05673785

Phase 2 Active not recruiting 52 enrolled Takeda
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2023-02-10
Primary completion
2025-04-27
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Brentuximab Vedotin Monoclonal antibody 1.8 mg/kg Intravenous
Subject Cyclophosphamide Other / unclassified 750 mg/m2 Intravenous
Subject Doxorubicin Other / unclassified 50 mg/m2 Intravenous
Subject Prednisone Other / unclassified 100 mg Oral

Indications