drugset / Trial / NCT06421948
Linperlisib Combined With Chidamide in Patients With PTCL
RandomizedParallel-groupOpen-labelTreatment
Summary
The phase Ib part of this study aims to determine the recommended phase II dose （RP2D）of linperlisib in combination with chidamide for the treatment of peripheral T-cell lymphoma (PTCL). The phase IIa part is designed to evaluate the preliminary efficacy and safety of the linperlisib plus chidamide regimen in newly diagnosed PTCL patients. The phase IIb part compares the efficacy and safety of linperlisib combined with chidamide versus the standard CHOP (CHOP-like) regimen in newly diagnosed PTCL patients.
Timeline
- Start
- 2024-05-25
- Primary completion
- 2027-05-31
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclophosphamide | Other / unclassified | — | — |
| Comparator | Doxorubicin | Other / unclassified | — | — |
| Comparator | Epirubicin | Small molecule | — | — |
| Subject | Linperlisib | Small molecule | 40 mg | Oral |
| Subject | Linperlisib | Small molecule | 60 mg | Oral |
| Subject | Linperlisib | Small molecule | 80 mg | Oral |
| Comparator | Prednisone | Other / unclassified | — | — |
| Subject | Tucidinostat | Small molecule | 20 mg | — |
| Comparator | Vincristine | Small molecule | — | — |