drugset / Trial / NCT05678933
AC-CHOP Versus CHOP in Patients With Previously Untreated PTCL-TFH
Phase 3
Enrolling by invitation
200 enrolled
Tianjin Medical University Cancer Institute and Hospital
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is an open label, multicenter study. Subjects are randomized at a 1:1 ratio to receive either (arm A) azacitidine administered IH at day 1-5 and chidamide admistered twice a week for two weeks in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) or (arm B) CHOP administered every 3 weeks for 6 cycles in patients with previously untreated peripheral T-cell lymphoma.
Timeline
- Start
- 2023-01-01
- Primary completion
- 2027-12-01
- Completion
- 2029-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 75 mg/m2 | Subcutaneous |
| Subject | Tucidinostat | Small molecule | 20 mg | Oral |
| Background | Cyclophosphamide | Other / unclassified | 750 mg/m2 | Intravenous |
| Background | Epirubicin | Small molecule | 70 mg/m2 | Intravenous |
| Background | Prednisone | Other / unclassified | 100 mg | Oral |
| Background | Vincristine | Small molecule | 1.4 mg/m2 | Intravenous |