drugset / Trial / NCT07706959
New Genotype-guided Treatment in Newly Diagnosed PTCL
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a phase I/II study evaluate the safety and efficacy targeted agents in combination with standard CHOP in new genotypic subtypes in treatment naive peripheral T-cell lymphoma. Phase I is to confirm RP2D of targeted agent. Phase II is a multicenter, prospective, randomized, open-label, controlled design to evaluate the efficacy and safety of new genotype-guided targeted agents plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP-X2) versus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in patients with peripheral T-cell lymphoma.
Timeline
- Start
- 2026-07
- Primary completion
- 2028-01
- Completion
- 2029-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | — | — |
| Subject | Decitabine | Small molecule | — | — |
| Subject | Golidocitinib | Small molecule | — | — |
| Subject | Selinexor | Other / unclassified | 40 mg | — |
| Subject | Tucidinostat | Small molecule | 20 mg | — |
| Subject | Zeprumetostat | Small molecule | — | — |
| Background | Cyclophosphamide | Other / unclassified | 750 mg/m2 | Intravenous |
| Background | Doxorubicin | Other / unclassified | 50 mg/m2 | Intravenous |
| Background | Prednisone | Other / unclassified | 100 mg | Oral |
| Background | Vincristine | Small molecule | 1.4 mg/m2 | Intravenous |