drugset / Trial / NCT05675813
Genotype-guided Treatment in Newly Diagnosed PTCL
Phase 1/2
Recruiting
264 enrolled
Ruijin Hospital
Anhui Provincial Cancer Hospital · collabBeijing Tongren Hospital · collabNanfang Hospital, Southern Medical University · collabPeking University People's Hospital · collabPeking University Third Hospital · collabSun Yat-sen University · collabThe First Affiliated Hospital of Anhui Medical University · collabThe First Affiliated Hospital of Nanchang University · collabThe First Affiliated Hospital of Soochow University · collabThe First Affiliated Hospital of Xiamen University · collabThe First Affiliated Hospital of Zhengzhou University · collabThe First Hospital of Jilin University · collabThe Second Affiliated Hospital of Harbin Medical University · collabWest China Hospital · collabWuhan TongJi Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study includes Phase I and Phase II stages. Phase I is an open-label trial to confirm RP2D of oral targeted agents in three genetic subtypes. Phase II is a multicenter, prospective, randomized, open-label, controlled trial to evaluate the efficacy and safety of 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
- 2023-02-13
- Primary completion
- 2026-07-15
- Completion
- 2028-07-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | — | — |
| Subject | Duvelisib | Small molecule | 25 mg | Oral |
| Subject | Duvelisib | Small molecule | 50 mg | Oral |
| Subject | Selinexor | Other / unclassified | 40 mg | Oral |
| Subject | Selinexor | Other / unclassified | 60 mg | Oral |
| Subject | Tislelizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Tucidinostat | Small molecule | 20 mg | Oral |
| Subject | Tucidinostat | Small molecule | 30 mg | Oral |
| 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 |