drugset / Trial / NCT06647940
Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL Patients（Rocket Trial）
Phase 2
Recruiting
39 enrolled
Sun Yat-sen University
Dongguan People's Hospital · collabFifth Affiliated Hospital of Guangzhou Medical University · collabFifth Affiliated Hospital, Sun Yat-Sen University · collabFirst Affiliated Hospital of Shantou University Medical College · collabFirst People's Hospital of Zhaoqing · collabGansu Cancer Hospital · collabGuangdong Provincial Hospital of Traditional Chinese Medicine · collabGuangzhou First People's Hospital · collabSecond Affiliated Hospital of Guangzhou Medical University · collabShenzhen People's Hospital · collabSouthern Medical University, China · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of orelabrutinib combined with the R-CHOP (rituximab, cyclophosphamide, vincristine, doxorubicin, and prednisone) regimen as first-line treatment in CD5-positive diffuse large B-cell lymphoma (DLBCL) patients.
Timeline
- Start
- 2024-11-01
- Primary completion
- 2026-11-01
- Completion
- 2027-03-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Orelabrutinib | Small molecule | 150 mg | Oral |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Doxorubicin | Other / unclassified | — | — |
| Background | Prednisone | Other / unclassified | — | — |
| Background | Rituximab | Monoclonal antibody | — | — |
| Background | Vincristine | Small molecule | — | — |