drugset / Trial / NCT05351346
Genotype-guided Treatment in DLBCL
Phase 3
Unknown
1100 enrolled
Ruijin Hospital
Affiliated Cancer Hospital of Harbin Medical University · collabAffiliated Hospital of Guilin Medical College · collabAffiliated Hospital of Nantong University · collabAffiliated Zhongshan Hospital of Dalian University · collabAir Force Military Medical University, China · collabBeijing Hospital · collabBeijing Tongren Hospital · collabCancer Hospital Affiliated to Xinjiang Medical University · collabCentral South University · collabChina-Japan Friendship Hospital · collabFifth Affiliated Hospital of Guangzhou Medical University · collabFirst Affiliated Hospital Xi'an Jiaotong University · collabFirst Affiliated Hospital of Chongqing Medical University · collabFirst Affiliated Hospital of Harbin Medical University · collabFudan University · collabFujian Medical University Union Hospital · collabGansu Cancer Hospital · collabHarbin Institute of Hematology · collabHenan Cancer Hospital · collabHunan Cancer Hospital · collabInstitute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Pekcing Union Medical College · collabLanZhou University · collabLiaoning Cancer Hospital & Institute · collabPeking University Third Hospital · collabQilu Hospital of Shandong University · collabRenJi Hospital · collabSecond Affiliated Hospital of Xi'an Jiaotong University · collabShandong Cancer Hospital and Institute · collabShanghai Jiao Tong University Affiliated Sixth People's Hospital · collabShanxi Province Cancer Hospital · collabThe Affiliated Hospital of Xuzhou Medical University · collabThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · collabThe First Affiliated Hospital of Anhui Medical University · collabThe First Affiliated Hospital of Anhui Medical University North District · collabThe First Affiliated Hospital of Guangzhou Medical University · collabThe First Affiliated Hospital of Nanchang University · collabThe First Affiliated Hospital of Soochow University · collabThe First Affiliated Hospital of University of Science and Technology of China · collabThe First Affiliated Hospital of Xiamen University · collabThe First Affiliated Hospital of Zhengzhou University · collabThe First Hospital of Jilin University · collabThe First People's Hospital of Yunnan · collabThe Second Affiliated Hospital of Dalian Medical University · collabThe Second Hospital of Anhui Medical University · collabThe Third Affiliated Hospital of Wenzhou Medical University · collabTongji Hospital · collabUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology · collabWest China Hospital · collabXinhua Hospital, Shanghai Jiao Tong University School of Medicine · collabYantai Yuhuangding Hospital · collabYunnan Cancer Hospital · collabZhongda Hospital · collabZhujiang Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
A multicenter, prospective, randomized, open-label, controlled trial to evaluate the efficacy and safety of genotype-guided targeted agents plus rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP-X) versus rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with diffuse large B-cell lymphoma
Timeline
- Start
- 2022-06-01
- Primary completion
- 2026-06-01
- Completion
- 2026-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Decitabine | Small molecule | 10 mg/m2 | Intravenous |
| Subject | Lenalidomide | Other / unclassified | 25 mg | Oral |
| Subject | Orelabrutinib | Small molecule | 150 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 | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Background | Vincristine | Small molecule | 1.4 mg/m2 | Intravenous |