drugset / Trial / NCT05179733
The Efficacy and Safety of ZR2 Versus R-miniCHOP in the Treatment of Unfit or Frail de Novo Diffuse Large B-cell Lymphoma Patients Aged Older Than or Equal to 70 Years
Phase 3
Unknown
280 enrolled
Ruijin Hospital
Affiliated Hospital of Nantong University · collabChangzhou No.2 People's Hospital · collabFirst Affiliated Hospital of Fujian Medical University · collabFirst Hospital of China Medical University · collabHARBIN THE FIRST HOSPITAL · collabHenan Provincial People's Hospital · collabHuadong Hospital · collabHuai'an First People's Hospital · collabHunan Cancer Hospital · collabNational Naval Medical Center · collabNingbo No. 1 Hospital · collabNorthern Jiangsu People's Hospital · collabQilu Hospital of Shandong University · collabSUZHOU HONGCI HEMATOLOGY HOSPITAL · collabShandong Provincial Hospital · collabShanghai Fengxian District Central Hospital · collabSir Run Run Shaw Hospital · collabTHE FIRST AFFILIATED HOSPITAL · collabTaizhou Hospital · collabThe Affiliated Hospital of Xuzhou Medical University · collabThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · collabThe First Affiliated Hospital of Nanchang University · collabThe First Hospital of Jilin University · collabThe First People's Hospital of Changde City · collabThe First People's Hospital of Kunshan · collabThe Second Affiliated Hospital of Dalian Medical University · collabUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology · collabYANCHENG NO.1 PEOPLE'S HOSPITAL · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
A multicenter, prospective, randomized, open-label, controlled trial to evaluate the efficacy and safety of zanubrutinib, rituximab and lenalidomide (ZR2) versus rituximab combined with low-dose CHOP (R-miniCHOP) in the treatment of unfit or frail de novo diffuse large B-cell lymphoma patients aged older than or equal to 70 years
Timeline
- Start
- 2022-03-02
- Primary completion
- 2025-12-25
- Completion
- 2025-12-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclophosphamide | Other / unclassified | 400 mg/m2 | — |
| Comparator | Doxorubicin | Other / unclassified | 25 mg/m2 | — |
| Subject | Lenalidomide | Other / unclassified | 25 mg | Oral |
| Comparator | Prednisone | Other / unclassified | 40 mg/m2 | — |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Comparator | Vincristine | Small molecule | 1 mg | — |
| Subject | Zanubrutinib | Small molecule | 160 mg | Oral |