drugset / Trial / NCT04129710
A Trial to Compare Ibrutinib Versus Lenalidomide in Combination With MRE-chemotherapy for Adult Patients With Recurrent/Refractory Primary Central Nervous System Lymphoma (PCNSL)
Phase 2
Unknown
120 enrolled
Second Affiliated Hospital, School of Medicine, Zhejiang University
Cancer Hospital of Guangxi Medical University · collabFujian Medical University Union Hospital · collabNingbo Medical Center Lihuili Hospital · collabRenJi Hospital · collabRuijin Hospital · collabShandong Provincial Hospital · collabShanghai Tong Ren Hospital · collabSir Run Run Shaw Hospital · collabTaizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University · collabThe First Affiliated Hospital of Nanchang University · collabYinzhou Hospital Affiliated to Medical School of Ningbo University · collabZhejiang University · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a open-label，multicenter, randomised, three-arm, phase II efficacy and safety study of ibrutinib in combination with MRE(methotrexate,rituximab,etoposide)-chemotherapy versus lenalidomide in combination with MRE-chemotherapy given to adult patients who have recurrent/refractory primary central nervous system lymphoma (PCNSL)
Timeline
- Start
- 2020-01-01
- Primary completion
- 2023-12-31
- Completion
- 2025-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ibrutinib | Small molecule | 560 mg | — |
| Subject | Lenalidomide | Other / unclassified | 25 mg | Oral |
| Background | Etoposide | Small molecule | 250 mg/m2 | — |
| Background | Methotrexate | Small molecule | 3500 mg/m2 | — |
| Background | PEGylated recombinant human granulocyte colony | Protein / enzyme biologic | 100 ug/kg | Subcutaneous |
| Background | Rituximab | Monoclonal antibody | 375 mg/m2 | — |