A Phase 2 interventional study of Rituximab and Lenalidomide in Primary Central Nervous System Lymphoma, sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-11-23.
Sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine · Phase 2, Interventional, and Treatment
It is a single arm, multicenter, phase 2 study to explore the efficacy and safety study of R2-MTX chemotherapy(Lenalidomide, Rituximab and Methotrexate)as first-line regimens in the treatment of newly diagnosed primary central nervous system lymphoma. Objective response rate is the primary endpoint.
This is a single arm, multicenter, phase 2 study designed to evaluate the efficacy and safety of rituximab, methotrexate and lenalidomide as first-line regimens in the treatment of newly primary central nervous system lymphoma. A total of 40 patients plan to participate in this study to receive a total 6 cycles of induction chemotherapy followed by 4 cycles of maintenance chemotherapy. Follow-ups should be taken up to the first 3 years. The primary endpoint is objective response rate (ORR) and secondary endpoint includes Progression free survival (PFS), overall survival (OS), and adverse events.
Second Affiliated Hospital, Zhejiang University, School of Medicine is the lead sponsor of 90 studies on the registry; 60 are open to participants now.
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Exclusion Criteria:
Experimental arm will be treated with R2-MTX regimen(Lenalidomide plus Rituximab and Methotrexate) for 6 cycles as initiate induction.If the patients achieved complete remission(CR)or partial remission(PR)with additional whole-brain radiotherapy(WBRT), they processed to R2 maintenance(Lenalidomide plus Rituximab) for 4 cycles.
Drug: Rituximab · Drug: Lenalidomide · Drug: Methotrexate
375mg/m2 intravenous infusion d1, every 3 weeks for 1 cycle, 6 cycles will be prescribed for induction therapy. 375mg/m2 intravenous infusion d1, every 8 weeks for 1 cycle, 4 cycles will be prescribed for maintenance therapy.
25mg orally d1-10 every 3 weeks for 1 cycle, 6 cycles will be prescribed for induction therapy. 25mg orally d1-14,d29-42 every 8 weeks for 1 cycle, 4 cycles will be prescribed for maintenance therapy.
3.5g/m2 intravenous infusion for 4 hours in d1, every 21 days for 1 cycle, 6 cycles will be prescribed.
Objective response rate(ORR)
The objective response rate is defined as the proportion of patients with a response of complete response(CR) or partial response(PR).
Time frame: At the end of Cycle 6 chemotherapy (each cycle is 21 days), assessed up to 18 weeks.
Progression free survival
From date of patients sign informed consent until the date of progression or death or the date of last follow-up time, whichever came first, assessed up to 3 years
Time frame: 3 years
Overall survival
From date of patients sign informed consent until the date of death or the date of last follow-up time, whichever came first, assessed up to 3 years
Time frame: 3 years
Treatment-related adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 1 year
Plan to share: No
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Rituximab · Lenalidomide · Methotrexate
Second Affiliated Hospital, Zhejiang University, School of Medicine