A Phase 1/2 interventional study of Pomalidomide and Rituximab in PCNSL, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-08-15.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Phase 1/2, Interventional, and Treatment
This is a prospective, multicenter, single-arm, open Phase Ib/II clinical study to explore the safety and efficacy of pomadomide in combination with rituximab and methotrexate (RPM) in newly diagnosed primary central nervous system lymphoma (PCNSL) subjects. The Phase I study is a dose escalation study, in which rituximab and methotrexate are fixed doses, and pomadomide is set into 3 dose groups: 3mg/d, 4mg/d and 5mg/d. In strict accordance with the "3+3" dose escalation principle, 3-6 subjects are to be recruited in each dose group, and each subject is to be observed for 1 cycle after treatment to determine MTD. Phase II study: RP2D is planned to be determined based on the Phase Ib study, with an additional 25 active participants enrolled to further evaluate efficacy and safety. Subjects with initial treatment of PCNSL who met the inclusion/exclusion criteria were screened, and after signing the informed consent letter, they received 4 courses of PRM regimen. The patients achieving CR or PR were consolidated by autologous transplantation consolidation regimen or the original regimen for 2 courses, and then were given pomadomide maintenance therapy for 12 cycles. Follow-ups should be taken up to the first 3 years.
Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Experimental arm will be treated with PRM regimen (pomadomide in combination with rituximab and methotrexate) for 4 cycles as initiate induction. If the patients achieved complete remission(CR)or partial remission(PR), They would be consolidated by autologous transplantation consolidation regimen or the original regimen for additional 2 courses, and then were given pomadomide maintenance therapy for 12 cycles.
Drug: Pomalidomide · Drug: Rituximab · Drug: Methotrexate
3-5mg d1-d14 for 4-6 cycles, every 21 days as induction/consolidation chemotherapy, Then 3-5mg d1-d14 for 12 cycles, every 28 days as maintenance treatment.
375mg/m2 intravenous infusion d1, every 3 weeks for 1 cycle, 4-6 cycles will be prescribed.
3.5g/m2 intravenous infusion for 4 hours in d1, every 21 days for 1 cycle, 4-6 cycles will be prescribed.
MTD
MTD of pomalidomide when given in combination with rituximab and methotrexate determined by dose-limiting toxicities graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Time frame: 21days
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: 4 cycles of threatment
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: Time from registration to progression or death due to PCNSL, assessed up to 2 years
Overall 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: Time from registration to death due to any cause, assessed up to 3 years
pomalidomide levels in the CNS
Based on pomalidomide levels in CSF at different time points
Time frame: Up to day 3 of course 2
pomalidomide levels in the Blood
Based on pomalidomide levels in blood at different time points
Time frame: Up to day 3 of course 2
Plan to share: No
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Second Affiliated Hospital, School of Medicine, Zhejiang University