This is a multicenter prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of sequential treatment regimens with RO-MTX after pomalidomide, orelabrutinib, rituximab (POR) in newly-diagnosed primary central nervous system lymphoma, and explore the feasibility of chemo-free treatment in PCNSL. The primary objective was the overall response rate (ORR; defined as partial response \[PR\] or better) after 4 cycles of POR.
There are 2 sections of this trial. Step1: the patients will be treated with 4 cycles of POR regimen （Pomalidomide 4mg d1-d14, Orelabrutinib 150mg d1-d21, Rituximab 375mg/m2 d1, 21 days per cycle). The response will be evaluated every 2 cycles. The patients with PD will drop out of the study. Step2: Patients with CR/PR/SD after 4 cycles of POR treatment will be treated with 2 cycles of RO-MTX regimen（methotrexate 3.5g/m2 civ d1, Orelabrutinib 150mg d1-d21, Rituximab 375mg/m2 d1, 21 days per cycle). After 6 cycles of induction therapy, all patients were followed for survival data every 12 week until disease progression, disease recurrence, death, or study termination. Patients with progression were also followed up for survival data as above. Overall survival will be followed up to 3 years after the last subject entered the study. Establishing the feasibility of chemo-free treatment in primary central nervous system lymphoma will provide the foundation for a larger study of efficacy and long-term outcomes of chemo-free therapy for patients with PCNSL.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Orelabrutinib will be given as 150mg orally d1-d21 for 6 cycles,every 21 days for 1 cycle.
Pomalidomide will be given as 4mg d1-d14 for 4 cycles,every 21 days for 1 cycle.
Rituximab 375mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 6 cycles will be prescribed as protocol
Beijing TianTan Hospital
Beijing, Beijing Municipality, China
RECRUITINGSanbo Brain Hospital Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGPeking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGoverall response rate
ORR is defined as the proportion of patients with a best response of CR, CRu or PR
Time frame: The ORR will be evaluated at 82 days from the POR treatment, which means after 4 cycles and each cycle is 21 days
overall response rate
ORR is defined as the proportion of patients with a best response of CR, CRu or PR
Time frame: The ORR will be evaluated at 126 days from date of signing the informed consent , which means after 6 cycles and each cycle is 21 days
complete response rate
CR is defined as the proportion of patients with a best response of CR or CRu
Time frame: The ORR will be evaluated at 82 days from the POR treatment, which means after 4 cycles and each cycle is 21 days
2 years progression-free survival
2 years progression-free survival was calculated from the date of therapy until death from lymphoma or 2-year follow-up without relapsing
Time frame: From date of signing the informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
2 years overall survival
2 years progression-free survival was calculated from the date of therapy until death from lymphoma or 2-year follow-up alive
Time frame: From date of signing the informed consent until the date of death from any cause, whichever came first, assessed up to 2 years
The occurrence of adverse events and serious adverse events
Adverse events will be graded by the investigator according to the NCI-CTCAE Version 5.0.
Time frame: during follow-up, up to 2 years
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methotrexate 3.5g/m2 civ d1/cycle5-6