This is a prospective single arm, phase II clinical trial to observe the efficacy and safety of orelabrutinib combined with pemetrexed in the treatment for patients with relapsed/refractory central nervous system lymphoma.
Age between 18 to 75 years old (including 18 and 75)
Diagnosed as diffuse large B-cell lymphoma; Recurrence or progression of central nervous system disease confirmed by imaging ± tissue biopsy pathology or cerebrospinal fluid flow cytometry; Secondary central nervous system lymphoma can also be admitted when the systemic disease is well controlled
Having at least one measurable lesions
World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2 ( ECOG 3 due to tumors can be included after being fully assessed by the investigator)
Poor peripheral disease control of secondary central nervous system lymphoma
Patients used pemetrexed or orelabrutinib in the past
Active malignant tumor need be treated at the same time
Other malignant tumor history
Single group
ICP-022
DrugInduction Chemotherapy: Orelabrutinib, 150mg/d continuous oral administration (3 weeks/cycle, total 6 cycles). Maintenance Treatment: Orelabrutinib, 150mg/d continuous oral administration (28d/cycle).
Pemetrexed
DrugInduction Chemotherapy: Pemetrexed, 500mg/m2, Intravenous administration on day 5 of each 3-week cycle (Total 6 cycles).
objective response rate
the total proportion of patients with complete response (CR) and partial response (PR)
progression-free survival
the total proportion of patients with no progression from date of the first day of treatment to the date of confirmed progressive disease or death which one occurs first
overall survival
from date of first day of treatment to the date of death by any cause
The incidence of grade 3-4 adverse events
the incidence of grade 3 or 4 adverse events (based on NCI CTC-AE v5.0)
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