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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Induction Chemotherapy: Orelabrutinib, 150mg/d continuous oral administration (3 weeks/cycle, total 6 cycles). Maintenance Treatment: Orelabrutinib, 150mg/d continuous oral administration (28d/cycle).
Induction Chemotherapy: Pemetrexed, 500mg/m2, Intravenous administration on day 5 of each 3-week cycle (Total 6 cycles).
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
Zhengzhou, Henan, China
RECRUITINGobjective response rate
the total proportion of patients with complete response (CR) and partial response (PR)
Time frame: every 6 weeks from the day of the first cycle of induction chemotherapy treatment (each cycle is 21 days) and every 8 weeks from the day of the first cycle of maintenance treatment to 5 years after last patient's enrollment (each cycle is 28 days)
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
Time frame: every 6 weeks from the day of the first cycle of induction chemotherapy treatment (each cycle is 21 days) and every 8 weeks from the day of the first cycle of maintenance treatment to 5 years after last patient's enrollment (each cycle is 28 days)
overall survival
from date of first day of treatment to the date of death by any cause
Time frame: every 6 weeks from the day of the first cycle of induction chemotherapy treatment (each cycle is 21 days) and every 8 weeks from the day of the first cycle of maintenance treatment to 5 years after last patient's enrollment (each cycle is 28 days)
The incidence of grade 3-4 adverse events
the incidence of grade 3 or 4 adverse events (based on NCI CTC-AE v5.0)
Time frame: up to 5 years
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