The aim of this study is to evaluate the efficacy and safety of the combination of thiotepa and pomalidomide in the treatment of relapsed/refractory (R/R) primary central nervous system lymphoma (PCNSL).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
thiotepa combined with pomalidomide: thiotepa 30mg/m2,intravenously guttae, on day 1; pomalidomide 12mg orally daily for 2 weeks. A chemotherapy cycle lasts for 3 weeks.
Jiangsu Province People's Hospital.
Nanjing, Jiangsu, China
RECRUITINGOverall Response Rate (ORR)
The proportion of subjects who achieves a best overall response of CR or PR.
Time frame: Baseline up to 2 years.
Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Time frame: Baseline up to 3 years.
2-year Progression-free Survival (PFS) rate
The proportion of patients who did not experience disease progression at 2 years.
Time frame: Baseline up to 2 years.
2-year Overall Survival(OS)rate
The proportion of patients who survived at 2 years.
Time frame: Baseline up to 3 years.
Duration of Response(DOR)
From the date that CR or PR are first occurred to the date of objective disease progression or death, whichever occurs first.
Time frame: Baseline up to 2 years.
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