This study aims to observe and explore the efficacy and safety of Rituximab-Methotrexate-Temozolomide-Thiotepa (RMTT) regimen as first-line therapy for primary central nervous system diffuse large B-cell lymphomas(PCNS DLBCL)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Rituximab: 375 mg/m2 intravenously on day 3,7; Methotrexate: 1.5-3.5 g/m2 intravenously on day 1,14(≤65 ,3.5g/m2;\>65,1.5g/m2); Temozolomide 150 mg/m2 on days 3-7; Thiotepa:40 mg/m2 intravenously on day 17。 Treatment will be given for 4 cycles(28 days for each cycle), and patients who achieve a CR or better can choose to undergo ASCT or WBRT(23.4Gy).
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGComplete Remission Rate(CRR)
The proportion of subjects who achieves a best overall response of CR
Time frame: Up to 16 weeks
Overall Response Rate (ORR)
The proportion of subjects who achieves a best overall response of CR or PR.
Time frame: Up to 16 weeks
Progression-Free Survival(PFS)
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first
Time frame: Up to 2 years
overall survival(OS)
The overall survival time refers to the time from therapy to death due to any cause.
Time frame: 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: From date of first day of treatment until 30 day after last treatment
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