This single-center, open, single-arm study aim to evaluate the efficacy and tolerability of a therapy introducing zanubrutinib on the basis of rituximab and methotrexate (MTX) \[or temozolomide (TMZ), if intolerant to MTX\] in treating patients newly diagnosed with primary CNS large B-cell lymphoma and intolerant to HSCT.
Participants will receive zanubrutinib in addition to first-line therapy consisting of rituximab and either MTX or TMZ. After treatment of 6 cycles with the new regimen, the patients achieving CR or PR would go on to receive zanubrutinib maintenance of 1 year (if tolerable).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
160 mg bid po, until disease progression, intolerance of drug toxicity or death, otherwise maintaining during the 1st year in 2 years of follow-up
375 mg/m\^2 ivgtt, D0 of each 28-day cycle
3.5 g/m\^2 ivgtt, D1 of each 28-day cycle
Ruijin Hospital
Shanghai, Shanghai Municipality, China
RECRUITING2-year Progression-Free Survival
Progression-free survival was defined as the time from the date of first treatment until the date of the first documented day of disease progression or relapse, according to 2014 Lugano criteria, or death from any cause, whichever occurred first.
Time frame: 2 years
Overall Response Rate (ORR)
The ORR is defined as percentage of participants with overall response including complete response (CR), unconfirmed complete response (CRu) and partial response (PR), on the basis of investigator assessments, according to the 2005 Response Criteria of the International Primary CNS Lymphoma Collaborative Group (IPCG).
Time frame: Baseline up to data cut-off (up to approximately 2 years)
Complete Response (CR) Rate
The CR rate is defined as the proportion of patients with CR/CRu according to the 2005 Response Criteria of the International Primary CNS Lymphoma Collaborative Group (IPCG).
Time frame: Baseline up to data cut-off (up to approximately 2 years)
Overall Survival (OS)
Overall survival is defined as the time from the date of first treatment to the date of death from any cause.
Time frame: Baseline up to data cut-off (up to approximately 2 years)
Adverse Events
Any harmful reaction that occurs during the treatment of a disease according to the normal usage and dosage of a drug, which is unrelated to the purpose of treatment.
Time frame: Baseline up to data cut-off (up to approximately 2 years)
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150 mg/m\^2 ivgtt, D1-D5 of each 28-day cycle