Zanubrutinib Combined With Rituximab and Chemotherapy for Newly-Diagnosed PCNSLBCL Patients Intolerant to HSCT
NCT05896007 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29
Last updated 2023-09-05
Summary
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.
Conditions
Interventions
- DRUG
-
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
- DRUG
-
375 mg/m\^2 ivgtt, D0 of each 28-day cycle
- DRUG
-
Methotrexate
3.5 g/m\^2 ivgtt, D1 of each 28-day cycle
- DRUG
-
150 mg/m\^2 ivgtt, D1-D5 of each 28-day cycle
Sponsors & Collaborators
-
Ruijin Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-07-13
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
Countries
- China
Study Locations
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