Zanubrutinib Combined With Rituximab and Chemotherapy for Newly-Diagnosed PCNSLBCL Patients Intolerant to HSCT

Sponsor
Ruijin Hospital
Study ID
NCT05896007
Phase
PHASE2
Status
Unknown

Conditions

  • PCNSL

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Zanubrutinib — 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
  • Rituximab — DRUG
    375 mg/m\^2 ivgtt, D0 of each 28-day cycle
  • Methotrexate — DRUG
    3.5 g/m\^2 ivgtt, D1 of each 28-day cycle
  • Temozolomide — DRUG
    150 mg/m\^2 ivgtt, D1-D5 of each 28-day cycle

Study Details

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.

Key Dates

Start date
Jul 13, 2023
Status verified
Sep 2023
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
29 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ZR-chemo
    Drug: Zanubrutinib, Rituximab and MTX (or TMZ, if intolerant to MTX)

Primary Outcome Measure

2-year Progression-Free Survival [ Time Frame: 2 years ]

Central Contacts