Status and phase
Conditions
Treatments
About
Secondary central nervous system lymphoma (SCNSL) occurred in about 5% of patients with diffuse large B-cell lymphoma (DLBCL). The prognosis of SCNSL is very poor. A number of retrospective studies have shown that the median overall survival (mOS) since the diagnosis of CNSL is only 2.5-3.5 months, and the 2-year OS rate is only 20%. At present, there is no consensus on the treatment of SCNSL, and new therapeutic strategies are urgently needed. Zanubrutinib is a new second-generation BTK inhibitor, which has showed good efficacy and safety in a variety of B-NHL. Zanubrutinib has showed good blood-brain barrier permeability in preclinical studies. This study attempts to evaluate the efficacy and safety of zanubrutinib combined with rituximab and high-dose methotrexate in the treatment of SCNSL in patients with DLBCL.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Men and women ≥ 18, and ≤75 years of age
Histologically documented systemic diffuse large B-cell lymphoma(DLBCL)
Central nervous system (CNS) relapse (meningeal or /and intraparenchymal) with or without systemic lymphoma manifestations
All patients need to have received at least one and ≤4 lines of prior therapy systemic lymphoma directed therapy.
ECOG performance score 0-3
Participants must have adequate bone marrow and organ function shown by:
Expected survival greater than 3 months
Did not receive targeting agents within 10 days or receive chemortherapy, radiotherapy, or monoclonal antibody within 3 weeks
Woman of reproductive potential must agree to use highly effective methods of birth control during the period of therapy and for 30 days after the last dose of the study drug. Men who are sexually active must agree to use highly effective contraception during the period of therapy and for 3 months after the last dose
Ability of participants or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
45 participants in 1 patient group
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Central trial contact
Lijuan Deng
Data sourced from clinicaltrials.gov
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