In view of the synergistic effects of rituximab, zanubrutinib, and lenalidomide and severe complications caused by current standard chemotherapy regimens in Patients for primary or secondary CNS lymphoma, we intend to conduct a prospective clinical study to evaluate the efficacy and toxicity of Rituximab, Zanubrutinib in combination with Lenalidomide. Besides, the efficacy of Zanubrutinib or Lenalidomide in maintenance was also compared.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Induction therapy: Rituximab 375 mg / m2, day 1, Zanubrutinib 160 mg bid, orally, Lenalidomide 25mg QD, orally on day 1-21, 28 days as a course of treatment, 8 courses of treatment.
Maintenance therapy: Lenalidomide: 25mg qd (adjusted according to hectogram condition) or Zanubrutinib 160 mg bid. Continuously use for 2 years or until disease progression
Maintenance therapy: Lenalidomide: 25mg qd (adjusted according to hectogram condition) . Continuously use for 2 years or until disease progression
Henan cancer hospital
Zhengzhou, Henan, China
RECRUITINGOverall response rate
To evaluate the overall response rate of ZR2 in the treatment of CNS Lymphoma
Time frame: at the end of 8 cycles of induction therapy (each cycle is 28 days)
Overall response rate
Time frame: at the end of 4 cycles of induction therapy (each cycle is 28 days) and 1 year of maintenance therapy
Progression-free survival (PFS) rate
Time frame: at the end of 8 cycles of induction therapy (each cycle is 28 days), 1 year and 2 year of maintenance therapy
Overall survival(OS)rate
Time frame: at the end of 8 cycles of induction therapy (each cycle is 28 days), 1 year and 2 year of maintenance therapy
Treatment related adverse events
Time frame: at the end of 8 cycles of induction therapy (each cycle is 28 days), 1 year and 2 year of maintenance therapy
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