15
Participants
Start Date
October 10, 2021
Primary Completion Date
December 31, 2023
Study Completion Date
September 30, 2025
Orelabrutinib
"Orelabrutinib will be given as 150 mg/d or 200 mg/d orally 72h after MTX infusion or MTX clearance, every 21 days for 6-8 cycles during combination induction treatment.~Daily Orelabrutinb with dose in last cycle of induction will be administered as maintenance treatment for up to 1 year or until disease progression, intolerable toxicity, death, informed consent withdrawal or lost of follow up (whichever occurs first)."
Rituximab
Rituximab 375 mg/m2 intravenous infusion d1, every 21 days for 6-8 cycles during combination induction treatment.
Methotrexate (MTX)
high-dose Methotrexate 3.5 g/m2 or 5g/m2 intravenous infusion (3h) d2, every 21 days for 6-8 cycels during combination induction treatment.
Dexamethasone
Dexamethasone 10-15 mg, iv, d1-4, every 21 days for 6-8 cycles during combination induction treatment.
Department of Hematology, Huashan Hospital, Fudan University, Shanghai
Huashan Hospital
OTHER