A Dose-escalating Pilot Study of Orelabrutinib for Newly-diagnosed PCNSL

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

October 10, 2021

Primary Completion Date

December 31, 2023

Study Completion Date

September 30, 2025

Conditions
Primary Central Nervous System Lymphoma
Interventions
DRUG

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)."

DRUG

Rituximab

Rituximab 375 mg/m2 intravenous infusion d1, every 21 days for 6-8 cycles during combination induction treatment.

DRUG

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.

DRUG

Dexamethasone

Dexamethasone 10-15 mg, iv, d1-4, every 21 days for 6-8 cycles during combination induction treatment.

Trial Locations (1)

200040

Department of Hematology, Huashan Hospital, Fudan University, Shanghai

All Listed Sponsors
lead

Huashan Hospital

OTHER