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ACTIVE NOT RECRUITING
NCT05036577
PHASE1

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

Sponsor: Huashan Hospital

View on ClinicalTrials.gov

Summary

This is a single arm, single center, open label pilot study of Orelabrutinib combined with Rituximab, high-dose (HD) Methotrexate and Dexamethasone in newly-diagnosed primary central nervous system lymphpoma (PCNSL). The purpose is to evaluate the safety and to find the optimal dose of Orelabrutinib and Methotrexate in this combination treatment for newly-diagnosed PCNSL patients.

Official title: A Dose-escalating Pilot Study of Orelabrutinib in Combination With Rituximab, Methotrexate and Dexamethasone for Newly-diagnosed Primary Central Nervous System Lymphoma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2021-10-10

Completion Date

2025-09-30

Last Updated

2024-10-18

Healthy Volunteers

No

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.

Locations (1)

Department of Hematology, Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China