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NOT YET RECRUITING
NCT06901999
PHASE2

Methotrexate or Thiotepa Combined With R-CHOP and Orelabrutinib in CNSL Patients

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

Summary

This study is designed as an open-label, prospective, single-arm, single-center trial aimed at evaluating the efficacy and safety of MTX or Thiotepa combined with Orelabrutinib and standard chemotherapy regimens in the treatment of DLBCL patients with central nervous system involvement.

Official title: Efficacy and Safety of Methotrexate (MTX) or Thiotepa (for MTX-Intolerant Patients) Combined With R-CHOP and Orelabrutinib in the Treatment of Systemic DLBCL With Central Nervous System Involvement

Key Details

Gender

All

Age Range

14 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

23

Start Date

2025-04

Completion Date

2028-11

Last Updated

2025-03-30

Healthy Volunteers

No

Conditions

Interventions

DRUG

Orelabrutinib

150 mg qd po. D1-21, 6 cycles, 21 days per cycle For patients continue transplant, maitaining for 1 year follow-up; otherwise maintaining during 2 years of follow-up,unless disease progression or intolerable toxicity occurs.

DRUG

RCHOP+MTX or Thiotepa

rituximab: 375 mg/m2, D0; cyclophosphamide: 750 mg/m2, D1; doxorubicin: 50 mg/m2, D1; vincristine: 1.4 mg/m2, D1; prednisone: 100 mg, D1-5; MTX: 3.5 g/m2, D0; Thiotepa: 40 mg/m2, D3; Induction therapy, 6 cycles, 21 days a cycle