Zanubrutinib Combined With Rituximab and Chemotherapy for Newly-Diagnosed Primary Central Nervous System Large B-Cell Lymphoma Patients Intolerant to Haematopoietic Stem Cell Transplantation

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This single-center, open, single-arm study aim to evaluate the efficacy and tolerability of a therapy introducing zanubrutinib on the basis of rituximab and methotrexate (MTX) \[or temozolomide (TMZ), if intolerant to MTX\] in treating patients newly diagnosed with primary CNS large B-cell lymphoma and intolerant to HSCT.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:

• 18 to 80 years old;

• Histopathologically confirmed CD20 positive primary large B-cell lymphoma of the central nervous system (CNS) or primary vitreoretinal lymphoma according to the 5th edition of the World Health Organization (WHO) Classification of Haematolymphoid Tumours \[primary large B-cell lymphoma of the CNS previously named as primary diffuse large B-cell lymphoma (DLBCL) of the CNS in the revised 4th edition\];

• Life expectancy of \> 3 months (in the opinion of the investigator);

• Creatinine Clearance Rate (CCR) ≥ 50 mL/min or estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL/(min·1.73 m\^2);

• International Normalized Ratio (INR) ≤ 1.5 and activated Partial Thromboplastin Time (aPTT) ≤ 1.5 times the upper limit of normal;

• Left Ventricular Ejection Fraction (LVEF) ≥ 50%;

• Agreeing to provide written informed consent prior to any special examination or procedure for the research on their own or legal representative.

Locations
Other Locations
China
Ruijin Hospital
RECRUITING
Shanghai
Contact Information
Primary
Weili Zhao, Doctor
zwl_trial@163.com
+86-64370045
Backup
Li Wang
wl_wangdong@126.com
+86-64370045
Time Frame
Start Date: 2023-07-13
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 29
Treatments
Experimental: ZR-chemo
Drug: Zanubrutinib, Rituximab and MTX (or TMZ, if intolerant to MTX)
Sponsors
Leads: Ruijin Hospital

This content was sourced from clinicaltrials.gov

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