Zanubrutinib Combined With Rituximab and Chemotherapy for Newly-Diagnosed PCNSLBCL Patients Intolerant to HSCT
NCT ID: NCT05896007
Last Updated: 2023-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
29 participants
INTERVENTIONAL
2023-07-13
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ZR-chemo
Drug: Zanubrutinib, Rituximab and MTX (or TMZ, if intolerant to MTX)
Zanubrutinib
160 mg bid po, until disease progression, intolerance of drug toxicity or death, otherwise maintaining during the 1st year in 2 years of follow-up
Rituximab
375 mg/m\^2 ivgtt, D0 of each 28-day cycle
Methotrexate
3.5 g/m\^2 ivgtt, D1 of each 28-day cycle
Temozolomide
150 mg/m\^2 ivgtt, D1-D5 of each 28-day cycle
Interventions
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Zanubrutinib
160 mg bid po, until disease progression, intolerance of drug toxicity or death, otherwise maintaining during the 1st year in 2 years of follow-up
Rituximab
375 mg/m\^2 ivgtt, D0 of each 28-day cycle
Methotrexate
3.5 g/m\^2 ivgtt, D1 of each 28-day cycle
Temozolomide
150 mg/m\^2 ivgtt, D1-D5 of each 28-day cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Known Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection (HBV infection refers to HBV-DNA \> detectable limit);
* With acquired or congenital immunodeficiency;
* With congestive heart failure in 6 months before enrollment, New York Heart Association (NYHA) heart function class III or IV, or LVEF \< 50%;
* Known to be allergic to the test drug ingredients;
* Diagnosed with or being treated for malignancy other than lymphoma;
* With severe infection;
* Substance abuse, medical, psychological, or social conditions that may interfere with the subjects' participation in the study or evaluation of the study results;
* Deemed unsuitable for the group.
18 Years
80 Years
ALL
Yes
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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Zhao Weili
Professor
Locations
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Ruijin Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Zana
Identifier Type: -
Identifier Source: org_study_id
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