Last updated: November 6, 2022
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Overall Status: Active - Recruiting
Phase
2
Condition
N/ATreatment
N/AClinical Study ID
NCT04481815
IR2020001238
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Histologically confirmed Primary Central Nervous System (CNS) lymphoma
- Age range 18-75 years old.
- Eastern Cooperative Oncology Group performance status 0 to 3.
- Previously untreated. Patients treated with steroid alone are eligible.
- Patient's who are not planned to undergo consolidation with autologous hematopoieticstem cell transplantation(HSCT).
- Measurable disease was defined as at least ≥1.0cm in short-diameter by MRI.
- Life expectancy of ≥ 3 months (in the opinion of the investigator).
- Participants must be able to understand and be willing to sign a written informedconsent document.
- Women of reproductive potential must agree to use highly effective methods of birthcontrol during the period of therapy and for 6 months after the last dose of the studydrug. Men who are sexually active must agree to use highly effective contraceptionduring the period of therapy and for 6 months after the last dose.
- Women of childbearing potential must have a negative plasma pregnancy test upon studyentry.
- Adequate renal function: Estimated glomerular filtration rate (GFR) or estimatedcreatinine clearance (CrCl) ≥ 50 mL/min;Serum creatinine ≤ 2 times the upper limit ofnormal.
- Adequate liver functions: Transaminase (AST/ALT) < 3 X upper normal value & Bilirubin < 2 X upper normal value.
- Adequate hematological function: hemoglobin ≥ 9 g/dL absolute neutrophil count (ANC) ≥ 1,500/μL and platelet count ≥ 75,000/μL.
Exclusion
Exclusion Criteria:
- Patient with systemic, non-CNS lymphoma metastatic to the CNS.
- Patient is concurrently using other approved or investigational antineoplastic agents.
- Presence of active hepatitis B virus(HBV) infection (HBsAg positive and HBV-DNA≥ 104),hepatitis C virus(HCV) infection, acquired and congenital immunodeficiency diseasesinclude but not limited to HIV.
- Patient is allergic to components of the study drug.
- Patient has an active concurrent malignancy requiring active therapy.
- Patient has significant abnormalities on screening electrocardiogram (EKG) and activeand significant cardiovascular disease such as uncontrolled or symptomaticarrhythmias, uncontrolled congestive heart failure, uncontrolled hypertension,valvular disease, pericarditis, or myocardial infarction within 6 months of screening.
- Patient is known to have an uncontrolled active systemic infection.
- Patient has a life-threatening illness, medical condition, or organ system dysfunctionthat, in the opinion of the investigator, could compromise the subject's safety or putthe study outcomes at undue risk.
- Women who are pregnant or nursing (lactating), where pregnancy is defined as a stateof a female after conception until the termination of gestation, confirmed by apositive plasma human chorionic gonadotropin(hCG) laboratory test of > 5 mIU/mL.
- The patient is unwell or unable to participate in all required study evaluations andprocedures.
- Drug abuse, medical, psychological or social conditions which may interfering withsubjects' participation in the study or evaluation of the results.
- Patients considered unsuitable to participate in the study by the researchers.
Study Design
Total Participants: 240
Study Start date:
October 01, 2020
Estimated Completion Date:
December 30, 2025
Study Description
Connect with a study center
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang 310009
ChinaActive - Recruiting
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