Last updated: April 18, 2022
Sponsor: Ruijin Hospital
Overall Status: Active - Recruiting
Phase
3
Condition
Lymphoma
Treatment
N/AClinical Study ID
NCT05334238
PCNSL-001
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Men and women, aged 18-65;
- Primary CNS lymphoma patients with CR were evaluated in the final stage of first-linetherapy, and the virus-infected patients were balanced between the experimental andcontrol groups;
- Laboratory tests (blood routine, liver and kidney function) meet the followingrequirements: A) Blood routine examination: white blood cell count ≥3.0×109/L, absolute neutrophilcount ≥1.5×10^9/L, hemoglobin ≥90g/L, platelet ≥75×10^9/L; B) Liver function:transaminase ≤2.5× upper limit of normal value, bilirubin ≤1.5× upper limit of normalvalue; C) Renal function: serum creatinine 44-133 mmol/L;
- Participants' ECOG physical status score was 0-2; The subject or his/her legalrepresentative must provide written informed consent prior to conducting a specialstudy examination or procedure.
Exclusion
Exclusion Criteria: Presence of any of the following criteria will exclude a patient from enrollment:
- Uncontrolled cardio- and cerebro-vascular disease, blood clotting disorders,connective tissue diseases, serious infectious diseases and other diseases
- Laboratory measures meet the following criteria at screening (unless caused bylymphoma):
- Neutrophils<1.5×10^9/L
- Platelets<80×10^9/L (Platelets<50×10^9/L in case of bone marrow involvement)
- ALT or AST is 2 times higher than the upper limits of normal (ULN), AKP andbilirubin are 1.5 times higher than the ULN.
- Creatinine is 1.5 times higher than the ULN or eGFR is lower than 40ml/min/1.73m^2 (according to Cockcroft-Gault Equation or MDRD Equation).
- HIV-infected patients
- Left ventricular ejection fraction<50%
- Patients with HbsAg positive are required to have HBV DNA<1.0×10^3 IU/ml beforeentering the group. In addition, if the patient is HBsAg negative but HBcAb positive (regardless of HBsAb status), HBV DNA test is also required, and HBV DNA<1.0×10^3IU/ml is required before entering the group.
- Other anti-tumor treatments (lymphoma or other types of tumors) are currently inprogress.
- Patients with psychiatric disorders or patients who are known or suspected to beunable to fully comply with the study protocol
- History of stroke or intracranial hemorrhage within 6 months prior to start of therapy
- Inability to swallow capsules or presence of diseases that significantly affectgastrointestinal function, such as malabsorption syndrome, post-bariatric surgery,inflammatory bowel disease and complete or incomplete intestinal obstruction
- Other medical conditions determined by the researchers that may affect the study
Study Design
Total Participants: 174
Study Start date:
December 01, 2021
Estimated Completion Date:
May 30, 2025
Study Description
Connect with a study center
Ruijin Hospital
Shanghai, Shanghai 20025
ChinaActive - Recruiting

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