Status:
UNKNOWN
Rituximab Plus Methotrexate With or Without Lenalidomide in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
PCNSL
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
It is a multicenter, open-Label, randomised phase 2 study to compare the efficacy and safety study of R2-MTX chemotherapy（Lenalidomide, Rituximab and Methotrexate）with R-MTX chemotherapy（Rituximab and...
Detailed Description
This is a multicenter, open-Label, randomised phase 2 study designed to evaluate the efficacy and safety of rituximab plus methotrexate with or without lenalidomide as first-line regimens in the treat...
Eligibility Criteria
Inclusion
- 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 hematopoietic stem 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 informed consent document.
- Women of reproductive potential must agree to use highly effective methods of birth control during the period of therapy and for 6 months after the last dose of the study drug. Men who are sexually active must agree to use highly effective contraception during the period of therapy and for 6 months after the last dose.
- Women of childbearing potential must have a negative plasma pregnancy test upon study entry.
- Adequate renal function: Estimated glomerular filtration rate (GFR) or estimated creatinine clearance (CrCl) ≥ 50 mL/min;Serum creatinine ≤ 2 times the upper limit of normal.
- 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
- 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 diseases include 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 active and significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, 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 dysfunction that, in the opinion of the investigator, could compromise the subject's safety or put the study outcomes at undue risk.
- Women who are pregnant or nursing (lactating), where pregnancy is defined as a state of a female after conception until the termination of gestation, confirmed by a positive plasma human chorionic gonadotropin(hCG) laboratory test of \> 5 mIU/mL.
- The patient is unwell or unable to participate in all required study evaluations and procedures.
- Drug abuse, medical, psychological or social conditions which may interfering with subjects' participation in the study or evaluation of the results.
- Patients considered unsuitable to participate in the study by the researchers.
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT04481815
Start Date
October 1 2020
End Date
December 30 2025
Last Update
November 8 2022
Active Locations (1)
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1
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310009