Rituximab Plus Methotrexate With or Without Lenalidomide in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma

STATUS

Recruiting
End date

Dec 30, 2025
participants needed

240
sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

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Updated on 19 February 2024

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platelet count

methotrexate

absolute neutrophil count

renal function

measurable disease

neutrophil count

glomerular filtration rate

stem cell transplantation

rituximab

estimated creatinine clearance

cell transplantation

lymphoma

lenalidomide

kidney function tests

renal function test

nervous

primary cns lymphoma

nervous system

Summary

It is a multicenter, open-Label, randomised phase 2 study to compare the efficacy and safety study of R2-MTX chemotherapyLenalidomide, Rituximab and Methotrexatewith R-MTX chemotherapyRituximab and Methotrexate as first-line regimens in the treatment of newly diagnosed primary central nervous system lymphoma.2-year Progression free survival (PFS) is the primary endpoint.

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 treatment of primary central nervous system lymphoma. A total of 240 patients plan to participate in this study to receive a total 6 cycles of induction chemotherapy followed by 4 cycles of maintenance chemotherapy. Follow-ups should be taken up to the first 3 years.The primary endpoints were 2-year PFS rate and and secondary endpoints including objective response rate (ORR), PFS, overall survival (OS), and adverse events.

Details

Condition	PCNSL
Age	18-75 years
Treatment	Rituximab, Lenalidomide, Methotrexate
Clinical Study Identifier	NCT04481815
Sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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 hematopoietic stem cell transplantationHSCT
	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/L and platelet count 75,000/L
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 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

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Rituximab Plus Methotrexate With or Without Lenalidomide in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma