Completed

Efficacy and Safety Study of Rituximab, Methotrexate and Lenalidomide Chemotherapy（R2-MTX） in Newly Diagnosed Primary Central Nervous System Lymphoma：a Single Arm, Multicenter, Phase 2 Study

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What is being tested

Rituximab

+ Lenalidomide

+ Methotrexate

Drug
Who is being recruted

From 18 to 75 Years
+25 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: January 2020
See protocol details

Summary

Principal SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2020

Actual date on which the first participant was enrolled.

This is a single arm, multicenter, phase 2 study designed to evaluate the efficacy and safety of rituximab, methotrexate and lenalidomide as first-line regimens in the treatment of newly primary central nervous system lymphoma. A total of 40 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 endpoint is objective response rate (ORR) and secondary endpoint includes Progression free survival (PFS), overall survival (OS), and adverse events.

Official TitleEfficacy and Safety Study of Rituximab, Methotrexate and Lenalidomide Chemotherapy（R2-MTX） in Newly Diagnosed Primary Central Nervous System Lymphoma：a Single Arm, Multicenter, Phase 2 Study
NCT04934579
Principal SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

17 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

13 inclusion criteria required to participate
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.
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12 exclusion criteria prevent from participating
Patient is known to have an uncontrolled active systemic infection.
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.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Experimental arm will be treated with R2-MTX regimen(Lenalidomide plus Rituximab and Methotrexate) for 6 cycles as initiate induction.If the patients achieved complete remission（CR）or partial remission（PR）with additional whole-brain radiotherapy（WBRT）, they processed to R2 maintenance(Lenalidomide plus Rituximab) for 4 cycles.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, ChinaOpen 2nd Affiliated Hospital, School of Medicine, Zhejiang University in Google Maps
CompletedOne Study Center