New treatment approach for primary central nervous system lymphoma
Official title: A Prospective, Single-Arm Clinical Study of Rituximab, Methotrexate, and Thiotepa (R-MT) Induction Followed by Etoposide and Cytarabine (EA) Consolidation for Primary Central Nervous System Lymphoma
Run by The First Hospital of Jilin University · NCT06946407 · Data updated 2026-11-12
This study is testing a new combination of treatments for people with newly diagnosed primary central nervous system lymphoma to see if it can help them respond better and stay healthy longer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 60 Years |
| Sex | All |
| Enrollment | 41 (estimated) |
| Sponsor | The First Hospital of Jilin University Academic / other |
| Drugs / interventions | rituximab, methotrexate, chemotherapy |
| Locations | 1 site (Changchun) |
| Status | Recruiting |
| Started | December 2, 2022 |
| Main results expected | December 1, 2027 |
| Study ends | December 1, 2029 |
| Registry record updated | April 27, 2025 |
| Trial ID | NCT06946407 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 60 years or younger with a confirmed diagnosis of diffuse large B-cell lymphoma localized to the central nervous system.
✕Probably not a fit
Patients with other active malignancies or severe comorbidities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates a novel treatment regimen combining rituximab, methotrexate, and thiotepa for induction therapy, followed by etoposide and cytarabine for consolidation in patients with newly diagnosed primary central nervous system lymphoma (PCNSL). The study aims to improve the overall response rate and prolong disease-free survival, particularly in younger patients. By assessing the safety, efficacy, and tolerability of this regimen, the trial seeks to optimize frontline therapy for PCNSL and address the high relapse rates associated with current treatments.
Why it matters
Potential benefit: If successful, this treatment could significantly improve remission rates and prolong survival for patients with primary central nervous system lymphoma.
How similar studies have gone: Preliminary data from similar approaches suggest potential improvements in treatment outcomes, although this specific regimen is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≤ 60 years, male or female * Histologically and immunohistochemically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) without prior treatment * No evidence of systemic lymphatic or hematopoietic involvement or other systemic disease, based on thorough physical examination and imaging/laboratory tests * Diagnosis meets criteria for Primary Central Nervous System Lymphoma (PCNSL) * Written informed consent obtained from the patient or their legal guardian * Voluntary agreement to participate in the study Exclusion Criteria: * Presence of another active malignancy * Known history of HIV infection or diagnosis of acquired immunodeficiency syndrome (AIDS) * Known allergy to any of the investigational drugs or their excipients * Any condition that, in the opinion of the investigator, may lead to early study termination, including but not limited to: * Severe comorbidities * Significant laboratory abnormalities * Serious social or family circumstances affecting safety or compliance
Where it's running
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Facility Name: The First Hospital of Jilin University
Changchun, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.