New treatment approach for primary central nervous system lymphoma
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 41 (estimated) |
| Ages | N/A to 60 Years |
| Sex | All |
| Sponsor | The First Hospital of Jilin University Academic / other |
| Drugs / interventions | rituximab, methotrexate, chemotherapy |
| Locations | 1 site (Changchun) |
| Trial ID | NCT06946407 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with other active malignancies or severe comorbidities may not benefit from this study.
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 performed: Preliminary data from similar approaches suggest potential improvements in treatment outcomes, although this specific regimen is novel.
Eligibility criteria
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 this trial is running
Changchun
- Facility Name: The First Hospital of Jilin University — Changchun, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.