NCT06946407Recruiting
Rituximab, Methotrexate, and Tepadina Induction Followed by Etoposide and Cytarabine Consolidation in 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
Source: ClinicalTrials.gov · Last updated 27 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
High-dose methotrexate (HD-MTX) remains the foundation of treatment for primary central nervous system lymphoma (PCNSL), but outcomes are suboptimal. The addition of rituximab has shown mixed results, partly due to limited blood-brain barrier penetration. The MATRix regimen (rituximab, HD-MTX, cytarabine, thiotepa) has improved survival but is associated with significant toxicity. Consolidation therapy is recommended after induction, but there is no standard approach. Preliminary data suggest that etoposide and cytarabine (EA) consolidation after rituximab-HD-MTX induction may offer improved tolerability, though relapse rates remain high. This study evaluates the safety, efficacy, and tolerability of a novel RMT-EA regimen-rituximab, methotrexate, and thiotepa (RMT) induction followed by etoposide and cytarabine (EA) consolidation-in newly diagnosed, untreated PCNSL patients. The aim is to improve remission depth and prolong disease-free survival, especially in younger patients.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 41 (estimated)
- First submitted
- 9 Apr 2025
- Start date
- 2 Dec 2022
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- FengYan Jin
- Diseases
- Childhood cancers
- NCT number
- NCT06946407
What you commit to
- Study type: Interventional
- Planned participants: 41
- From 2 Dec 2022 to the primary completion date, 1 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known allergy to any of the investigational drugs or their excipients
Other illness
- Presence of another active malignancy
- Known history of HIV infection or diagnosis of acquired immunodeficiency syndrome (AIDS)
- Any condition that, in the opinion of the investigator, may lead to early study termination, including but not limited to:
Lab values
- Significant laboratory abnormalities
Other
- Severe comorbidities
- Serious social or family circumstances affecting safety or compliance
Who the study is looking for
- 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
Age in the registry: - to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Facility Name: The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.