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Clinical Trials in China / NCT06946407
Recruiting Not applicable

Rituximab, Methotrexate, and Tepadina Induction Followed by Etoposide and Cytarabine Consolidation in Primary Central Nervous System Lymphoma

NCT06946407 · tracked via the Priya Life Science China tracker
Sponsor
FengYan Jin
Phase
Not applicable
Started
2022-12-02
Last updated
2025-04-27

Condition(s) studied

Primary Central Nervous System Lymphoma (PCNSL)CNS Lymphoma Treatment

Investigational drug(s) / intervention(s)

Rituximab, Methotrexate, and Thiotepa (R-MT) Induction Followed by Etoposide and Cytarabine (EA) Consolidation

Rituximab, Methotrexate, and Thiotepa (R-MT) Induction Followed by Etoposide and Cytarabine (EA) Consolidation: Pre-induction Therapy (R-M regimen): Cycle 1-2 (C1-C2): Rituximab (R): 375 mg/m² IV, on Day 1 Methotrexate (MTX): 3.5 g/m² IV over 3 hours, on Day 2 Induction Therapy (R-MT regimen): Cycle 3-6 (C3-C6): Rituximab (R): 375 mg/m² IV, on Day 1 Methotrexate (MTX): 3.5 g/m² IV over 3 hours, on Day 2 Thiotepa (T): 30 mg/m² IV over 30 minutes, on Day 3 Consolidation Therapy (EA regimen): Cycle 7-8 (C7-C8): Etoposide (E): 5 mg/kg IV, every 12 hours on Days 1 and 2 Cytarabine (A): 2.0 g/m² IV over 2 hours, every 12 hours on Days 3 and 4

Study summary

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.

Eligibility

Sex
ALL
Min age
—
Max age
60 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Objective Response Rate (ORR) — From the date of enrollment until the end of induction and consolidation treatment, assessed up to approximately 8 months.
    Objective Response Rate (ORR): Defined as the proportion of participants who achieve Complete Remission (CR), Unconfirmed Complete Remission (CRu), or Partial Remission (PR) according to the International Primary CNS Lymphoma Collaborative Group (IPCG) efficacy assessment criteria.

Trial sites (1)

FacilityCityRegionStatus
Facility Name: The First Hospital of Jilin University Changchun China Recruiting

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Metabolic and Immunomic Differential Analysis of Primary Central Nervous System Diffuse Large B-Cell Lymphoma Recruiting
Pomalidomide, Anti-PD-1 Antibody Combined With Selinexor (PPS) in Relapsed/Refractory Primary Central Nervous System Diffuse Large B-Cell Lymphoma Recruiting
Zanubrutinib Plus Lenalidomide for Frail Elderly Patients With Newly Diagnosed PCNSL Recruiting
PD-1 Inhibitor Combined With Rituximab, Methotrexate, and Orelabrutinib (PD-1i+RMO) for Newly Diagnosed PCNSL and SCNSL. Recruiting
Registry of an Integrated Longitudinal Multimodal Biospecimen Biobank for Primary CNS Lymphoma in China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06946407 on ClinicalTrials.gov ↗ ← All trials in China