RecruitingNot ApplicableNCT06946407

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

Sponsor

FengYan Jin

Enrollment

41 participants

Start Date

Dec 2, 2022

Study Type

INTERVENTIONAL

Conditions

Primary Central Nervous System Lymphoma (PCNSL)CNS Lymphoma Treatment

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

Max Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a specific chemotherapy combination for primary central nervous system lymphoma (PCNSL), a rare cancer that grows in the brain or spinal cord. The regimen uses rituximab, methotrexate, and thiotepa for induction, followed by etoposide and cytarabine for consolidation. **You may be eligible if...** - You are 60 years old or younger - You have been diagnosed with diffuse large B-cell lymphoma (DLBCL) confirmed as primary to the central nervous system (brain/spinal cord) - You have not received any prior treatment for this lymphoma - There is no evidence the lymphoma has spread outside the brain/spinal cord - You are able to provide written consent **You may NOT be eligible if...** - You have another active cancer - Your lymphoma has spread beyond the central nervous system - You have received prior treatment for this lymphoma - You are older than 60 - You have organ function that would make the chemotherapy unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRituximab, 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

Locations(1)

Facility Name: The First Hospital of Jilin University

Changchun, China

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