Actively Recruiting

Phase Not Applicable
Age: 0 - 60Years
All Genders
NCT06946407

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

Led by FengYan Jin · Updated on 2025-04-27

41

Participants Needed

1

Research Sites

365 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 0 - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 60 years or younger, male or female
  • Confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) without previous treatment
  • No signs of lymphoma outside the brain based on physical exams and lab or imaging tests
  • Diagnosis meets criteria for primary central nervous system lymphoma (PCNSL)
  • Written informed consent provided by patient or legal guardian
  • Voluntary agreement to join the study
Not Eligible

You will not qualify if you...

  • Presence of another active cancer
  • Known HIV infection or diagnosis of AIDS
  • Allergy to any study drugs or their ingredients
  • Any condition that might cause early study stopping, such as severe other illnesses, serious lab abnormalities, or social/family issues affecting safety or compliance

AI-Screening

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Trial Site Locations

Total: 1 location

1

Facility Name: The First Hospital of Jilin University

Changchun, China

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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