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Rituximab, Methotrexate, and Tepadina Induction Followed by Etoposide and Cytarabine Consolidation in Primary Central Nervous System Lymphoma
NCT06946407 · The First Hospital of Jilin University
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
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
About this study
A retrospective analysis conducted at the study center demonstrated an objective response rate (ORR) of 64.3% among patients with primary central nervous system lymphoma (PCNSL) receiving chemotherapy. This prospective, single-arm clinical study is designed to evaluate the safety, efficacy, and tolerability of a novel treatment regimen-rituximab, methotrexate, and thiotepa (RMT) for induction, followed by etoposide and cytarabine (EA) for consolidation-in patients with newly diagnosed PCNSL.
The study hypothesizes that the RMT-EA regimen will increase the ORR to 84% while maintaining an acceptable safety profile. The goal is to generate additional evidence to support the optimization of frontline therapy for PCNSL, with a focus on improving remission depth, minimizing relapse rates, and extending progression-free survival, particularly in younger patient populations.
Eligibility 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
Study design
Enrollment target: 41 participants
Allocation: na
Masking: none
Age groups: child, adult
Timeline
Starts: 2022-12-02
Estimated completion: 2029-12-01
Last updated: 2025-04-27
Interventions
Drug: Rituximab, Methotrexate, and Thiotepa (R-MT) Induction Followed by Etoposide and Cytarabine (EA) Consolidation
Primary outcomes
- • Objective Response Rate (ORR) (From the date of enrollment until the end of induction and consolidation treatment, assessed up to approximately 8 months.)
Sponsor
FengYan Jin · other
All locations (1)
Facility Name: The First Hospital of Jilin UniversityRecruiting
Changchun, China