RecruitingNot ApplicableNCT06832267

Rituximab-Methotrexate-Temozolomide-Thiotepa (RMTT) Regimen As First-line Therapy for PCNS DLBCL

A Single-center, Single-arm Phase II Trial of Rituximab-Methotrexate-Temozolomide-Thiotepa (RMTT) Regimen As First-line Therapy for Primary Central Nervous System Diffuse Large B-cell Lymphomas(PCNS DLBCL)

Sponsor

Zhejiang Cancer Hospital

Enrollment

44 participants

Start Date

Feb 14, 2025

Study Type

INTERVENTIONAL

Conditions

Primary Central Nervous System Lymphoma

Summary

This study aims to observe and explore the efficacy and safety of Rituximab-Methotrexate-Temozolomide-Thiotepa (RMTT) regimen as first-line therapy for primary central nervous system diffuse large B-cell lymphomas(PCNS DLBCL)

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a four-drug chemotherapy regimen (rituximab, methotrexate, temozolomide, and thiotepa — called RMTT) as a first-line treatment for primary central nervous system diffuse large B-cell lymphoma (PCNS DLBCL), a rare cancer that originates in and stays within the brain or spinal cord. **You may be eligible if...** - You are between 18 and 75 years old - You have been newly diagnosed with PCNS DLBCL confirmed by pathology - You have measurable tumor in the brain (at least 1.5 cm in length) - You have not received any prior treatment for this condition (hormones to control symptoms are acceptable) - Your expected survival is at least 3 months - You agree to use contraception during and for six months after the study **You may NOT be eligible if...** - You have previously received any systemic therapy for this lymphoma - Your overall health status (ECOG score) is above 3 - Your organ function does not meet requirements 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-Temozolomide-Thiotepa (RMTT)

Rituximab: 375 mg/m2 intravenously on day 3,7; Methotrexate: 1.5-3.5 g/m2 intravenously on day 1,14(≤65 ,3.5g/m2；\>65,1.5g/m2); Temozolomide 150 mg/m2 on days 3-7； Thiotepa:40 mg/m2 intravenously on day 17。 Treatment will be given for 4 cycles（28 days for each cycle）, and patients who achieve a CR or better can choose to undergo ASCT or WBRT(23.4Gy).