Using RMTT regimen as first-line therapy for primary central nervous system lymphoma

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)

This study is testing if a new combination treatment called RMTT can help people with primary central nervous system lymphoma who haven't had treatment before.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Zhejiang Cancer Hospital (Academic / other)
• Drugs / interventions: Rituximab, Methotrexate
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06832267 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the efficacy and safety of the Rituximab-Methotrexate-Temozolomide-Thiotepa (RMTT) regimen as a first-line treatment for patients diagnosed with primary central nervous system diffuse large B-cell lymphoma (PCNS DLBCL). Participants will be closely monitored for their response to the treatment and any potential side effects. The study focuses on patients who have not previously received systemic therapy for their condition. The goal is to determine if this combination therapy can improve outcomes for these patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with newly diagnosed PCNS DLBCL and specific tumor characteristics.

Not a fit: Patients who have received prior systemic therapy or have a poor prognosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective first-line therapy option for patients with PCNS DLBCL.

How similar studies have performed: While there is ongoing research in this area, the specific combination of RMTT as a first-line therapy is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* Patients voluntarily joined the study, signed the informed consent, and had good compliance;
* Patients with 18 Years to 75 Years(at the time of signing the informed consent); Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score: 0-3;
* Patients with histopathologically confirmed newly diagnosed primary central nervous system diffuse large B-cell lymphoma, and there were intracranial evaluable lesions (long diameter greater than 1.5cm, short diameter greater than 1cm);
* Patients who have not received any systemic therapy, except those who use hormones to control complications
* Expected survival of more than 3 months.
* Female patients of reproductive age should agree that birth control (such as intrauterine device, birth control pills, or condoms) must be used during the study period and for six months after completion; Having a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating; Male patients should agree to use contraception during the study period and for six months after the end of the study.

Exclusion Criteria:

* Patients who have previously received antitumor therapy or targeted therapy
* Patients who have undergone major surgery within the past 3 weeks .
* Presence of severe or uncontrolled comorbid conditions including, but not limited to, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, active peptic ulcer disease, or severe hemorrhagic disorders such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring transfusion or other medical interventions.
* Any active infection requiring systemic antimicrobial therapy within 14 days before starting study treatment, including, but not limited to, bacterial, fungal, and viral infections.
* Patients who are pregnant or breastfeeding.
* Current participation in other clinical studies, or initiation of study drugs administration less than 4 weeks after completion of previous clinical study treatment.
* Patients with concomitant diseases that, in the investigator's judgment, may seriously endanger patients' safety or may interfere with the completion of the study, or are deemed unsuitable for inclusion for other reasons.

Where this trial is running

Hangzhou, Zhejiang

• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Haiyan Yang — Zhejiang Cancer Hospital
• Study coordinator: Haiyan Yang, PhD

Conditions Primary Central Nervous System Lymphoma