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

Launched by ZHEJIANG CANCER HOSPITAL · Feb 12, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment plan called Rituximab-Methotrexate-Temozolomide-Thiotepa (RMTT) for patients with a type of brain cancer known as primary central nervous system diffuse large B-cell lymphoma (PCNS DLBCL). The goal is to see how effective and safe this treatment is when given as the first option for patients who have just been diagnosed. The trial is currently looking for participants, specifically adults between the ages of 18 and 75 who have not yet received any chemotherapy or similar treatments for their condition.

To be eligible for the trial, participants should have a confirmed diagnosis of PCNS DLBCL and certain measurable lesions in the brain. They should also be in generally good health, with a life expectancy of at least three months. Women of childbearing age need to use effective birth control during the study, and men must agree to do the same. Participants will have the chance to receive this promising treatment and will be closely monitored throughout the trial to ensure their safety. It's important to note that people with certain medical conditions or those who have recently undergone surgery or other treatments may not be eligible to join.

Gender

ALL

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.