Intermediate Dose of IV MTX as CNS Prophylaxis for High Risk DLBCL

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · Sep 21, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the use of an intermediate dose of intravenous methotrexate (IV MTX) to help prevent the central nervous system (CNS) from being affected in patients with high-risk diffuse large B-cell lymphoma (DLBCL). DLBCL is a type of cancer that can sometimes spread to the brain or spinal cord, which is a serious concern for patients with certain risk factors. Previous research suggests that a specific dose of IV MTX may lower the chances of CNS relapse significantly, and this trial aims to confirm those findings by comparing it to another treatment method.

To participate in this trial, individuals must be at least 18 years old and have high risk factors for CNS involvement, such as having cancer in more than one area outside of the lymph nodes. They should be starting their first line of treatment with a specific chemotherapy regimen called RCHOP and must not have any signs of CNS involvement when they join the study. Participants will receive the study treatment and will be monitored closely to see how well it works in preventing CNS relapse. If you or someone you know fits these criteria and is interested, this trial could offer an opportunity to be part of important research that may improve outcomes for high-risk DLBCL patients.

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Eligibility criteria

• Inclusion Criteria:
• • age ≥ 18 years
• • with high CNS risk, which was defined as involvement of more than one extranodal site, or involvement of particular extranodal sites such as bone marrow, breasts, testes, paranasal sinuses, epidural space, adrenal glands, kidney and female genital system;
• • first-line treatment planned to be RCHOP
• • absence of CNS involvement at presentation
• Exclusion Criteria:
• • primary CNS lymphoma
• • already have CNS involvement at diagnosis
• • primary mediastinal lymphoma, intravascular large B-cell lymphoma, DLBCL leg-type, Burkitt lymphoma, high-grade lymphomas, double expressor lymphoma
• • with active infection or other malignancy
• • severe liver or kidney insufficiency
• • allergy to any medication we plan to use