Age-adjusted High-dose Chemotherapy Followed by Autologous Stem Cell Transplantation or Conventional Chemotherapy With R-MP as First-line Treatment in Elderly Primary CNS Lymphoma Patients - a Randomized Phase III Trial

What this Trial Is About

Primary diffuse large B-cell lymphoma of the central nervous system (PCNSL) mainly affects patients aged 60 and above, who often face a poor outlook. This trial compares two treatment options for elderly patients 65 years and older with newly diagnosed PCNSL who are eligible for high-dose methotrexate (HD-MTX) therapy. The study aims to determine which treatment approach improves survival, response rates, quality of life, and reduces treatment-related side effects in this vulnerable group. One treatment uses the R-MP regimen, which includes rituximab, HD-MTX, and procarbazine given in cycles followed by maintenance procarbazine therapy. The other approach involves a shorter induction treatment with rituximab, HD-MTX, and cytarabine, followed by age-adjusted high-dose chemotherapy and autologous stem cell transplantation (HCT-ASCT). Patients receive either three cycles of R-MP plus procarbazine maintenance or two cycles of R-MTX/AraC followed by the stem cell transplant procedure with additional chemotherapy drugs. Participants will undergo regular assessments including remission status evaluations after early and later treatment phases, quality of life questionnaires, and long-term monitoring for up to six years. The primary outcome is progression-free survival, with secondary outcomes including overall survival, event-free survival, and quality of life measures. Researchers will also perform geriatric assessments to help define eligibility for the transplant procedure and monitor treatment safety and effectiveness throughout the study period.

Adjusted High-dose Chemotherapy With Autologous Stem Cell Transplant vs. Conventional Immunochemotherapy in Elderly PCNSL Patients