Study of Circulating Tumor DNA for Early Treatment Response in Primary Central Nervous System Lymphoma Patients Receiving First-Line Curative Therapy Including MATRix and High-Dose Chemotherapy with Stem Cell Transplantation

What this Trial Is About

Researchers are evaluating circulating tumor DNA ctDNA to assess early treatment response in patients with primary central nervous system lymphoma PCNSL receiving standard first-line therapy aimed at cure. This international, prospective, multicenter observational study also examines clinical features, health-related quality of life, neurological status, and outcomes of newly diagnosed PCNSL patients in Nordic countries. The goal includes identifying new prognostic and predictive biomarkers through molecular analyses of tumor tissue, cerebrospinal fluid, and plasma samples. Participants receive standard of care first-line therapies with curative intent, such as MATRix chemotherapy combined with high-dose chemotherapy and autologous stem cell transplantation. Throughout treatment, diagnostic tumor tissue, cerebrospinal fluid, and blood plasma are collected for ctDNA and other translational analyses. Treatment responses are evaluated using the International PCNSL Collaborative Group IPCG criteria, with MRI scans centrally reviewed to identify new markers. Participants are involved in regular assessments including MRI imaging for diagnostic and response evaluation, collection of biological samples, and monitoring of neurological status and quality of life. The primary outcome measure is ctDNA analysis six months after starting first-line therapy. The study includes follow-up to monitor outcomes and safety, with participant involvement lasting throughout their course of standard treatment and assessments.

CtDNA for Early Response Assessment in PCNSL Treated with 1st Line Curative Intent (NLG-PCNSL-01)