Phase II Trial of Glofitamab and Polatuzumab Vedotin-Based Therapy Using PET and ctDNA to Tailor Treatment for Untreated Diffuse Large B Cell Lymphoma

What this Trial Is About

Researchers are evaluating a new treatment approach for adults with untreated diffuse large B cell lymphoma DLBCL in this phase II, multicenter study. The study focuses on using a response-adapted strategy based on interim blood tests measuring circulating tumor DNA ctDNA and scans using FDG-PET to optimize therapy. This approach aims to better tailor treatment according to individual risk and tumor response early in the treatment process. Participants will receive six cycles of therapy, each lasting 21 days. The first two cycles include a combination of polatuzumab vedotin, cyclophosphamide, doxorubicin, prednisone, and rituximab Pola-R-CHP. After these initial cycles, patients are assessed with ctDNA testing and PET scans. Those with favorable risk continue with two more cycles of Pola-R-CHP followed by two cycles of rituximab alone. Patients at higher risk receive four additional cycles of Pola-R-CHP combined with the drug glofitamab. Treatment doses and schedules are carefully monitored and adjusted based on these risk assessments. Throughout the study, participants undergo regular evaluations including blood tests for ctDNA, PETCT scans, CT scans, and bone marrow biopsies as needed. After completing treatment, patients enter a follow-up phase with visits every three months for lab tests and ctDNA monitoring, and imaging every six months. The main outcome measured is the feasibility of adapting therapy based on interim ctDNA and PET results. Secondary outcomes include survival, treatment side effects, and quality of life over a two-year period. The total involvement in the study spans approximately two years from treatment start through follow-up.

Feasibility Trial of Glofitamab in a Response Adapted Approach Incorporating Interim FDG PET and ctDNA to Optimize Primary Therapy of DLBCL (GRAIL)