Using Real-Time ctDNA Testing to Adjust Chemotherapy in Newly Diagnosed Diffuse Large B-Cell Lymphoma

What this Trial Is About

Researchers are evaluating whether it is possible to measure circulating tumor DNA ctDNA in real-time during standard treatment for newly diagnosed diffuse large B-cell lymphoma DLBCL. The study also aims to assess outcomes for participants who have undetectable ctDNA mid-treatment and receive a shortened chemotherapy course. The investigational assay PhasED-seq will guide treatment de-escalation, although it has not yet been approved by the FDA. Participants will receive standard immunochemotherapy for the first 4 cycles using either R-CHOP or R-pola-CHP. Blood samples will be collected after 3 cycles to measure ctDNA using the PhasED-seq assay. Those with undetectable ctDNA and complete remission on interim scans will have their treatment de-escalated, receiving rituximab alone for cycles 5 and 6. Others will continue with the full standard treatment. During the study, participants will have blood drawn for ctDNA testing and undergo PETCT scans for response assessment. Researchers will monitor the success rate of real-time ctDNA sequencing and the complete response rate within 5 to 6 months. Secondary outcomes include minimal residual disease negativity, time to ctDNA result, eligibility for treatment de-escalation, progression-free survival, and overall survival over two years. The study involves outpatient treatment, lab monitoring, and clinic visits up to 6 cycles of therapy.

ctDNA-guided Therapy Optimization in Newly Diagnosed DLBCL