On December 5, 2024 Foresight Diagnostics, a leader in ultra-sensitive minimal residual disease (MRD) detection technology, reported the launch of SHORTEN-ctDNA, a clinical trial at Columbia University (Press release, Foresight Diagnostics, DEC 5, 2024, View Source [SID1234648847]). The study aims to evaluate the ability to utilize Foresight CLARITY MRD detection to enable real-time treatment optimization for patients with diffuse large B-cell lymphoma (DLBCL).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Currently the standard treatment for newly diagnosed DLBCL requires six cycles of combination rituximab and chemotherapy regardless of individual patient response. This one-size-fits-all approach leaves little room for personalization, potentially exposing patients to unnecessary treatment. The SHORTEN-ctDNA trial will investigate whether patients who achieve early clearance of circulating tumor DNA (ctDNA) can safely receive fewer cycles of chemotherapy while maintaining long-term survival outcomes.
"Although PET scans remain our standard tool for monitoring lymphoma treatment, their inconsistent results in identifying active disease limit our ability to make real-time treatment decisions," said David Kurtz, MD, PhD, Chief Medical Officer and Head of Research at Foresight Diagnostics. "Foresight CLARITY’s detection of residual disease could be the game-changer we need, potentially allowing us to confidently adjust therapy based on each patient’s actual response to treatment with a more dynamic and sensitive tool than imaging."
The study will enroll approximately 32 newly diagnosed DLBCL patients. After three cycles of R-CHOP or pola-R-CHP therapy, participants will undergo ctDNA testing. Those with detectable disease (MRD-positive) will continue with rituximab plus chemotherapy for their remaining cycles, while patients who achieve undetectable ctDNA levels (MRD-negative) will de-escalate to rituximab alone for their final two cycles.
"Recent evidence suggests many patients achieve very deep remissions earlier in their R-chemo treatment than previously thought," said Hua-Jay Cherng, MD, assistant professor of medicine at Columbia University Vagelos College of Physicians and Surgeons and Principal Investigator of the study. "By using next-generation, ultra-sensitive ctDNA technology, SHORTEN-ctDNA aims to identify these early responders and personalize their treatment strategy, potentially reducing treatment duration and associated toxicity and hopefully getting patients back to their normal lives sooner."