NEW YORK – Foresight Diagnostics said Thursday that it launched a clinical trial to evaluate the use of its Clarity minimal residual disease (MRD) assay in guiding individual treatment decisions for people with diffuse large B-cell lymphoma (DLBCL).
The trial, called SHORTEN-ctDNA (Sequencing-guided cHemotherapy Optimization using Real-Time Evaluation in Newly Diagnosed DLBCL with circulating tumor DNA), is taking place at Columbia University and will investigate whether patients who achieve early ctDNA clearance can safely receive fewer cycles of chemotherapy while maintaining long-term survival outcomes.
The Clarity MRD assay incorporates Foresight's PhasED-Seq technology, which uses the improbability of two or more mutations occurring on the same ctDNA fragment as a way to boost sensitivity while reducing sequencing errors.
The study aims to recruit 32 patients with newly diagnosed DLBCL. They will receive either standard treatment with four cycles of the combination treatments R-CHOP or pola-R-CHP immunochemotherapy, and ctDNA will be measured in blood samples taken after three cycles. Participants with undetectable ctDNA and complete remission on interim restaging scans will have their treatments de-escalated and be taken off chemotherapy for their final two cycles of treatments. They will then receive rituximab alone for their final two cycles, while all other participants will remain on standard treatment.
"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," David Kurtz, chief medical officer at Foresight, said in a statement.
Foresight and the trial investigators hope that the use of Clarity MRD will identify early treatment responders, enabling physicians to better personalize treatment strategies, potentially reducing treatment duration and any associated toxicity.
Stanford University licensed the PhasED-Seq technology to Foresight. Stanford, Foresight, and company founders Maximilian Diehn and Arash Ash Alizadeh have all been named in a lawsuit brought by Roche, which accused them of having stolen trade secrets related to cancer detection and genetic sequencing technology.