The purpose of this study is to 1) determine whether it is feasible to measure circulating tumor DNA (ctDNA) in real-time during standard treatment for newly diagnosed diffuse large B-cell lymphoma (DLBCL), and 2) evaluate the outcomes of participants with undetectable ctDNA in the middle of treatment who receive a shortened course of chemotherapy.
There are no investigational drug agents to be administered in this study. The investigational assay, phased variant enrichment and detection sequencing (PhasED-seq) will be used to guide de-escalation of standard-of-care therapy for newly diagnosed DLBCL.
The PhasED-seq assay has not yet been approved by the Food and Drug Administration (FDA).
Patients with newly diagnosed, histologically confirmed CD20+ DLBCL
Stage II-IV disease
Planned for anthracycline-based therapy with standard dosed R-CHOP or R-pola- CHP without consolidative radiation
Measurable disease on cross sectional imaging ≥ 1.5 cm in longest diameter and measurable in two perpendicular dimensions, with at least one corresponding hypermetabolic lesion by Lugano classification on baseline FDG PET/CT or CT with intravenous contrast of the chest, abdomen, and pelvis if FDG PET/CT not available.
Up to 14 days of corticosteroids for the relief of lymphoma-related symptoms
A dose of pre-phase vincristine or rituximab
One cycle of R-chemotherapy (including but not limited to R-CHOP, R-pola-CHP, dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, rituximab [DA-EPOCH-R) that has not started more than 28 days prior to consent
Intrathecal chemotherapy for central nervous system (CNS) prophylaxis
Hua-Jay J Cherng, MD
Lead sponsor
Columbia University
Sponsor institution
National Cancer Institute (NCI)
Collaborator
Conquer Cancer Foundation
Collaborator
Foresight Diagnostics
Collaborator