ctDNA-guided Therapy Optimization in Newly Diagnosed DLBCL
United States40 participantsStarted 2024-12-11
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients with newly diagnosed, histologically confirmed CD20+ DLBCL
✓. Age 18 years or older at time of screening
✓. Subject/legal representative willing and able to provide written informed consent
✓. Ability to comply with outpatient treatment, laboratory monitoring, and required clinic visits for duration of study participation
✓. Organ function as assessed by laboratory and cardiac function testing and Eastern Cooperative Oncology Group (ECOG) performance status in appropriate range for receipt of R-CHOP or R-pola-CHP at standard dose as per treating physician
Exclusion criteria
✕. Previous treatment for diffuse large B-cell lymphoma, except as outlined below:
✕. Simultaneous participation in other treatment clinical protocol
✕. Planned anti-lymphoma therapies beyond R-CHOP or R-pola-CHP:
✕. Transformed indolent lymphoma (including follicular lymphoma, marginal zone lymphoma, or lymphoplasmacytic lymphoma) or grade IIIB follicular lymphoma
What they're measuring
1
Success Rate of Real-Time Circulating Tumor DNA (ctDNA) Sequencing
✕. Known CNS involvement by lymphoma. R-CHOP and R-pola- CHP are insufficient to treat CNS disease.
✕. Any disease characteristics that would make R-CHOP or R-pola-CHP without radiation insufficient therapy at the discretion of the treating physician
✕. Richter transformation of chronic lymphocytic leukemia
✕. Pregnancy and/or nursing period. R-CHOP and R-pola-CHP may cause fetal harm or birth defects, and effects of exposure in the breastfed infant are unknown.