RecruitingNot ApplicableNCT06693830

ctDNA-guided Therapy Optimization in Newly Diagnosed DLBCL

Sequencing-guided cHemotherapy Optimization Using Real-Time Evaluation in Newly Diagnosed DLBCL With Circulating Tumor DNA: SHORTEN-ctDNA


Sponsor

Hua-Jay J Cherng, MD

Enrollment

40 participants

Start Date

Dec 11, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is using circulating tumor DNA (ctDNA) — tiny fragments of cancer DNA found in the blood — to guide treatment decisions in patients newly diagnosed with diffuse large B-cell lymphoma (DLBCL), the most common type of aggressive blood cancer. The goal is to optimize therapy based on how a patient's cancer is responding in real time. **You may be eligible if...** - You are 18 or older and have been newly diagnosed with DLBCL (a type of non-Hodgkin lymphoma) confirmed by biopsy - Your cancer is stage II, III, or IV - You are planned to receive standard immunochemotherapy (R-CHOP or a similar regimen) - You have at least one measurable tumor on imaging - Your heart and organ function is adequate to receive standard treatment **You may NOT be eligible if...** - You have been previously treated for DLBCL (with limited exceptions such as a short course of steroids or one cycle of chemotherapy) - You have transformed lymphoma (another lymphoma type that changed into DLBCL) - You have active central nervous system lymphoma - You have a serious coexisting illness that would interfere with treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPhased Variant Enrichment and Detection Sequencing (PhasED-seq)

PhasED-seq designed to detect minimal residual disease (MRD) as indicated by the presence of circulating tumor DNA (ctDNA) evidenced by an aggregate signal of phased variants (PVs) in the plasma of patients diagnosed with large B-cell lymphoma (LBCL) following first-line therapy.

OTHERStandard of Care Treatment

Standard of Care Treatment for cycles 1-6

OTHERDe-escalated Treatment

Standard of Care Treatment for cycles 1-4 and de-escalated treatment for cycles 5 and 6


Locations(1)

Columbia University

New York, New York, United States

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NCT06693830


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