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ctDNA-guided Therapy Optimization in Newly Diagnosed DLBCL

NCT06693830 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-23

No results posted yet for this study

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).

Conditions

Interventions

DEVICE

Phased 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.

OTHER

Standard of Care Treatment

Standard of Care Treatment for cycles 1-6

OTHER

De-escalated Treatment

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Conquer Cancer Foundation

    collaborator OTHER

  • Foresight Diagnostics

    collaborator UNKNOWN

  • Hua-Jay J Cherng, MD

    lead OTHER

Principal Investigators

  • Hua-Jay J Cherng, MD · Columbia University

Study Design

Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-11
Primary Completion
2027-12-31
Completion
2029-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06693830 on ClinicalTrials.gov