ctDNA-guided Therapy Optimization in Newly Diagnosed DLBCL

Part of paid clinical trials in New York, New York.

Sponsor
Hua-Jay J Cherng, MD
Study ID
NCT06693830
Status
Recruiting
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Conditions

  • Diffuse Large B Cell Lymphoma
  • Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
  • High-grade B-cell Lymphoma
  • Lymphoma
  • Lymphoma, B-Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Phased Variant Enrichment and Detection Sequencing (PhasED-seq) — DEVICE
    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.
  • Standard of Care Treatment — OTHER
    Standard of Care Treatment for cycles 1-6
  • De-escalated Treatment — OTHER
    Standard of Care Treatment for cycles 1-4 and de-escalated treatment for cycles 5 and 6

Study Details

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).

Key Dates

Start date
Dec 11, 2024
Status verified
Jan 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Other: Group 1
    All participants on this study will receive standard immunochemotherapy treatment for the first 4 cycles. Blood samples will be collected for real-time ctDNA sequencing with the PhasED-seq assay. Participants with undetectable ctDNA from the first day of cycle 4 and in a complete response (CR) on their PET/CT scan will get de-escalated treatment for cycle 5 and cycle 6 (rituximab alone without chemotherapy)
  • Other: Group 2
    All participants on this study will receive standard immunochemotherapy treatment for the first 4 cycles. Blood samples will be collected for real-time ctDNA sequencing with the PhasED-seq assay. Participants with detectable ctDNA, not in in a CR on PET/CT, and/or whose ctDNA sequencing was unsuccessful for any reason will continue standard of care for the remainder of treatment (cycle 5 and 6).

Primary Outcome Measure

Success Rate of Real-Time Circulating Tumor DNA (ctDNA) Sequencing [ Time Frame: up to 5 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia UniversityNew YorkNew York10032
Research Nurse Navigator
[email protected]
212-305-0591
Hua-Jay J Cherng, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Columbia University· New York, NY

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