Actively Recruiting
ctDNA-guided Therapy Optimization in Newly Diagnosed DLBCL
Led by Hua-Jay J Cherng, MD · Updated on 2026-01-23
40
Participants Needed
1
Research Sites
259 weeks
Total Duration
On this page
Sponsors
H
Hua-Jay J Cherng, MD
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
ctDNA-guided Therapy Optimization in Newly Diagnosed DLBCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed patients with histologically confirmed CD20+ diffuse large B-cell lymphoma
- Stage II-IV disease
- Planned for anthracycline-based therapy with standard R-CHOP or R-pola-CHP without radiation
- Measurable disease on imaging at least 1.5 cm in longest diameter and measurable in two perpendicular dimensions
- Age 18 years or older at screening
- Willing and able to provide informed consent
- Able to comply with outpatient treatment, lab monitoring, and clinic visits throughout the study
- Adequate organ and cardiac function and suitable ECOG performance status for R-CHOP or R-pola-CHP standard dosing
You will not qualify if you...
- Previous treatment for diffuse large B-cell lymphoma except up to 14 days of corticosteroids, a dose of pre-phase vincristine or rituximab, one cycle of R-chemotherapy started less than 28 days before consent, intrathecal chemotherapy for CNS prophylaxis, or radiation for spinal cord compression started less than 28 days before enrollment
- Participation in other treatment clinical trials
- Planned lymphoma treatments beyond R-CHOP or R-pola-CHP including consolidative radiation or high-dose methotrexate for CNS prophylaxis
- Transformed indolent lymphoma or grade IIIB follicular lymphoma
- Known CNS involvement by lymphoma
- Disease characteristics requiring therapies beyond R-CHOP or R-pola-CHP without radiation as judged by the physician
- Richter transformation of chronic lymphocytic leukemia
- Pregnancy or nursing; women of childbearing potential must have a negative pregnancy test and agree to contraception
- Men with partners of childbearing potential must agree to use effective contraception
- Uncontrolled active systemic infection including hepatitis B or C without appropriate viral suppression
- Active second malignancy unless in remission with life expectancy over 2 years, except some skin or in situ cancers
- Known hypersensitivity to any component of R-CHOP or R-pola-CHP
AI-Screening
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Trial Site Locations
Total: 1 location
1
Columbia University
New York, New York, United States, 10032
Actively Recruiting
Research Team
R
Research Nurse Navigator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
2
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