Actively Recruiting
Sequencing-guided Chemotherapy Optimization Using Real-Time Evaluation in Newly Diagnosed Diffuse Large B-Cell Lymphoma with Circulating Tumor DNA
Led by Hua-Jay J Cherng, MD · Updated on 2026-01-23
40
Participants Needed
1
Research Sites
104 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
Researchers are evaluating whether it is possible to measure circulating tumor DNA (ctDNA) in real-time during standard treatment for newly diagnosed diffuse large B-cell lymphoma (DLBCL). The study also aims to assess outcomes for participants who have undetectable ctDNA mid-treatment and receive a shortened chemotherapy course. The investigational assay PhasED-seq will guide treatment de-escalation, although it has not yet been approved by the FDA. Participants will receive standard immunochemotherapy for the first 4 cycles using either R-CHOP or R-pola-CHP. Blood samples will be collected after 3 cycles to measure ctDNA using the PhasED-seq assay. Those with undetectable ctDNA and complete remission on interim scans will have their treatment de-escalated, receiving rituximab alone for cycles 5 and 6. Others will continue with the full standard treatment. During the study, participants will have blood drawn for ctDNA testing and undergo PET/CT scans for response assessment. Researchers will monitor the success rate of real-time ctDNA sequencing and the complete response rate within 5 to 6 months. Secondary outcomes include minimal residual disease negativity, time to ctDNA result, eligibility for treatment de-escalation, progression-free survival, and overall survival over two years. The study involves outpatient treatment, lab monitoring, and clinic visits up to 6 cycles of therapy.
CONDITIONS
Brief Title
ctDNA-guided Therapy Optimization in Newly Diagnosed DLBCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with newly diagnosed, histologically confirmed CD20+ diffuse large B-cell lymphoma (DLBCL) with stage II-IV disease
- Planned for anthracycline-based therapy with standard dosed R-CHOP or R-pola-CHP without consolidative radiation
- Measurable disease on cross-sectional imaging at least 1.5 cm in longest diameter and measurable in two perpendicular dimensions
- Age 18 years or older at time of screening
- Ability to provide written informed consent
- Ability to comply with outpatient treatment, laboratory monitoring, and clinic visits during study
- Organ function and performance status suitable for standard R-CHOP or R-pola-CHP as assessed by treating physician
You will not qualify if you...
- Previous treatment for DLBCL except up to 14 days of corticosteroids, one cycle of R-chemotherapy within 28 days prior to consent, intrathecal chemotherapy, or radiation started within 28 days prior to enrollment
- Participation in other treatment clinical protocols
- Planned additional anti-lymphoma therapies 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 making R-CHOP or R-pola-CHP insufficient therapy as determined by physician
- Richter transformation of chronic lymphocytic leukemia
- Pregnancy or nursing; women of childbearing potential must have negative pregnancy test and use effective contraception
- Uncontrolled active systemic infection
- Active second malignancy unless in remission with life expectancy over 2 years
- Known hypersensitivity to any component of R-CHOP or R-pola-CHP
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Approximately 18 weeks (6 cycles of treatment)
Participants receive standard immunochemotherapy treatment for the first 4 cycles with blood samples collected for real-time ctDNA sequencing. Based on ctDNA results and interim scans, some participants will de-escalate treatment and receive rituximab alone for the final 2 cycles, while others continue standard treatment for all 6 cycles.
6 treatment visits corresponding to each cycle
Duration - Up to 2 years
Participants are monitored for treatment response, progression-free survival, and overall survival after completing treatment.
Periodic follow-up visits over 2 years
Trial Site Locations
Total: 1 location
1
Columbia University
New York, New York, United States, 10032
Actively Recruiting
Research Team
R
Research Nurse Navigator
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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