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ctDNA-guided Therapy for Newly Diagnosed DLBCL

This study is for people newly diagnosed with a type of lymphoma called Diffuse Large B-Cell Lymphoma (DLBCL). Researchers want to see if they can use a special blood test called PhasED-seq to measure circulating tumor DNA (ctDNA) in real-time during standard treatment. ctDNA is genetic material from cancer cells found in the blood. If your ctDNA levels are undetectable midway through treatment and your scans look good, you might receive a shorter course of chemotherapy. The goal is to see if this approach is possible and if it leads to good outcomes for patients. The study will enroll about 32 participants and does not involve new experimental drugs, but rather uses the PhasED-seq test to guide treatment decisions.

Study design
This interventional study plans to enroll 40 patients with newly diagnosed DLBCL, with a target of 32 participants. It is not specified if it is randomized or blinded.
What's involved
Participants will receive 4 cycles of R-CHOP or R-pola-CHP chemotherapy. Blood samples will be collected after 3 cycles, and interim scans will be performed. Some participants may then have their chemotherapy de-escalated for the final 2 cycles.
Compensation
Not stated in the trial record.
Follow-up
The study measures complete response rate (CRR) up to 6 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06693830

ctDNA-guided Therapy Optimization in Newly Diagnosed DLBCL

Recruiting
NAAges 18+InterventionalDevice feasibility
Hua-Jay J Cherng, MD
~40 participants
Updated 2026-01-23 on ClinicalTrials.gov
What's tested:Phased Variant Enrichment and Detection Sequencing (PhasED-seq)Standard of Care TreatmentDe-escalated Treatment

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Success Rate of Real-Time Circulating Tumor DNA (ctDNA) Sequencing
Measured over up to 5 months
+1 more outcome measured

Conditions

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

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Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Columbia University

    New York, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Hua-Jay J Cherng, MD · PRINCIPAL_INVESTIGATOR · Columbia University

Who to contact

Research Nurse Navigator
[email protected]
212-342-5162
Email the study team

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Eligibility criteria

Inclusion

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 ≥ 1.5 cm in longest diameter and measurable in two perpendicular dimensions, with at least one corresponding hypermetabolic lesion by Lugano classification on baseline FDG PET/CT or CT with intravenous contrast of the chest, abdomen, and pelvis if FDG PET/CT not available. 2. Age 18 years or older at time of screening 3. Subject/legal representative willing and able to provide written informed consent 4. Ability to comply with outpatient treatment, laboratory monitoring, and required clinic visits for duration of study participation 5. Organ function as assessed by laboratory and cardiac function testing and Eastern Cooperative Oncology Group (ECOG) performance status in appropriate range for receipt of R-CHOP or R-pola-CHP at standard dose as per treating physician

Exclusion

Up to 14 days of corticosteroids for the relief of lymphoma-related symptoms
A dose of pre-phase vincristine or rituximab
One cycle of R-chemotherapy (including but not limited to R-CHOP, R-pola-CHP, dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, rituximab \[DA-EPOCH-R) that has not started more than 28 days prior to consent
Intrathecal chemotherapy for central nervous system (CNS) prophylaxis
Radiation therapy for the treatment or prevention of spinal cord compression that has not started more than 28 days prior to enrollment 2. Simultaneous participation in other treatment clinical protocol 3. Planned anti-lymphoma therapies beyond R-CHOP or R-pola-CHP:
Consolidative radiation to any baseline sites of disease
Planned high-dose intravenous methotrexate for central nervous system (CNS) lymphoma prophylaxis (both mid-cycle and EOT excluded)
Any number of doses of intrathecal chemotherapy for CNS lymphoma prophylaxis are allowed 4. Transformed indolent lymphoma (including follicular lymphoma, marginal zone lymphoma, or lymphoplasmacytic lymphoma) or grade IIIB follicular lymphoma 5. Known CNS involvement by lymphoma. R-CHOP and R-pola- CHP are insufficient to treat CNS disease. 6. Any disease characteristics that would make R-CHOP or R-pola-CHP without radiation insufficient therapy at the discretion of the treating physician
High-grade B-cell lymphoma with rearrangement of MYC and BCL2, primary mediastinal B-cell lymphoma, and HIV-associated lymphomas are excluded 7. Richter transformation of chronic lymphocytic leukemia 8. Pregnancy and/or nursing period. R-CHOP and R-pola-CHP may cause fetal harm or birth defects, and effects of exposure in the breastfed infant are unknown.
A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "childbearing potential"
Women of childbearing potential are eligible if a negative serum or urine beta human chorionic gonadotropin pregnancy test is documented within 28 days of screening, and they must agree to us an effective contraception method during systemic treatment
Men who have partners of childbearing potential must agree to use an effective contraceptive method during systemic treatment
In addition to routine contraceptive methods, "acceptable contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen. 9. Uncontrolled active systemic infection
Patients with a positive hepatitis B virus (HBV) core antibody and negative HBV surface antigen consistent with prior HBV exposure must be willing to take appropriate anti-viral prophylaxis.
Patients with evidence of chronic HBV infection must have undetectable HBV viral load on the most recent test results obtained within the last year and received suppressive therapy.
Participants with a history of hepatitis C virus (HCV) infection must have an undetectable viral load. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 28 days prior to consent. 10. Active second malignancy unless in remission and with life expectancy \> 2 years with exception of patients diagnosed with basal cell or squamous cell carcinoma of the skin or carcinoma "in situ" of the cervix or breast who are eligible even if diagnosed within 2 years. If patients have another malignancy that was treated within the last 2 years, such patients may be enrolled, if the likelihood of requiring systemic therapy for this other malignancy within 2 years is less than 10%, as determined by an expert in that particular malignancy at CUIMC, and after consultation with the Principal Investigator. Hormone therapy for treated prostate and breast cancer is allowed. 11. Known hypersensitivity to any component of R-CHOP or R-pola-CHP

What this trial measures

  • Success Rate of Real-Time Circulating Tumor DNA (ctDNA) Sequencingup to 5 months

    Success defined as: C4D1 sample collected, DNA successfully sequenced from the diagnostic tissue sample, C4D1 timepoint result must be available within 28 days of C4D1

  • Complete Response Rate (CRR)up to 6 months

    Complete response rate as assessed by PET/CT scan in participants who receive de-escalated treatment