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Blood test may let some lymphoma patients skip late chemo rounds

NCT ID NCT06693830

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether a new blood test (PhasED-seq) can detect leftover cancer DNA in real time during standard chemotherapy for newly diagnosed diffuse large B-cell lymphoma (DLBCL). For patients whose blood shows no cancer DNA halfway through treatment, doctors will shorten the remaining chemo from 6 to 4 cycles. The goal is to see if this approach is feasible and safe, potentially sparing patients from extra side effects. The trial enrolls 40 adults with stage II–IV DLBCL and uses no experimental drugs—only the test itself is investigational.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PhasED-seq blood test (ctDNA monitoring)
What this could lead to
If successful, this approach could allow some DLBCL patients to receive less chemotherapy, reducing side effects without compromising cancer control.
What could go wrong
This is a small, early feasibility study (40 participants) using an unapproved test. It is not designed to prove long-term outcomes, and the shortened chemo may not work as well as standard treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients with newly diagnosed, histologically confirmed CD20+ DLBCL * 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 Criteria: 1. Previous treatment for diffuse large B-cell lymphoma, except as outlined below: * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Columbia University

    RECRUITING

    New York, New York, 10032, United States

    Contact Email: •••••@•••••

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