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A Study of Circulating Tumor DNA (ctDNA) Testing for B-Cell Lymphoma

This study is looking at a new test called Cerebral Spinal Fluid (CSF) circulating tumor DNA (ctDNA) for people with B-cell lymphoma who are at high risk for their cancer spreading to the brain or spinal cord (central nervous system/CNS relapse). The study wants to see how many people test positive for CSF ctDNA even when standard tests don't show CNS involvement. It also aims to understand how often CNS relapse happens in people with and without detectable CSF ctDNA. You might be able to join if you are 18 or older and have certain types of B-cell lymphoma. The study plans to enroll 50 participants.

Study design
This interventional study plans to enroll 50 participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure the incidence of positive CSF ctDNA for up to 2 years.

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

NCT06736613

A Study of Circulating Tumor DNA (ctDNA) Testing for People With B-Cell Lymphoma

Recruiting
PHASE2Ages 18+InterventionalDiagnostic
Memorial Sloan Kettering Cancer Center
~50 participants
Updated 2025-12-18 on ClinicalTrials.gov
What's tested:Cerebral Spinal Fluid ctDNA

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of positive cerebral spinal fluid/CSF ctDNA
Measured over up to 2 years

Conditions

Diffuse Large B Cell Lymphoma
High-grade B-cell Lymphoma
Stage III High Grade B-Cell Lymphoma
Stage IV High Grade B-Cell Lymphoma
DLBCL - Diffuse Large B Cell Lymphoma
Intravascular Large B-Cell Lymphoma
Diffuse Large B Cell Lymphoma of Breast
Diffuse Large B Cell Lymphoma of Testis
HIV-associated Diffuse Large B Cell Lymphoma
Double Expressor DLBCL

Explore related trials

Diffuse Large B-Cell LymphomaHigh Grade B-Cell LymphomaIntravascular Large B-Cell LymphomaPrimary Cutaneous DLBCL, Leg Type

NCT06736613

Where you'd take part

This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Cancer Center (All Protocol Activites)

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Rockville Centre, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

    Commack, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, 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

  • Jennifer Lue, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Jennifer Lue, MD
[email protected]
646-608-4160
Email the study team

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Eligibility criteria

Inclusion

Signed Informed Consent.
Ability and willingness to comply with the requirements of the study protocol.
Age ≥ 18 years old.
Diagnosis of the following histologies according to the 2016 WHO Classification for Mature Lymphoid Neoplasms81 along with a specific high-risk criteria for CNS relapse if indicated as certain diagnoses in of themselves are high-risk alone:
Transformed DLBCL from any indolent B-cell lymphoma is permitted (as long as there is no prior history of CNS involvement).
Planned to receive standard chemoimmunotherapy.
Patient is able to undergo lumbar puncture without any contraindications which include but are not limited to altered mental status, increased intracranial pressure due to any CNS lesion (mass, abscess), overlying skin infection at the site of LP, inability to safely access CSF due to lymphomatous involvement (i.e. epidural mass), or inability to hold antiplatelet or anticoagulation safely for the procedure to be performed.
No systemic therapy prior to study enrollment for an aggressive B-cell lymphoma is permitted. Treatment for a history of indolent lymphoma is permitted. Systemic corticosteroids are permitted (must be ≤7 days and tapered down to prednisone ≤ 20 mg oral/day or steroid equivalent by first day of anthracycline treatment). Clinical exceptions in regards to steroid management can be made after discussion with PI.
ECOG performance status of 0 to 2.

Exclusion

Active systemic therapy for another malignancy (other than indolent B-cell lymphoma) within 2 years; local/regional therapy with curative intent such as surgical resection or localized radiation within 2 years of treatment is permitted.
Active concurrent malignancy with the exception of basal cell or localized squamous cell skin carcinoma, localized prostate cancer, or other localized carcinomas such as carcinoma in situ of cervix, breast, or bladder.
Any uncontrolled illness that in the opinion of the investigator would preclude administration of curative intent chemoimmunotherapy (e.g. significant active infections, hypertension, angina, arrhythmias, pulmonary disease, or autoimmune dysfunction).
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization within 2 weeks prior to Cycle 1, Day 1.
Psychiatric illness or social situations that would limit the patient's ability to tolerate and/or comply with study requirements.

What this trial measures

  • Incidence of positive cerebral spinal fluid/CSF ctDNAup to 2 years

    The primary objective is to describe the incidence of positive CSF ctDNA in participants at high-risk for CNS relapse