Actively Recruiting
Cerebral Spinal Fluid Circulating Tumor DNA (ctDNA) Analysis in Patients With Aggressive B-cell Lymphoma Receiving Front Line Therapy and at High Risk for Central Nervous System Relapse
Led by Memorial Sloan Kettering Cancer Center · Updated on 2025-12-18
50
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying people with aggressive B-cell lymphoma who are at high risk for central nervous system (CNS) relapse. They want to find out how many of these patients test positive for circulating tumor DNA (ctDNA) in their cerebral spinal fluid (CSF) even when standard tests show no CNS involvement. The study also aims to compare how often CNS relapse occurs in patients with and without detected CSF ctDNA. Participants considered at high risk for CNS relapse are identified based on clinical factors such as CNS-IPI score, specific genetic changes like MYC, BCL2, and BCL6 translocations, and involvement of certain extranodal sites including breast, renal, adrenal, nasopharyngeal, and epidural/paraspinal areas. The study uses a CSF ctDNA test developed by Memorial Sloan Kettering Cancer Center's Diagnostic Molecular Pathology core, which is approved by the New York State Department of Health. All participants will undergo this diagnostic testing while receiving standard frontline therapy for their lymphoma. During the study, participants will be monitored to see if the CSF ctDNA test is positive and followed for up to two years to observe the incidence of CNS relapse. Researchers will collect data on CSF ctDNA presence and track clinical outcomes related to CNS relapse. Participants must be able to undergo lumbar puncture safely for CSF collection and will be assessed regularly during their standard treatment. The total participation time will vary depending on individual treatment and follow-up schedules.
CONDITIONS
Brief Title
A Study of Circulating Tumor DNA (ctDNA) Testing for People With B-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent.
- Ability and willingness to follow the study protocol.
- Age 18 years or older.
- Diagnosed with high-risk B-cell lymphoma types, including Diffuse Large B-cell Lymphoma with CNS-IPI score ≥ 4, Stage III/IV High Grade B-cell lymphoma with MYC, BCL2, and/or BCL6 translocations, Primary DLBCL of Breast, Testis, or Cutaneous Leg Type, Intravascular Large B-cell Lymphoma, Stage III/IV HIV-associated DLBCL, or Double expressor DLBCL with CNS-IPI score ≥ 3.
- Presence of specific extranodal involvement with CNS-IPI score ≥ 3.
- Transformed DLBCL from indolent lymphoma without prior CNS involvement.
- Planned to receive standard chemoimmunotherapy.
- Able to safely undergo lumbar puncture without contraindications.
- No prior systemic therapy for aggressive B-cell lymphoma.
- ECOG performance status between 0 and 2.
You will not qualify if you...
- Receiving active systemic therapy for another malignancy (except certain localized cancers) within 2 years.
- Having active concurrent malignancy except for specific localized skin or prostate cancers.
- Any uncontrolled illness that would prevent chemoimmunotherapy.
- Known active infections requiring treatment or recent major infection.
- Psychiatric or social issues limiting ability to comply with study requirements.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants undergo cerebral spinal fluid (CSF) ctDNA testing to evaluate tumor DNA presence as part of diagnostic assessment.
1 to 2 visits depending on clinical assessments
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Rockville Centre, New York, United States, 11553
Actively Recruiting
Research Team
J
Jennifer Lue, MD
A
Ariela Noy, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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