A Study of Circulating Tumor DNA (ctDNA) Testing for People With B-Cell Lymphoma
NCT ID: NCT06736613
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
50 participants
INTERVENTIONAL
2024-12-11
2027-12-11
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Participants with Diffuse large B-cell lymphoma (DLBCL) i
Participants will be deemed clinically high-risk for CNS relapse. Participants will be considered to be high-risk for CNS relapse as determined by CNS-IPI score, pathological characteristics such as the presence of MYC, BCL2 and/or BCL6 translocations and specific extranodal involvement such as breast, renal, adrenal, nasopharyngeal, epidural/paraspinal involvement
Cerebral Spinal Fluid ctDNA
MSK's Diagnostic Molecular Pathology core has developed and validated a CSF ctDNA assay which has been approved by New York State Department of Health as of 2019
Interventions
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Cerebral Spinal Fluid ctDNA
MSK's Diagnostic Molecular Pathology core has developed and validated a CSF ctDNA assay which has been approved by New York State Department of Health as of 2019
Eligibility Criteria
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Inclusion Criteria
* 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:
1. Diffuse Large B-cell Lymphoma (DLBCL) with CNS IPI score ≥ 4.
2. Stage III/IV High Grade B-cell lymphoma (HGBCL) with MYC, BCL2, and/or BCL6 translocations
3. Primary DLBCL of Breast
4. Primary DLBCL of Testis
5. Primary Cutaneous DLBCL, Leg Type
6. Intravascular Large B-cell Lymphoma
7. Stage III/IV HIV-associated DLBCL
8. Double expressor DLBCL (co-expression of MYC ≥ 40% and BCL2 ≥ 50% without translocations) with a CNS IPI score ≥ 3
9. DLBCL with the following extranodal involvement AND CNS IPI score ≥ 3:
i. Adrenal ii. Breast iii. Bone Marrow with pathological overt morphological involvement iv. Epidural/Paraspinal v. Nasal/parasinus with local invasion such as bone destruction vi. Renal viii. Uterine ix. Testis xi. Skull involvement without direct invasion into CNS/brain parenchyma
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Jennifer Lue, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Rockville Centre, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Jennifer Lue, MD
Role: primary
Jennifer Lue, MD
Role: primary
Jennifer Lue, MD
Role: primary
Jennifer Lue, MD
Role: primary
Jennifer Lue, MD
Role: primary
Jennifer Lue, MD
Role: primary
Jennifer Lue, MD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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24-336
Identifier Type: -
Identifier Source: org_study_id