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

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT06736613
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cerebral Spinal Fluid ctDNA — DIAGNOSTIC_TEST
    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

Study Details

The purpose of this study is to find out how many people with B-cell lymphoma who are at high risk for central nervous system/CNS relapse test positive for cerebral spinal fluid/CSF ctDNA but test negative for CNS involvement using standard tests. The study will also look at how often CNS relapse happens in people with and without detected CSF ctDNA.

Key Dates

Start date
Dec 11, 2024
Status verified
Dec 2025
Primary completion
Dec 11, 2027
Completion
Dec 11, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 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

Primary Outcome Measure

Incidence of positive cerebral spinal fluid/CSF ctDNA [ Time Frame: up to 2 years ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Jennifer Lue, MD
646-608-4160
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Jennifer Lue, MD
646-608-4160
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Jennifer Lue, MD
646-608-4160
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)CommackNew York11725
Jennifer Lue, MD
646-608-4160
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Jennifer Lue, MD
646-608-4160
Memorial Sloan Kettering Cancer Center (All Protocol Activites)New YorkNew York10065
Jennifer Lue, MD
646-608-4160
Memorial Sloan Kettering Nassau (Limited Protocol Activities)Rockville CentreNew York11553
Jennifer Lue, MD
646-608-4160

Find similar trials in Basking Ridge, NJ

By research site
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activites)· New York, NY

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