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

Registration Number
NCT06736613
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
50
Inclusion Criteria
  • 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:

    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

  • 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.

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Exclusion Criteria
  • 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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (7)

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

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