Testing blood for cancer DNA in patients with B-cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to determine the prevalence of circulating tumor DNA (ctDNA) in the cerebral spinal fluid (CSF) of patients with B-cell lymphoma who are at high risk for central nervous system (CNS) relapse. It will assess how many of these patients test positive for CSF ctDNA while standard tests show no CNS involvement. Additionally, the study will track the occurrence of CNS relapse in patients with and without detected CSF ctDNA. The findings could provide insights into the effectiveness of ctDNA testing in predicting CNS relapse.

Why it matters

Who can join: the full rules

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 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 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.

Where it's running

• Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Bergen (Limited Protocol Activities)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Westchester (Limited Protocol Activities)
  Harrison, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center (All Protocol Activites)
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Jennifer Lue, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Jennifer Lue, MD
• Email: luej@mskcc.org
• Phone: 646-608-4160

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.