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

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

Phase 2 Interventional Memorial Sloan Kettering Cancer Center · NCT06736613

This study is testing if a blood test for cancer DNA can help identify patients with B-cell lymphoma who are at risk of having their cancer come back in the brain or spinal cord, even when other tests show no signs of it.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment50 (estimated)
Ages18 Years and up
SexAll
SponsorMemorial Sloan Kettering Cancer Center Academic / other
Drugs / interventionsradiation, prednisone
Locations7 sites (Basking Ridge, New Jersey and 6 other locations)
Trial IDNCT06736613 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older diagnosed with specific high-risk forms of B-cell lymphoma, particularly those with a CNS IPI score indicating a high risk for CNS relapse.

Not a fit: Patients with low-risk B-cell lymphoma or those not meeting the specific high-risk criteria for CNS relapse may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve early detection of CNS relapse in B-cell lymphoma patients, potentially leading to better treatment outcomes.

How similar studies have performed: While the approach of using ctDNA testing is gaining traction, this specific application in B-cell lymphoma and CNS relapse is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Basking Ridge, New Jersey and 6 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Diffuse Large B Cell LymphomaHigh-grade B-cell LymphomaStage III High Grade B-Cell LymphomaStage IV High Grade B-Cell LymphomaDLBCL - Diffuse Large B Cell LymphomaIntravascular Large B-Cell LymphomaDiffuse Large B Cell Lymphoma of BreastDiffuse Large B Cell Lymphoma of Testis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.