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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed Informed Consent.

Ability and willingness to comply with the requirements of the study protocol.

Age ≥ 18 years old.

Diffuse Large B-cell Lymphoma (DLBCL) with CNS IPI score ≥ 4.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Participants with Diffuse large B-cell lymphoma (DLBCL) iExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of positive cerebral spinal fluid/CSF ctDNA

The primary objective is to describe the incidence of positive CSF ctDNA in participants at high-risk for CNS relapse

Time frame
up to 2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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