Health Trials

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

ConditionsDiffuse 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 TestisHIV-associated Diffuse Large B Cell LymphomaDouble Expressor DLBCL
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

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

Treatments tested in this trial

  • Cerebral Spinal Fluid ctDNA

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators

Memorial Sloan Kettering Cancer Center

Lead sponsor

Source ClinicalTrials.gov