RecruitingNCT05255354

Optimizing ctDNA-based MRD Assessment in DLBCL, MCL, and FL Patients Undergoing CAR Therapy


Sponsor

Adaptive Biotechnologies

Enrollment

300 participants

Start Date

Jun 1, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

In this study, invesigators propose to analyze 150 DLBCL patients, 50 MCL patients, and 100 FL patients to determine the clinical utility of ctDNA- as well as circulating tumor cell (CTC)-based MRD assessment in CAR therapy patients. The project detailed in this protocol will utilize the clonoSEQ platform as specific quantification of residual DLBCL/FL/MCL and correlate its results with radiologic assessment of disease and clinical outcomes. Invesitgators predict there will be a strong correlation between ctDNA and PET/CT and dynamic changes in ctDNA will precede radiologic evidence of disease recurrence in patients following CAR therapy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is tracking how well a specialized blood test (called ctDNA, which detects cancer DNA in the blood) can predict treatment response in patients with certain B-cell lymphomas who are receiving CAR-T cell therapy. CAR-T therapy involves engineering a patient's own immune cells to attack cancer. The goal is to understand whether ctDNA testing can provide earlier and more accurate information than standard scans. **You may be eligible if...** - You have been diagnosed with follicular lymphoma, large B-cell lymphoma, or mantle cell lymphoma - You are scheduled to receive an FDA-approved CAR-T cell therapy for your lymphoma - You have measurable disease visible on a PET scan at the time of enrollment - A tissue sample from your diagnosis or relapse is available for genetic analysis **You may NOT be eligible if...** - No archival or fresh tissue sample is available to identify your cancer's genetic fingerprint for tracking Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEClonoSEQ

Cancer clonotype sequences are identified in diagnostic 'ID' samples and then sequence frequencies are measured in follow up samples.


Locations(1)

Stanford Cancer Center

Palo Alto, California, United States

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NCT05255354


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