Assessing ctDNA for monitoring lymphoma patients receiving CAR therapy

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 evaluate the clinical utility of circulating tumor DNA (ctDNA) and circulating tumor cell (CTC) assessments in patients with Diffuse Large B Cell Lymphoma (DLBCL), Mantle Cell Lymphoma (MCL), and Follicular Lymphoma (FL) undergoing CAR therapy. Investigators will analyze a total of 300 patients using the clonoSEQ platform to quantify residual disease and correlate these findings with radiologic assessments and clinical outcomes. The hypothesis is that changes in ctDNA levels will precede radiologic evidence of disease recurrence, providing a more timely indication of patient status post-therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Immunophenotypically confirmed diagnosis of follicular lymphoma (FL), Immunophenotypically confirmed diagnosis of Large B Cell Lymphoma (LBCL) (including transformed FL and Primary Mediastinal B-cell Lymphoma) OR Immunophenotypically confirmed diagnosis of mantle cell lymphoma (MCL) undergoing commercially approved CAR-T therapy in accordance with FDA indication with enrollment in this trial prior to CAR infusion
* CAR-T product must meet manufacturer specifications
* PET measurable disease at the time a decision is made to prescribe CAR treatment
* Has sample from diagnosis or relapse available for genomic DNA extraction to identify patient's clonotype via clonoSEQ (see lab manual for details)

Exclusion Criteria:

* Lack of archival diagnostic or fresh/archival relapse tissue for purposes of determining patient's lymphoma clonotype. Given that 5-10% of patients cannot have a clonotype identified by clonoSEQ, those patients will be removed from the study and excluded from analysis, but their samples will continued to be stored for future analysis as improvements to the analysis platform are made.
* No patients are to be excluded on the basis of gender, race, ethnic background, sexual orientation, or other demographic characteristics.

Where it's running

• Stanford Cancer Center
  Palo Alto, California, United States Recruiting

Study contacts

• Study coordinator: Heidi Simmons, PhD
• Email: hsimmons@adaptivebiotech.com
• Phone: 206-279-2591

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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.