Assessing ctDNA for monitoring lymphoma patients receiving CAR therapy
Optimizing ctDNA-based MRD Assessment in DLBCL, MCL, and FL Patients Undergoing CAR Therapy
This study is testing if measuring tumor DNA in the blood can help doctors keep track of lymphoma patients receiving CAR therapy and see if their cancer is coming back sooner than traditional scans.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Adaptive Biotechnologies Industry-sponsored |
| Drugs / interventions | CAR-T |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT05255354 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with confirmed diagnoses of DLBCL, MCL, or FL who are about to undergo CAR-T therapy and have available tissue samples for genomic analysis.
Not a fit: Patients without available archival or fresh tissue samples for clonotype identification will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved monitoring and earlier detection of disease recurrence in lymphoma patients undergoing CAR therapy.
How similar studies have performed: Previous studies have shown promise in using ctDNA for monitoring treatment responses in various cancers, suggesting potential success for this approach in lymphoma.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Palo Alto, California
- Stanford Cancer Center — Palo Alto, California, United States (Recruiting)
Study contacts
- Study coordinator: Heidi Simmons, PhD
- Email: hsimmons@adaptivebiotech.com
- Phone: 206-279-2591
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.