Status:
RECRUITING
Optimizing ctDNA-based MRD Assessment in DLBCL, MCL, and FL Patients Undergoing CAR Therapy
Lead Sponsor:
Adaptive Biotechnologies
Collaborating Sponsors:
Stanford University
Conditions:
Follicular Lymphoma
Diffuse Large B Cell Lymphoma
Eligibility:
All Genders
18+ years
Brief 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 as...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05255354
Start Date
June 1 2022
End Date
December 31 2026
Last Update
August 22 2024
Active Locations (1)
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1
Stanford Cancer Center
Palo Alto, California, United States, 94306