Actively Recruiting
Optimizing ctDNA-based MRD Assessment in DLBCL, MCL, and FL Patients Undergoing CAR Therapy
Led by Adaptive Biotechnologies · Updated on 2024-08-22
300
Participants Needed
1
Research Sites
239 weeks
Total Duration
On this page
Sponsors
A
Adaptive Biotechnologies
Lead Sponsor
S
Stanford University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Optimizing ctDNA-based MRD Assessment in DLBCL, MCL, and FL Patients Undergoing CAR Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Immunophenotypically confirmed diagnosis of follicular lymphoma (FL), diffuse large B cell lymphoma (LBCL) including transformed FL and primary mediastinal B-cell lymphoma, or mantle cell lymphoma (MCL)
- Undergoing commercially approved CAR-T therapy in accordance with FDA indication with enrollment prior to CAR infusion
- CAR-T product must meet manufacturer specifications
- PET measurable disease at the time CAR treatment is prescribed
- Has sample from diagnosis or relapse available for genomic DNA extraction to identify patient's clonotype via clonoSEQ
You will not qualify if you...
- Lack of archival diagnostic or fresh/archival relapse tissue for clonotype determination
- Patients without identifiable clonotype by clonoSEQ will be removed from study analysis but samples stored
- No exclusions based on gender, race, ethnicity, sexual orientation, or other demographics
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Stanford Cancer Center
Palo Alto, California, United States, 94306
Actively Recruiting
Research Team
H
Heidi Simmons, PhD
CONTACT
M
Monica Gallucci
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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