An observational study in Follicular Lymphoma, Diffuse Large B Cell Lymphoma and Mantle Cell Lymphoma, sponsored by Adaptive Biotechnologies. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-22.
Sponsored by Adaptive Biotechnologies · Observational
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.
964 studies on the registry are indexed under Lymphoma, Follicular; 242 are open to participants now.
This study's planned enrollment of 300 is above the median of 200 across 106 observational studies indexed under Lymphoma, Follicular.
Browse Lymphoma, Follicular studies →Adaptive Biotechnologies is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
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Subjects ≥ 18 years of age, with DLBCL, FL, or MCL who are undergoing standard-of-care CAR therapy.
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Exclusion Criteria:
For DLBCL patients, prospective blood samples will be collected, in provided collection kits, at: pre-lymphodepletion chemotherapy, Day+14, Day+28, Day+90, Day+180, and potentially at relapse following CAR infusion. For DLBCL, PET/CT scan images done prior to CAR19 therapy, Day 28 post-infusion, 3 months post-infusion, and 6 months post-infusion of CAR19 cells
Device: ClonoSEQ
For FL patients, prospective blood samples will be collected, in provided collection kits, at: pre-lymphodepletion chemotherapy, Day+14, Day+28, Day+90, Day+180, Day+365, and potentially D+547 and at relapse following CAR infusion. For FL patients, PET/CT scan images done prior to CAR19 therapy, Day 28 post-infusion, 3 months post-infusion, and 6 months post-infusion of CAR19 cells
Device: ClonoSEQ
For MCL patients, prospective blood samples will be collected, in provided collection kits, at: pre-lymphodepletion chemotherapy, Day+14, Day+28, Day+90, Day+180, Day+365, and potentially D+547 and at relapse following CAR infusion. For MCL patients, PET/CT scan images done prior to CAR19 therapy, Day 28 post-infusion, 3 months post-infusion, and 6 months post-infusion of CAR19 cells
Device: ClonoSEQ
Cancer clonotype sequences are identified in diagnostic 'ID' samples and then sequence frequencies are measured in follow up samples.
Primary Outcome: Predicting Progression Free Survival
Ability of ctDNA MRD assessment to predict progression-free survival (PFS) at 6 months following CAR infusion in DLBCL, FL and MCL patients.
Time frame: 0-18 months
Secondary Objective: Correlation of minimal residual disease and tumor burden
-Determine the correlation between quantified MRD and metabolic tumor volume (MTV)
Time frame: 0-18 months
Secondary Objective continued: Looking at clinical information of minimal residual disease
-Determine the clinical utility of MRD assessments in an exploratory analysis
Time frame: 0-18 months
Secondary Objective continued: Additional correlations
-Determine the correlation between ctDNA-based and CTC-based MRD assessments in DLBCL/FL/MCL
Time frame: 0-18 months
Plan to share: No
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Adaptive Biotechnologies