NCT05255354

Optimizing ctDNA-based MRD Assessment in DLBCL, MCL, and FL Patients Undergoing CAR Therapy

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Adaptive Biotechnologies · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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

• Follicular Lymphoma
• Diffuse Large B Cell Lymphoma
• Mantle Cell Lymphoma

Interventions

Type	Name	Description
DEVICE	ClonoSEQ	Cancer clonotype sequences are identified in diagnostic 'ID' samples and then sequence frequencies are measured in follow up samples.

Timeline

• Start date: 2022-06-01
• Primary completion: 2025-09-01
• Completion: 2026-12-31
• First posted: 2022-02-24
• Last updated: 2024-08-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study