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


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Trial ID: NCT05255354


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.

Official Title

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

Stanford Investigator(s)

David Miklos
David Miklos

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)


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.


device: ClonoSEQ


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Janet McDowell
+1 650-725-1647

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