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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Adaptive Biotechnologies
Study ID
NCT05255354
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 1, 2022
Status verified
Aug 2024
Primary completion
Sep 1, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
300 participants (estimated)

Arms

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

Primary Outcome Measure

Primary Outcome: Predicting Progression Free Survival [ Time Frame: 0-18 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford Cancer CenterPalo AltoCalifornia94306
David Miklos, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Stanford Cancer Center· Palo Alto, CA

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