Recruiting

ctDNA-based MRD Assessment

Sponsor:

Adaptive Biotechnologies

Code:

NCT05255354

Conditions

Follicular Lymphoma

Diffuse Large B Cell Lymphoma

Mantle Cell Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ClonoSEQ

Study Details

Brief 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

Study ID

NCT05255354

Start date

Jun 1, 2022

Status verified date

Aug, 2024

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Sep 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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

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

Interventions

ClonoSEQ

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Heidi Simmons, PhD

206-279-2591hsimmons@adaptivebiotech.com

Monica Gallucci

mgallucci@adaptivebiotech.com

Locations

Stanford Cancer Center

Recruiting

Palo Alto, California, United States, 94306

Contacts

Paul Hanson

hansonpj@stanford.edu

Principal Investigator:

David Miklos, MD, PhD

More Information

Sponsor

Adaptive Biotechnologies

Last update posted

Aug 22, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Adaptive Biotechnologies on 2024-08-22.