RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2022-06-01
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05255354

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * CAR-T product must meet manufacturer specifications
  3. * PET measurable disease at the time a decision is made to prescribe CAR treatment
  4. * Has sample from diagnosis or relapse available for genomic DNA extraction to identify patient's clonotype via clonoSEQ (see lab manual for details)
  1. * 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.
  2. * No patients are to be excluded on the basis of gender, race, ethnic background, sexual orientation, or other demographic characteristics.

Contacts and Locations

Study Contact

Heidi Simmons, PhD
CONTACT
206-279-2591
hsimmons@adaptivebiotech.com
Monica Gallucci
CONTACT
mgallucci@adaptivebiotech.com

Principal Investigator

Heidi Simmons, PhD
STUDY_DIRECTOR
Adaptive Biotechnologies

Study Locations (Sites)

Stanford Cancer Center
Palo Alto, California, 94306
United States

Collaborators and Investigators

Sponsor: Adaptive Biotechnologies

  • Heidi Simmons, PhD, STUDY_DIRECTOR, Adaptive Biotechnologies

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-01
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2022-06-01
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

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