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Observational Study of ClonoSEQ in Lymphoma Patients Undergoing CAR Therapy

This observational study is looking at how well a test called ClonoSEQ can predict if your follicular lymphoma (FL), diffuse large B cell lymphoma (DLBCL), or mantle cell lymphoma (MCL) will return after you've had CAR T-cell therapy. Researchers will analyze samples from 300 patients to see if changes in circulating tumor DNA (ctDNA) – tiny pieces of cancer DNA in your blood – can show disease recurrence earlier than traditional scans. The study aims to see if ClonoSEQ results correlate with imaging and clinical outcomes. You may be eligible if you are 18 or older and have a confirmed diagnosis of FL, DLBCL, or MCL and are receiving commercially approved CAR T-cell therapy. The study's success will be measured by how well ClonoSEQ predicts progression-free survival (how long you live without your cancer getting worse) over 0-18 months. The recruitment status is unclear.

Study design
This is an observational study involving 300 participants with follicular lymphoma, diffuse large B cell lymphoma, or mantle cell lymphoma.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to measure progression-free survival for 0-18 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05255354

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

Recruiting
Not specifiedAges 18+Observational
Adaptive Biotechnologies
~300 participants
Updated 2024-08-22 on ClinicalTrials.gov
What's tested:ClonoSEQ

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Outcome: Predicting Progression Free Survival
Measured over 0-18 months

Conditions

Follicular Lymphoma
Diffuse Large B Cell Lymphoma
Mantle Cell Lymphoma

Explore related trials

Diffuse Large B-Cell LymphomaFollicular LymphomaHematologic NeoplasmMantle Cell LymphomaPrimary Mediastinal Large B-Cell Lymphoma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Heidi Simmons, PhD · STUDY_DIRECTOR · Adaptive Biotechnologies

Who to contact

Heidi Simmons, PhD
[email protected]
206-279-2591
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Primary Outcome: Predicting Progression Free Survival0-18 months

    Ability of ctDNA MRD assessment to predict progression-free survival (PFS) at 6 months following CAR infusion in DLBCL, FL and MCL patients.