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NCT Number: NCT05255354

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford Cancer Center

Palo Alto, California, 94306, United States

Location status: Recruiting

Location contact

David Miklos, MD, PhD

PRINCIPAL_INVESTIGATOR

Paul Hanson

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ClonoSEQ

Device

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

Primary outcomes

  1. Primary Outcome: Predicting Progression Free Survival

    Time frame: 0-18 months

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

Secondary outcomes

  1. Secondary Objective: Correlation of minimal residual disease and tumor burden

    Time frame: 0-18 months

    -Determine the correlation between quantified MRD and metabolic tumor volume (MTV)

  2. Secondary Objective continued: Looking at clinical information of minimal residual disease

    Time frame: 0-18 months

    -Determine the clinical utility of MRD assessments in an exploratory analysis

  3. Secondary Objective continued: Additional correlations

    Time frame: 0-18 months

    -Determine the correlation between ctDNA-based and CTC-based MRD assessments in DLBCL/FL/MCL

Study contacts

Contact information is provided by the study sponsor or research team.

Heidi Simmons, PhD

CONTACT

[email protected]

206-279-2591

Monica Gallucci

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Adaptive Biotechnologies

Industry

Collaborators

  • Stanford University

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Feb 24, 2022
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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