Optimizing ctDNA-based MRD Assessment in DLBCL, MCL, and FL Patients Undergoing CAR Therapy
2 other identifiers
observational
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2022
CompletedFirst Posted
Study publicly available on registry
February 24, 2022
CompletedStudy Start
First participant enrolled
June 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedAugust 22, 2024
August 1, 2024
3.3 years
February 9, 2022
August 21, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Primary Outcome: Predicting Progression Free Survival
Ability of ctDNA MRD assessment to predict progression-free survival (PFS) at 6 months following CAR infusion in DLBCL, FL and MCL patients.
0-18 months
Secondary Outcomes (3)
Secondary Objective: Correlation of minimal residual disease and tumor burden
0-18 months
Secondary Objective continued: Looking at clinical information of minimal residual disease
0-18 months
Secondary Objective continued: Additional correlations
0-18 months
Study Arms (3)
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
Cancer clonotype sequences are identified in diagnostic 'ID' samples and then sequence frequencies are measured in follow up samples.
Eligibility Criteria
Subjects ≥ 18 years of age, with DLBCL, FL, or MCL who are undergoing standard-of-care CAR therapy.
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Adaptive Biotechnologieslead
- Stanford Universitycollaborator
Study Sites (1)
Stanford Cancer Center
Palo Alto, California, 94306, United States
Biospecimen
Patients will prospectively have blood samples collected prior to lymphodepleting chemotherapy and during the first 6-12 months after CAR infusion for MRD analysis. Patients will have their original tissue biopsy or bone marrow (which shows evidence of disease) analyzed to determine their clonotype for future assessments on peripheral blood sample.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Heidi Simmons, PhD
Adaptive Biotechnologies
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2022
First Posted
February 24, 2022
Study Start
June 1, 2022
Primary Completion
September 1, 2025
Study Completion (Estimated)
December 31, 2026
Last Updated
August 22, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share