Follicular LymphomaNCT05255354
Optimizing ctDNA-based MRD Assessment in DLBCL, MCL, and FL Patients Undergoing CAR Therapy
An observational study of Follicular Lymphoma and Diffuse Large B Cell Lymphoma, run by Adaptive Biotechnologies at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma, Diffuse Large B Cell Lymphoma, Mantle Cell Lymphoma
- What is being tested?
- ClonoSEQ
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects ≥ 18 years of age, with DLBCL, FL, or MCL who are undergoing standard-of-care CAR therapy.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Monica Gallucci contact
United States1 site, 1 recruiting
- Recruiting
Stanford Cancer Center
Palo Alto, California, 94306
Paul Hanson, hansonpj@stanford.edu
David Miklos, MD, PhD
About this study
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.
- Being tested
- ClonoSEQ
- Medical subject headings
- Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClonoSEQDevice
Cancer clonotype sequences are identified in diagnostic 'ID' samples and then sequence frequencies are measured in follow up samples.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: ClonoSEQ | |
| 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 Receives: Device: ClonoSEQ | |
| 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 Receives: Device: ClonoSEQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-18 months
Secondary outcomes (3)
Secondary Objective: Correlation of minimal residual disease and tumor burden
-Determine the correlation between quantified MRD and metabolic tumor volume (MTV)
Measured: 0-18 months
Secondary Objective continued: Looking at clinical information of minimal residual disease
-Determine the clinical utility of MRD assessments in an exploratory analysis
Measured: 0-18 months
Secondary Objective continued: Additional correlations
-Determine the correlation between ctDNA-based and CTC-based MRD assessments in DLBCL/FL/MCL
Measured: 0-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start1 Jun 2022
- Primary completion1 Sep 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicular LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adaptive Biotechnologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stanford University
- Responsible party
- Sponsor
- Investigators
- Heidi Simmons, PhD, Study director, Adaptive Biotechnologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255354
- Sponsor's protocol ID
- ADAP-014
- Other IDs
- CCT5065
- Status last verified
- Aug 2024
- First submitted
- 9 Feb 2022
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing ctDNA-based MRD Assessment in DLBCL, MCL, and FL Patients Undergoing CAR Therapy
- ClinicalTrials.gov ID
- NCT05255354
- Acronym / sponsor ID
- ADAP-014
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Adaptive BiotechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- Stanford University
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diffuse Large B Cell Lymphoma | – | Device: ClonoSEQFor 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 | – | Device: ClonoSEQFor 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 | – | Device: ClonoSEQFor 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects ≥ 18 years of age, with DLBCL, FL, or MCL who are undergoing standard-of-care CAR therapy.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClonoSEQCancer clonotype sequences are identified in diagnostic 'ID' samples and then sequence frequencies are measured in follow up samples. | Device | Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma |
Primary outcome
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.
3 secondary outcomes
Secondary Objective: Correlation of minimal residual disease and tumor burden
Time frame: 0-18 months
Secondary Objective continued: Looking at clinical information of minimal residual disease
Time frame: 0-18 months
Secondary Objective continued: Additional correlations
Time frame: 0-18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Monica Gallucci contact
Heidi Simmons, PhD study director
Adaptive Biotechnologies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Follicular Lymphoma and Diffuse Large B Cell Lymphoma, run by Adaptive Biotechnologies at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heidi Simmons, PhD (206-279-2591, hsimmons@adaptivebiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome: Predicting Progression Free Survival (time frame: 0-18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.