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

Sponsor
Adaptive Biotechnologies (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05255354
Collaborator
Stanford University (Other)
300
Enrollment
1
Location
57
Anticipated Duration (Months)
5.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: ClonoSEQ

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Optimizing ctDNA-based MRD Assessment in DLBCL, MCL, and FL Patients Undergoing CAR Therapy
Anticipated Study Start Date :
Jun 11, 2022
Anticipated Primary Completion Date :
Sep 11, 2023
Anticipated Study Completion Date :
Mar 11, 2027

Arms and Interventions

ArmIntervention/Treatment
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

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

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

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

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

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

Outcome Measures

Primary Outcome Measures

  1. Primary Outcome: Predicting Progression Free Survival [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 Outcome Measures

  1. Secondary Objective: Correlation of minimal residual disease and tumor burden [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 [0-18 months]

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

  3. Secondary Objective continued: Additional correlations [0-18 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Stanford Cancer CenterPalo AltoCaliforniaUnited States94306

Sponsors and Collaborators

  • Adaptive Biotechnologies
  • Stanford University

Investigators

  • Study Director: Heidi Simmons, PhD, Adaptive Biotechnologies

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Adaptive Biotechnologies
ClinicalTrials.gov Identifier:
NCT05255354
Other Study ID Numbers:
  • ADAP-014
  • CCT5065
First Posted:
Feb 24, 2022
Last Update Posted:
Apr 5, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 5, 2022