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

Mantle Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05255354
• Other study ID #: ADAP-014
• Secondary ID: CCT5065
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: March 11, 2027

Study information

• Verified date: January 2023
• Source: Adaptive Biotechnologies
• Contact: Heidi Simmons, PhD
• Phone: 206-279-2591
• Email: hsimmons[@]adaptivebiotech.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 11, 2027
• Est. primary completion date: September 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Follicular Lymphoma
• Lymphoma
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma

Intervention

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

Locations

Country	Name	City	State
United States	Stanford Cancer Center	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Adaptive Biotechnologies	Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Secondary Objective: Correlation of minimal residual disease and tumor burden	-Determine the correlation between quantified MRD and metabolic tumor volume (MTV)	0-18 months
Secondary	Secondary Objective continued: Looking at clinical information of minimal residual disease	-Determine the clinical utility of MRD assessments in an exploratory analysis	0-18 months
Secondary	Secondary Objective continued: Additional correlations	-Determine the correlation between ctDNA-based and CTC-based MRD assessments in DLBCL/FL/MCL	0-18 months