RecruitingPhase 1NCT04468841

Measuring Cell-Free DNA (cfDNA) Levels in People With Follicular Lymphoma

An Exploratory Study to Correlate the Level of Cell-free DNA With Response to First-line Treatment in Patients With Follicular Lymphoma

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

100 participants

Start Date

Jul 8, 2020

Study Type

INTERVENTIONAL

Conditions

Follicular Lymphoma

Summary

The researchers are doing this study to measure and test cell-free DNA (cfDNA) in the blood before, during, and after first-line treatment for follicular lymphoma. They will look at whether cfDNA levels are related to a person's response to the usual first-line treatment for follicular lymphoma. Researchers also want to understand how different genetic changes in follicular lymphoma relate to a person's response to the usual first-line treatment.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

≥18 years of age at time of signing informed consent. Consent is permitted from either the participant or from a Legally Authorized Representative (LAR) on their behalf.
Histology-confirmed follicular lymphoma grade 1-3a, verified by the enrolling institution
Ability to adhere to the study visit schedule and all the protocol requirements
Measurable FDG-avid disease
Not applicable for retrospective patients in CR

Exclusion Criteria1

Patients receiving second or greater line of therapy (except in retrospective cohort of long-term survivors of FL \[i.e. \>10 years out from frontline treatment\])

Interventions

DIAGNOSTIC_TESTcfDNA testing

peripheral blood samples collected before initiation of standard therapy, after 2 cycles of therapy, at the completion of 6-8 cycles of induction therapy, and then every 6 months for a total of 2 years from the initiation of therapy using a cfDNA assay. For retrospective patients, blood samples will be collected once.

OTHERsample of saliva or fingernail clipping

collected in clinic one time

DIAGNOSTIC_TESTpre-treatment test specimen

From bone marrow, blood, lymph node, or alternate site to identify tumor-specific mutations. For retrospective patients initial tumor tissue (if available).

DIAGNOSTIC_TESTPET/CT, CT, or MRI testing

PET/CT scans are required at baseline and at the patient's end-of-treatment visit. The other standard-of-care scan timepoints can be performed using PET/CT, dedicated CT, or MRI per the treating investigator's discretion.