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

Plain Language Summary

Simplified for easier understanding

This study is measuring cell-free DNA (small fragments of DNA released by cancer cells into the blood) in patients with follicular lymphoma — a slow-growing blood cancer. Researchers want to use this blood test to better track the disease and predict how patients will respond to treatment. **You may be eligible if:** - You are 18 or older - You have confirmed follicular lymphoma (grade 1 to 3a) - You are receiving first-line (initial) treatment for your lymphoma - You have measurable disease on a PET scan **You may NOT be eligible if:** - You are receiving your second or later line of therapy (unless you are a long-term survivor who has been in remission for more than 10 years after initial treatment) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.