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

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.

Study Overview

• Status: Recruiting
• Conditions: Follicular Lymphoma
• Intervention / Treatment: Other: sample of saliva or fingernail clipping; Diagnostic test: pre-treatment test specimen; Diagnostic test: PET/CT, CT, or MRI testing; Diagnostic test: cfDNA testing

Detailed Description

This is a non-therapeutic protocol aimed to assess the ability of the s cfDNA assay to detect clinical response in FL when compared to conventional approaches for assessing response, such as PET-CT scans.

Study assessments will include: 1) identification of the mutations present in the primary tumor, 2) identification of these mutations in the 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 patients who receive RT, peripheral blood samples will be collected before initiation of RT, and then 3 months, 6 months, 12 months, 18 months and 24 months post RT using a s cfDNA assay.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Paola Ghione, MD; Phone Number: 646-608-4263; Email: ghionep@mskcc.org
• Study Contact Backup: Name: Maria Arcila, MD; Phone Number: 212-639-7879

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Recruiting
      • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
      • Contact: Paola Ghione, MD; Phone Number: 646-608-4263
    • Middletown, New Jersey, United States, 07748
      • Recruiting
      • Memorial Sloan Kettering Monmouth (All Protocol Activities)
      • Contact: Paola Ghione, MD; Phone Number: 646-608-4263
    • Montvale, New Jersey, United States, 07645
      • Recruiting
      • Memorial Sloan Kettering Bergen (All Protocol Activities)
      • Contact: Paola Ghione, MD; Phone Number: 646-608-4263
  • New York
    • Commack, New York, United States, 11725
      • Recruiting
      • Memorial Sloan Kettering Commack (All Protocol Activities)
      • Contact: Paola Ghione, MD; Phone Number: 646-608-4263
    • Harrison, New York, United States, 10604
      • Recruiting
      • Memorial Sloan Kettering Westchester (All Protocol Activities)
      • Contact: Paola Ghione, MD; Phone Number: 646-608-4263
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center (All protocol activities)
      • Contact: Paola Ghione, MD; Phone Number: 646-608-4263
      • Contact: Maria Arcila, MD; Phone Number: 212-639-7879
    • Uniondale, New York, United States, 11553
      • Recruiting
      • Memorial Sloan Kettering Nassau (All protocol activities)
      • Contact: Paola Ghione, MD; Phone Number: 646-608-4263

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ≥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 Criteria:

• 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])

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prospective Group; Study participants with untreated, newly diagnosed follicular lymphoma will have blood collected for cfDNA testing before, during, and after their first-line treatment or observation period	Other: sample of saliva or fingernail clipping; collected in clinic one time; Diagnostic test: pre-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 test: PET/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.; Diagnostic test: cfDNA 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.
Experimental: Retrospective Group; Study participants who have received first-line treatment for follicular lymphoma and are in complete remission will have blood collected for cfDNA testing. In the retrospective cohort, MSKCC patients with CRs lasting ≥10 years after induction therapy will be studied. Initial tumor tissue (if available) will be collected to examine the status of s cfDNA in patients with long-term remissions. Blood samples will be collected once, if the patient has interesting results (e.g. positive cfDNA sample despite CR on imaging, etc.) then additional blood samples may be taken during follow up visits.	Other: sample of saliva or fingernail clipping; collected in clinic one time; Diagnostic test: pre-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 test: PET/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.; Diagnostic test: cfDNA 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
whether the assay can correctly identify presence of disease in patients with measurable disease	Response will be evaluated using the updated response criteria entitled, "The Lugano Classification" system. The investigator will use of the 5-point scale for visually assessing response on the pre- and end-of-treatment FDGPET/CT scans. This scale is commonly referred to as the Deauville criteria; it was developed by international experts in the field at the First International Workshop on interim-PET in Lymphoma in Deauville in 2009 and is routinely applied to patients undergoing lymphoma directed therapy. The 5-point scale is described in the table below. 1 No residual uptake 2 Uptake ≤ mediastinum 3 Uptake > mediastinum but ≤ liver 4 Uptake moderately > liver 5 Markedly increased uptake at any site or progression	2 years

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Paola Ghione, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2020
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: July 9, 2020
• First Posted (Actual): July 13, 2020

Study Record Updates

• Last Update Posted (Actual): August 19, 2025
• Last Update Submitted That Met QC Criteria: August 18, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Cell-free DNA; 20-199
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, Follicular
• Other Study ID Numbers: 20-199

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No