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
1 other identifier
interventional
100
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2020
Longer than P75 for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 8, 2020
CompletedFirst Submitted
Initial submission to the registry
July 9, 2020
CompletedFirst Posted
Study publicly available on registry
July 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
August 19, 2025
August 1, 2025
6 years
July 9, 2020
August 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Prospective Group
EXPERIMENTALStudy 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
Retrospective Group
EXPERIMENTALStudy 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.
Interventions
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.
collected in clinic one time
From bone marrow, blood, lymph node, or alternate site to identify tumor-specific mutations. For retrospective patients initial tumor tissue (if available).
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.
Eligibility Criteria
You may qualify if:
- ≥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
You may not qualify if:
- Patients receiving second or greater line of therapy (except in retrospective cohort of long-term survivors of FL \[i.e. \>10 years out from frontline treatment\])
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (All protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Commack (All Protocol Activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paola Ghione, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2020
First Posted
July 13, 2020
Study Start
July 8, 2020
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
August 19, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
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.