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Clinical Trial NCT04468841 for Follicular Lymphoma is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Memorial Sloan Kettering Cancer CenterMeasuring Cell-Free DNA (cfDNA) Levels in People With Follicular Lymphoma Phase 1 100
Clinical Trial NCT04468841 is designed to study Diagnostic for Follicular Lymphoma. It is a Phase 1 interventional study that is recruiting, having started on 8 July 2020, with plans to enroll 100 participants. Led by Memorial Sloan Kettering Cancer Center, it is expected to complete by 1 July 2026. The latest data from ClinicalTrials.gov was last updated on 19 August 2025.
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 t...Show More
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,...
Show MoreOfficial Title
An Exploratory Study to Correlate the Level of Cell-free DNA With Response to First-line Treatment in Patients With Follicular Lymphoma
Conditions
Follicular LymphomaOther Study IDs
- 20-199
NCT ID Number
Start Date (Actual)
2020-07-08
Last Update Posted
2025-08-19
Completion Date (Estimated)
2026-07
Enrollment (Estimated)
100
Study Type
Interventional
PHASE
Phase 1
Status
Recruiting
Keywords
Cell-free DNA
20-199
20-199
Primary Purpose
Diagnostic
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalProspective 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 | 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. sample of saliva or fingernail clipping collected in clinic one time 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). 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. |
ExperimentalRetrospective 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 col...Show More | 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. sample of saliva or fingernail clipping collected in clinic one time 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). 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. |
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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- ≥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
- Patients receiving second or greater line of therapy (except in retrospective cohort of long-term survivors of FL \[i.e. \>10 years out from frontline treatment\])
Memorial Sloan Kettering Cancer Center739 active studies to exploreStudy Central Contact
Contact: Paola Ghione, MD, 646-608-4263, [email protected]
Contact: Maria Arcila, MD, 212-639-7879
7 Study Locations in 1 Countries
New Jersey
Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, 07920, United States
Paola Ghione, MD, Contact, 646-608-4263
Recruiting
Memorial Sloan Kettering Monmouth (All protocol activities), Middletown, New Jersey, 07748, United States
Paola Ghione, MD, Contact, 646-608-4263
Recruiting
Memorial Sloan Kettering Bergen (All protocol Activities), Montvale, New Jersey, 07645, United States
Paola Ghione, MD, Contact, 646-608-4263
Recruiting
New York
Memorial Sloan Kettering Commack (All Protocol Activities), Commack, New York, 11725, United States
Paola Ghione, MD, Contact, 646-608-4263
Recruiting
Memorial Sloan Kettering Westchester (All Protocol Activities), Harrison, New York, 10604, United States
Paola Ghione, MD, Contact, 646-608-4263
Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, New York, 10065, United States
Paola Ghione, MD, Contact, 646-608-4263
Maria Arcila, MD, Contact, 212-639-7879
Recruiting
Memorial Sloan Kettering Nassau (All Protocol Activities), Uniondale, New York, 11553, United States
Paola Ghione, MD, Contact, 646-608-4263
Recruiting