100 Participants Needed

cfDNA Testing for Follicular Lymphoma

Recruiting at 8 trial locations
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MA
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PG
Overseen ByPaola Ghione, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on measuring cfDNA in relation to the usual first-line treatment for follicular lymphoma.

What data supports the effectiveness of the treatment cfDNA for Follicular Lymphoma?

Research shows that analyzing cell-free DNA (cfDNA) can help in diagnosing and predicting the progression of follicular lymphoma by identifying specific genetic mutations linked to the disease. This method is non-invasive and can provide important information about the cancer's behavior, potentially guiding treatment decisions.12345

Is cfDNA testing safe for humans?

cfDNA testing is generally considered safe as it involves a noninvasive blood test, which is simple and has a fast turnover time. It has been used in various conditions, including lymphomas and prenatal screenings, without significant safety concerns reported.678910

How does cfDNA testing differ from other treatments for follicular lymphoma?

cfDNA testing for follicular lymphoma is unique because it uses a blood test to analyze DNA fragments from tumors, providing a non-invasive way to monitor the disease and predict treatment response, unlike traditional methods that rely on tissue biopsies.311121314

Research Team

PG

Paola Ghione, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults over 18 with confirmed grade 1-3a follicular lymphoma who can follow the study schedule and requirements. They must have measurable disease that shows up on scans and either have enough tissue from previous biopsies or are planning a biopsy. People already receiving second-line therapy cannot join, except those in long-term survival after first-line treatment.

Inclusion Criteria

Ability to adhere to the study visit schedule and all the protocol requirements
Measurable FDG-avid disease
I have enough stored tissue for testing or will have a biopsy to provide it.
See 1 more

Exclusion Criteria

I am receiving my second or later treatment for my condition, except if I've survived follicular lymphoma for over 10 years since my first treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive first-line treatment for follicular lymphoma, with cfDNA levels measured before, during, and after treatment

6-8 cycles
Visits at the start, after 2 cycles, and at the completion of 6-8 cycles

Follow-up

Participants are monitored for cfDNA levels every 6 months for a total of 2 years from the initiation of therapy

2 years
Every 6 months

Radiation Therapy Follow-up

For patients receiving RT, cfDNA levels are measured before RT and at 3, 6, 12, 18, and 24 months post RT

24 months
Visits at 3, 6, 12, 18, and 24 months post RT

Treatment Details

Interventions

  • cfDNA
Trial Overview The study measures cell-free DNA (cfDNA) levels in blood at different times during standard first-line treatment for follicular lymphoma to see if cfDNA relates to how well patients respond. It also examines genetic changes in the cancer cells and their impact on treatment response.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Retrospective GroupExperimental Treatment4 Interventions
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.
Group II: Prospective GroupExperimental Treatment4 Interventions
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Findings from Research

Cell-free DNA (cfDNA) analysis, or liquid biopsy, is a promising noninvasive method for monitoring minimal residual disease in lymphomas, offering advantages like ease of blood sample collection and rapid results.
This technique allows for real-time monitoring of treatment responses and can quickly detect treatment resistance, making it a significant advancement in the management of lymphoma patients.
Cell-free DNA and the monitoring of lymphoma treatment.Camus, V., Jardin, F.[2020]
Circulating cell-free DNA (CFDNA) levels are significantly higher in lymphoma patients compared to those with lymphadenitis and healthy individuals, suggesting that CFDNA quantification could be a valuable screening tool for lymphoma.
A higher clearance rate of circulating CFDNA after standard therapy is associated with better treatment outcomes, including higher complete remission rates and longer overall survival, indicating its potential as a prognostic indicator.
[Quantitation of Circulating Cell-free DNA in Patients with Lymphoma and Its Clinical Significance].Chen, YY., Guo, SQ., Li, YH., et al.[2018]
This study evaluated 20 treatment-naive follicular lymphoma (FL) patients and found that higher concentrations of circulating cell-free DNA (cfDNA) and specific somatic mutations in cfDNA were associated with poorer survival outcomes, indicating cfDNA's potential as a prognostic tool.
The presence of BCL2 mutations in cfDNA improved the ability to predict patient outcomes and could guide targeted therapies, suggesting that cfDNA analysis may enhance diagnosis and risk stratification in FL patients.
Plasma Concentrations and Cancer-Associated Mutations in Cell-Free Circulating DNA of Treatment-Naive Follicular Lymphoma for Improved Non-Invasive Diagnosis and Prognosis.Hatipoğlu, T., Esmeray Sönmez, E., Hu, X., et al.[2022]

References

Cell-free DNA and the monitoring of lymphoma treatment. [2020]
[Quantitation of Circulating Cell-free DNA in Patients with Lymphoma and Its Clinical Significance]. [2018]
Plasma Concentrations and Cancer-Associated Mutations in Cell-Free Circulating DNA of Treatment-Naive Follicular Lymphoma for Improved Non-Invasive Diagnosis and Prognosis. [2022]
Treatment of Non-Small-Cell Lung Cancer Based on Circulating Cell-Free DNA and Impact of Variation Allele Frequency. [2022]
Clinical Testing for Tumor Cell-Free DNA: College of American Pathologists Proficiency Programs Reveal Practice Trends. [2023]
Mutation Profiling of Malignant Lymphoma by Next-Generation Sequencing of Circulating Cell-Free DNA. [2020]
Clinical Practice Guidelines for Pre-Analytical Procedures of Plasma Epidermal Growth Factor Receptor Variant Testing. [2022]
The analysis of cell-free DNA concentrations and integrity in serum of initial and treated of lymphoma patients. [2019]
Decisional regret in women receiving high risk or inconclusive prenatal cell-free DNA screening results. [2023]
Cell-Free DNA for the Management of Classical Hodgkin Lymphoma. [2021]
Application of circulating tumour DNA in terms of prognosis prediction in Chinese follicular lymphoma patients. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Integration of molecular testing for the personalized management of patients with diffuse large B-cell lymphoma and follicular lymphoma. [2023]
13.United Statespubmed.ncbi.nlm.nih.gov
Monitoring of Circulating Tumor DNA Predicts Response to Treatment and Early Progression in Follicular Lymphoma: Results of a Prospective Pilot Study. [2023]
The role of circulating free DNA in the management of NSCLC. [2019]
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