cfDNA Testing for Follicular Lymphoma
Recruiting in Palo Alto (17 mi)
+8 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Memorial Sloan Kettering Cancer Center
Disqualifiers: Second-line therapy, others
No Placebo Group
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?
How does cfDNA testing differ from other treatments for follicular lymphoma?
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
I am 18 or older and can give my consent, or someone legally allowed can on my behalf.
Ability to adhere to the study visit schedule and all the protocol requirements
Measurable FDG-avid disease
See 2 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.
Trial 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 (Biomarker)
Trial OverviewThe 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
Research Locations NearbySelect from list below to view details:
Memoral Sloan Kettering Basking Ridge (All Protocol Activities)Basking Ridge, NJ
Memoral Sloan Kettering Monmouth (All protocol activities)Middletown, NJ
Memorial Sloan Kettering Commack (All Protocol Activities)Commack, NY
Memorial Sloan Kettering Westchester (All Protocol Activities)Harrison, NY
More Trial Locations
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Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Trials
1998
Patients Recruited
602,000+
Findings from Research
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Cell-free DNA and the monitoring of lymphoma treatment.Camus, V., Jardin, F.[2020]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
[Quantitation of Circulating Cell-free DNA in Patients with Lymphoma and Its Clinical Significance].Chen, YY., Guo, SQ., Li, YH., et al.[2018]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
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]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Treatment of Non-Small-Cell Lung Cancer Based on Circulating Cell-Free DNA and Impact of Variation Allele Frequency.Bustamante Alvarez, JG., Janse, S., Owen, DH., et al.[2022]
A study of 101 laboratories revealed that most circulating tumor DNA (cfDNA) testing is conducted by commercial and international labs, which tend to have higher test volumes and larger gene panels compared to hospital-based labs.
The findings indicate that while both next-generation sequencing (NGS) and non-NGS methods are used to analyze key cancer-related genes, laboratories using FDA-approved non-NGS assays for EGFR show higher analytical sensitivities, suggesting a potential advantage in accuracy for specific tests.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Clinical Testing for Tumor Cell-Free DNA: College of American Pathologists Proficiency Programs Reveal Practice Trends.Devereaux, KA., Souers, RJ., Merker, JD., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Mutation Profiling of Malignant Lymphoma by Next-Generation Sequencing of Circulating Cell-Free DNA.Sun, P., Chen, C., Xia, Y., et al.[2020]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Clinical Practice Guidelines for Pre-Analytical Procedures of Plasma Epidermal Growth Factor Receptor Variant Testing.Shin, S., Woo, HI., Kim, JW., et al.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
The analysis of cell-free DNA concentrations and integrity in serum of initial and treated of lymphoma patients.Wu, J., Tang, W., Huang, L., et al.[2019]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Decisional regret in women receiving high risk or inconclusive prenatal cell-free DNA screening results.Gammon, BL., Jaramillo, C., Riggan, KA., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Cell-Free DNA for the Management of Classical Hodgkin Lymphoma.Camus, V., Jardin, F.[2021]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Application of circulating tumour DNA in terms of prognosis prediction in Chinese follicular lymphoma patients.Zhao, M., Li, Q., Yang, J., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Integration of molecular testing for the personalized management of patients with diffuse large B-cell lymphoma and follicular lymphoma.Stuckey, R., Luzardo Henríquez, H., de la Nuez Melian, H., et al.[2023]
NCBI (Pubmed)
pubmed.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.Fernández-Miranda, I., Pedrosa, L., Llanos, M., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
The role of circulating free DNA in the management of NSCLC.Esposito Abate, R., Pasquale, R., Fenizia, F., et al.[2019]
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]
Integration of molecular testing for the personalized management of patients with diffuse large B-cell lymphoma and follicular lymphoma. [2023]
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]