An Exploratory Study to Correlate the Level of Cell-free DNA With Response to First-line Treatment in Patients With Follicular Lymphoma
Memorial Sloan Kettering Cancer Center
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.
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.…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 yea…
Interventions
- Diagnostic TestcfDNA 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.
- Othersample of saliva or fingernail clipping
collected in clinic one time
- Diagnostic Testpre-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 TestPET/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.
Locations (7)
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities)Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (All protocol activities)Middletown, New Jersey
- Memorial Sloan Kettering Bergen (All protocol Activities)Montvale, New Jersey
- Memorial Sloan Kettering Commack (All Protocol Activities)Commack, New York
- Memorial Sloan Kettering Westchester (All Protocol Activities)Harrison, New York
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)New York, New York