Measuring cell-free DNA levels in patients 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
This study is testing if measuring cell-free DNA in the blood can help understand how well treatment works for people with follicular lymphoma.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT04468841 on ClinicalTrials.gov |
What this trial studies
This study aims to measure and analyze cell-free DNA (cfDNA) in the blood of individuals diagnosed with follicular lymphoma before, during, and after their first-line treatment. Researchers will assess whether cfDNA levels correlate with the patients' responses to standard treatment and explore the relationship between genetic changes in the lymphoma and treatment outcomes. The study involves collecting blood samples at various stages of treatment and comparing cfDNA assay results with traditional response assessment methods like PET-CT scans.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with histologically confirmed follicular lymphoma grade 1-3a who are starting first-line treatment.
Not a fit: Patients who are receiving second or greater lines of therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accurate method for monitoring treatment response in patients with follicular lymphoma.
How similar studies have performed: Other studies have shown promise in using cfDNA as a biomarker for treatment response, indicating that this approach is gaining traction in clinical research.
Eligibility criteria
Show full inclusion / exclusion criteria
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 \[i.e. \>10 years out from frontline treatment\])
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (All protocol activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (All protocol Activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Commack (All Protocol Activities) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (All Protocol Activities) — Uniondale, New York, United States (Recruiting)
Study contacts
- Principal investigator: Paola Ghione, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Paola Ghione, MD
- Email: ghionep@mskcc.org
- Phone: 646-608-4263
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.