Measuring Cell-Free DNA (cfDNA) Levels in People With Follicular Lymphoma

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Enrolling; Phase 1

Conditions: Follicular Lymphoma

Treatments: Diagnostic Test: PET/CT, CT, or MRI testing; Diagnostic Test: pre-treatment test specimen; Other: sample of saliva or fingernail clipping; Diagnostic Test: cfDNA testing

Study type: Interventional

Funder types: Other

Identifiers

NCT04468841

20-199

Details and patient eligibility

About

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.

Full 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. For patients who receive RT, peripheral blood samples will be collected before initiation of RT, and then 3 months, 6 months, 12 months, 18 months and 24 months post RT using a s cfDNA assay.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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])

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Prospective Group

Experimental group

Description:

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

Treatment:

Diagnostic Test: cfDNA testing

Other: sample of saliva or fingernail clipping

Diagnostic Test: pre-treatment test specimen

Diagnostic Test: PET/CT, CT, or MRI testing

Retrospective Group

Experimental group

Description:

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.

Treatment:

Diagnostic Test: cfDNA testing

Other: sample of saliva or fingernail clipping

Diagnostic Test: pre-treatment test specimen

Diagnostic Test: PET/CT, CT, or MRI testing