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

Conditions

• Follicular Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• cfDNA testing — DIAGNOSTIC_TEST
  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.
• sample of saliva or fingernail clipping — OTHER
  collected in clinic one time
• pre-treatment test specimen — DIAGNOSTIC_TEST
  From bone marrow, blood, lymph node, or alternate site to identify tumor-specific mutations. For retrospective patients initial tumor tissue (if available).
• PET/CT, CT, or MRI testing — DIAGNOSTIC_TEST
  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.

Study Details

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.

Key Dates

Start date

Jul 8, 2020

Status verified

Aug 2025

Primary completion

Jul 31, 2026

Completion

Jul 31, 2026

Study Design

Enrollment

100 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Arms

• Experimental: Prospective Group
  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
• Experimental: Retrospective Group
  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.

Primary Outcome Measure

whether the assay can correctly identify presence of disease in patients with measurable disease [ Time Frame: 2 years ]

Central Contacts

• Paola Ghione, MD
  646-608-4263
  [email protected]
• Maria Arcila, MD
  212-639-7879

Locations (7)

Find similar trials in Basking Ridge, NJ

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