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cfDNA Testing for Follicular Lymphoma

Phase 1

Recruiting

Led By Gottfried von Keudell, MD, PhD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histology-confirmed follicular lymphoma grade 1-3a, verified by the enrolling institution

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is measuring and testing cell-free DNA in the blood before, during, and after treatment for follicular lymphoma to see if it's related to treatment response and to understand how different genetic changes in follicular lymphoma relate to response to treatment.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Since this trial involves diagnostic procedures like PET/CT, CT, MRI testing, saliva or fingernail sampling rather than new treatments, typical side effects associated with medications aren't expected. However, there may be minimal risks related to discomfort or reactions from imaging tests.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My lymphoma is confirmed as grade 1-3a follicular type.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

whether the assay can correctly identify presence of disease in patients with measurable disease

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

0 / 1Eligibility criteria met