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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,826 Total Patients Enrolled

Gottfried von Keudell, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

1 Previous Clinical Trials

6 Total Patients Enrolled

Connie Batlevi, MD, PhD, MSPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

1 Previous Clinical Trials

32 Total Patients Enrolled

Media Library

cfDNA testing Clinical Trial Eligibility Overview. Trial Name: NCT04468841 — Phase 1

Follicular Lymphoma Research Study Groups: Retrospective Group, Prospective Group

Follicular Lymphoma Clinical Trial 2023: cfDNA testing Highlights & Side Effects. Trial Name: NCT04468841 — Phase 1

cfDNA testing 2023 Treatment Timeline for Medical Study. Trial Name: NCT04468841 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the present capacity for enrolment in this clinical trial?

"Affirmative. Per the information presented on clinicaltrials.gov, recruitment for this medical experiment is ongoing. This trial was first posted in July of 2020 and recently revised at the commencement of October 2022; it seeks to recruit 100 participants from 9 locations."

Answered by AI

How many healthcare centers are running this experiment?

"This research venture is currently underway at 9 medical centres, situated in Middletown, Montvale and Harrison alongside other urban settings. To minimize travel requirements for participants, it's best to choose the closest clinic when enrolling."

Answered by AI

Are there any unreserved slots for participants in this research?

"The clinical trial, which was initially uploaded on July 8th 2020, is actively recruiting participants. Updated information can be found on clinicaltrials.gov as of October 3rd 2022."

Answered by AI

Does the Food and Drug Administration recognize cfDNA testing as a valid medical practice?

"According to the experts at Power, cfDNA testing ranks a 1 on the safety scale due it being in its initial stage of development, with limited data available for both efficacy and safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "Measuring Cell-Free DNA (cfDNA) Levels in People With Follicular Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04468841.

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