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

Primary Purpose

Follicular Lymphoma

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

cfDNA testing

sample of saliva or fingernail clipping

pre-treatment test specimen

PET/CT, CT, or MRI testing

About this trial

This is an interventional diagnostic trial for Follicular Lymphoma focused on measuring Cell-free DNA, 20-199

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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
Sufficient archival tissue available for submission, or planning to undergo a biopsy for SOC that will yield sufficient tissue, (except in the retrospective cohort of long-term survivors of FL [i.e. >10 years out from frontline treatment])

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])

Sites / Locations

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)Recruiting
Memorial Sloan Kettering Monmouth (All protocol activities)Recruiting
Memorial Sloan Kettering Bergen (All protocol Activities)Recruiting
Memorial Sloan Kettering Commack (All Protocol Activities)Recruiting
Memorial Sloan Kettering Westchester (All Protocol Activities)Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
Memorial Sloan Kettering Nassau (All Protocol Activities)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Prospective Group

Retrospective Group

Arm 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

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.

Outcomes

Primary Outcome Measures

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

Response will be evaluated using the updated response criteria entitled, "The Lugano Classification" system. The investigator will use of the 5-point scale for visually assessing response on the pre- and end-of-treatment FDGPET/CT scans. This scale is commonly referred to as the Deauville criteria; it was developed by international experts in the field at the First International Workshop on interim-PET in Lymphoma in Deauville in 2009 and is routinely applied to patients undergoing lymphoma directed therapy. The 5-point scale is described in the table below. 1 No residual uptake 2 Uptake ≤ mediastinum 3 Uptake > mediastinum but ≤ liver 4 Uptake moderately > liver 5 Markedly increased uptake at any site or progression

Secondary Outcome Measures

Full Information

NCT ID

NCT04468841

First Posted

July 9, 2020

Last Updated

March 29, 2023

Sponsor

Memorial Sloan Kettering Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT04468841

Brief Title

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

Official Title

An Exploratory Study to Correlate the Level of Cell-free DNA With Response to First-line Treatment in Patients With Follicular Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 8, 2020 (Actual)

Primary Completion Date

July 2024 (Anticipated)

Study Completion Date

July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Follicular Lymphoma

Keywords

Cell-free DNA, 20-199

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

This is a non-therapeutic protocol. The intervention in this study will involve collection of a standard-of-care pre-treatment tumor biopsy (archival tissue, if available) to identify the tumor-specific s cfDNA signature.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Prospective Group

Arm Type

Experimental

Arm 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

Arm Title

Retrospective Group

Arm Type

Experimental

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

cfDNA testing

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

sample of saliva or fingernail clipping

Intervention Description

collected in clinic one time

Intervention Type

Diagnostic Test

Intervention Name(s)

pre-treatment test specimen

Intervention Description

From bone marrow, blood, lymph node, or alternate site to identify tumor-specific mutations. For retrospective patients initial tumor tissue (if available).

Intervention Type

Diagnostic Test

Intervention Name(s)

PET/CT, CT, or MRI testing

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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])

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Paola Ghione, MD

Phone

646-608-4263

ghionep@mskcc.org

First Name & Middle Initial & Last Name or Official Title & Degree

Maria Arcila, MD

Phone

212-639-7879

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paola Ghione, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

City

Basking Ridge

State/Province

New Jersey

ZIP/Postal Code

07920

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paola Ghione, MD

Phone

646-608-4263

Facility Name

Memorial Sloan Kettering Monmouth (All protocol activities)

City

Middletown

State/Province

New Jersey

ZIP/Postal Code

07748

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paola Ghione, MD

Phone

646-608-4263

Facility Name

Memorial Sloan Kettering Bergen (All protocol Activities)

City

Montvale

State/Province

New Jersey

ZIP/Postal Code

07645

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paola Ghione, MD

Phone

646-608-4263

Facility Name

Memorial Sloan Kettering Commack (All Protocol Activities)

City

Commack

State/Province

New York

ZIP/Postal Code

11725

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paola Ghione, MD

Phone

646-608-4263

Facility Name

Memorial Sloan Kettering Westchester (All Protocol Activities)

City

Harrison

State/Province

New York

ZIP/Postal Code

10604

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paola Ghione, MD

Phone

646-608-4263

Facility Name

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paola Ghione, MD

Phone

646-608-4263

First Name & Middle Initial & Last Name & Degree

Maria Arcila, MD

Phone

212-639-7879

Facility Name

Memorial Sloan Kettering Nassau (All Protocol Activities)

City

Uniondale

State/Province

New York

ZIP/Postal Code

11553

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paola Ghione, MD

Phone

646-608-4263

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Links:

URL

http://www.mskcc.org/mskcc/html/44.cfm

Description

Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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