Feasibility and Clinical Utility of Cell-free DNA (cfDNA) in Identifying Actionable Alterations and Minimal Residual Disease for Lymphoma Patients Across Community Centers in Texas

Lymphoma Clinical Trial

Official title:

Feasibility and Clinical Utility of Cell-free DNA (cfDNA) in Identifying Actionable Alterations and Minimal Residual Disease for Lymphoma Patients Across Community Centers in Texas

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05676450
• Other study ID #: 2022-0603
• Secondary ID: NCI-2022-10562
• Status: Recruiting
• Phase: N/A
• Start date: February 23, 2023
• Est. completion date: August 31, 2026

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: Christopher Flowers, MD
• Phone: (713) 745-6095
• Email: crflowers[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To test the feasibility of collecting cell-free DNA (cfDNA) samples from DLBCL patients before and after treatment. cfDNA is DNA traveling in your blood outside of a cell and is easily collected from blood samples drawn using the vein puncture method.

Description:

Primary Objective:

• To determine the feasibility and clinical utility of ctDNA in identifying actionable alterations and minimal residual disease for lymphoma patients across community centers in Texas.

Secondary Objectives:

• To provide useful prognostic information before treatment, assess molecular response at interim time points and residual disease at the end of therapy, and identify tumor-specific mutations

• Levels of cfDNA and its association with both EFS and OS in patients receiving therapy

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 517
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male/female patients who are at least 18 years of age on the day of informed consent signing.

2. Patients must have a histologically documented diffuse large B-cell lymphoma requiring therapy.

3. Provision of written informed consent for the study.

4. Pregnant women not included

5. Cognitively impaired adults are not included.

Exclusion Criteria:

None

Related Conditions & MeSH terms

• Lymphoma
• Neoplasm, Residual

Intervention

Diagnostic Test:
• cell-free DNA
Given by IV (vein)

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas
United States	Cancer Therapy and Research Center at The UT Health Science Center at San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)		through study completion; an average 1 year

External Links

•   MD Anderson Cancer Center