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

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Lymphoma

Treatments: Diagnostic Test: cell-free DNA

Study type: Interventional

Funder types: Other

Identifiers

NCT05676450

NCI-2022-10562 (Other Identifier)

2022-0603

Details and patient eligibility

About

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.

Full 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

Enrollment: 517 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

517 participants in 1 patient group

cell-free DNA (cfDNA) samples

Other group

Description:

cell-free DNA (cfDNA) samples from DLBCL participants 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. Blood will be drawn 3 times (by vein)

Treatment:

Diagnostic Test: cell-free DNA