Cell-free DNA Testing for Lymphoma

Recruiting at 1 trial location

Overseen By Chijioke Nze, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Cognitive impairment

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

517 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if collecting cell-free DNA (cfDNA)—DNA that circulates in the blood outside of cells—is feasible for individuals with diffuse large B-cell lymphoma (DLBCL). Researchers will collect cfDNA samples from patients before and after treatment using standard blood draws from a vein. This trial targets individuals diagnosed with DLBCL who are about to begin therapy. As an unphased trial, it offers a unique opportunity to advance research in DLBCL diagnostics.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this method is safe for collecting cell-free DNA?

Research has shown that cell-free DNA (cfDNA) testing is safe. cfDNA refers to DNA that floats in the blood outside of cells. Collecting cfDNA is noninvasive and involves taking a blood sample, similar to a regular blood test.

Studies indicate that cfDNA can help doctors assess treatment effectiveness for people with lymphoma. Various studies have used this testing, and patients generally tolerate it well. No major reports of problems have arisen from the simple blood draw required for this test.

Overall, cfDNA testing is considered safe and is already used to gather important health information without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about cell-free DNA (cfDNA) testing for lymphoma because it offers a non-invasive method to monitor the disease. Unlike traditional biopsies, which require tissue samples from the lymph nodes or other affected areas, cfDNA testing uses blood samples to detect DNA fragments that tumors shed into the bloodstream. This approach could make it easier and less painful for patients to undergo regular monitoring. Additionally, cfDNA testing has the potential to provide real-time insights into how well a treatment is working, helping doctors adjust treatment plans more quickly and effectively.

What evidence suggests that cell-free DNA testing is effective for lymphoma?

Research shows that cell-free DNA (cfDNA) is a promising tool for monitoring lymphoma, a type of blood cancer. In this trial, researchers will collect cfDNA samples from participants with large B-cell lymphomas before and after treatment. cfDNA can reveal genetic information from tumor cells without invasive procedures. Studies have shown that cfDNA can track treatment effectiveness in lymphoma patients. This is particularly useful for patients with large B-cell lymphomas, where residual disease can worsen the cancer. Additionally, higher cfDNA levels have been linked to a greater cancer burden, potentially identifying those with more severe disease. Overall, cfDNA offers a non-invasive method to monitor and possibly predict treatment outcomes in lymphoma. ^{1 2 5 6 7}

Who Is on the Research Team?

Chijioke Nze, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with diffuse large B-cell lymphoma (DLBCL) needing treatment. Participants must be able to give written consent and should not be pregnant or cognitively impaired. The study aims to include a diverse group from community centers across Texas.

Inclusion Criteria

Pregnant women not included

Provision of written informed consent for the study

Cognitively impaired adults are not included

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment

Collection of cell-free DNA (cfDNA) samples from participants before treatment

1 week

1 visit (in-person)

Treatment

Participants receive therapy, and cfDNA samples are collected to assess molecular response and residual disease

12 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with cfDNA samples collected to identify tumor-specific mutations

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• cell-free DNA

Trial Overview The trial is exploring the use of cell-free DNA (cfDNA) as a tool to detect genetic changes in DLBCL patients and monitor minimal residual disease after treatment. cfDNA samples are taken from blood drawn through vein puncture before and after therapy.

How Is the Trial Designed?

Group I: cell-free DNA (cfDNA) samples Experimental Treatment 1 Intervention

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)

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

Circulating tumor-derived DNA (ctDNA) testing is a promising method for identifying tumor-specific genetic changes through blood tests, which can help guide targeted therapies and monitor treatment response in lymphoma patients.

High levels of ctDNA before treatment are associated with more advanced disease and poorer prognosis, and monitoring ctDNA during therapy may predict clinical outcomes, although standardization and further evaluation are needed for routine clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential of Circulating Tumor DNA for the Management of Patients With Lymphoma. Huet, S., Salles, G.[2021]

Circulating tumor DNA (ctDNA) is a promising biomarker for lymphoid malignancies, allowing for a comprehensive molecular profile of tumors without the need for invasive tissue biopsies, which is particularly useful for tumors in hard-to-reach areas.

Monitoring ctDNA levels can provide real-time insights into tumor dynamics and treatment effectiveness, with early reductions in ctDNA correlating with better clinical outcomes, making it a potential tool for detecting minimal residual disease and early relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Circulating tumour DNA in B-cell lymphomas: current state and future prospects. Lakhotia, R., Roschewski, M.[2021]

Circulating tumor DNA (ctDNA) is a promising minimally invasive method for detecting and monitoring various lymphoma subtypes, providing critical information on genotyping, treatment response, and predicting relapse.

ctDNA can detect minimal residual disease even when traditional imaging shows no signs of cancer, highlighting its potential as a powerful biomarker for improving diagnosis and treatment outcomes in lymphoma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Circulating Tumor DNA in Lymphoma. Thiruvengadam, SK., Zain, J.[2023]

Plasma cell-free DNA (cfDNA) provides a non-invasive method to profile tumor DNA in lymphoma patients, serving as a valuable alternative to traditional tissue biopsies for genotyping.

cfDNA analysis can be used for multiple purposes, including identifying tumor mutations without a biopsy, tracking changes in tumor genetics that may lead to treatment resistance, and monitoring residual disease after therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methods for Measuring ctDNA in Lymphomas. Rossi, D., Condoluci, A., Spina, V., et al.[2019]

Circulating tumor DNA (ctDNA) profiling offers a noninvasive method for monitoring B-cell lymphoma, providing real-time insights into the tumor's genetic makeup and allowing for better disease management compared to traditional tissue biopsies.

ctDNA assessment can enhance lymphoma subtype classification, treatment response evaluation, and monitoring of residual disease, making it a promising tool for personalized treatment strategies and potential use in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Circulating tumor DNA in B-cell lymphoma: technical advances, clinical applications, and perspectives for translational research. Lauer, EM., Mutter, J., Scherer, F.[2023]

Circulating cell-free DNA (CFDNA) levels are significantly higher in lymphoma patients compared to those with lymphadenitis and healthy individuals, suggesting that CFDNA quantification could be a valuable screening tool for lymphoma.

A higher clearance rate of circulating CFDNA after standard therapy is associated with better treatment outcomes, including higher complete remission rates and longer overall survival, indicating its potential as a prognostic indicator.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Quantitation of Circulating Cell-free DNA in Patients with Lymphoma and Its Clinical Significance]. Chen, YY., Guo, SQ., Li, YH., et al.[2018]

Cell-free DNA (cfDNA) levels in plasma are significantly higher in lymphoma patients at initial diagnosis compared to those in the treated stage, and also higher than in healthy controls, indicating its potential as a biomarker for lymphoma.

cfDNA concentration correlates with important clinical parameters such as ECOG score and LDH levels, and shows better sensitivity and specificity for diagnosing lymphoma compared to traditional LDH testing, suggesting it could be a valuable tool for monitoring treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The analysis of cell-free DNA concentrations and integrity in serum of initial and treated of lymphoma patients. Wu, J., Tang, W., Huang, L., et al.[2019]

Circulating tumor DNA (ctDNA) assessment has shown promise in diagnosing and monitoring various lymphoma subtypes, including diffuse large B-cell lymphoma and Hodgkin lymphoma, indicating its potential as a valuable tool in lymphoma management.

Recent advances in ctDNA applications include developing new prognostic models and assessing treatment response, suggesting that ctDNA could enhance personalized medicine approaches in lymphoma, although further studies are needed for clinical validation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Updates on Circulating Tumor DNA Assessment in Lymphoma. Darrah, JM., Herrera, AF.[2019]

Cell-free DNA (cfDNA) analysis, or liquid biopsy, is a promising noninvasive method for monitoring minimal residual disease in lymphomas, offering advantages like ease of blood sample collection and rapid results.

This technique allows for real-time monitoring of treatment responses and can quickly detect treatment resistance, making it a significant advancement in the management of lymphoma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cell-free DNA and the monitoring of lymphoma treatment. Camus, V., Jardin, F.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9245363/

Circulating Tumor DNA in Lymphoma: Principles and Future ... ctDNA is an emerging biomarker for lymphomas that noninvasively provides genotypic information and can measure the effectiveness of treatment.

2. jhoonline.biomedcentral.com jhoonline.biomedcentral.com/articles/10.1186/s13045-025-01673-7

Circulating tumor DNA in lymphoma: technologies and ... Circulating cell-free DNA (cfDNA) refers to small fragments of DNA, typically ∼ 70–200 base pairs in length, that are released into the ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO-25-01534

Remission Assessment by Circulating Tumor DNA in Large ... PURPOSELarge B-cell lymphomas (LBCLs) are curable, but patients with residual disease after therapy invariably experience progression.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497123126838

Circulating Cell-Free DNA (ccfDNA) Concentrations ... We observed positive associations between ccfDNA [ ] in diagnostic samples of DLBCL patients and biomarkers of high tumor burden, including higher LDH levels (p ...

5. ashpublications.org ashpublications.org/bloodadvances/article/9/17/4528/537382/Circulating-tumor-DNA-determinants-of-response-and

Circulating tumor DNA determinants of response and outcome ... Multiple dimensions of ctDNA expose heterogeneity in R/R MCL to predict response and outcome. Longitudinal ctDNA assessment by duplex sequencing complements ...

6. nature.com nature.com/articles/s41375-022-01618-w

Circulating tumor DNA in B-cell lymphoma Cell-free DNA and circulating tumor DNA are released from malignant and non-malignant tissue into the blood stream and cerebrospinal fluid, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6614089/

Clinical significance of cell-free DNA as a prognostic ... The investigation of plasma concentration of cfDNA may reveal its use as a valuable biomarker for risk stratification of diffuse large B-cell lymphoma (DLBCL).