Cell-free DNA Testing for Lymphoma

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Christopher Flowers, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Cognitive impairment

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial involves collecting DNA from blood samples of DLBCL patients to monitor their cancer and treatment response. By analyzing this DNA, doctors can identify changes in the cancer and check if any cancer cells remain after treatment.

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 data supports the effectiveness of the treatment cell-free DNA testing for lymphoma?

Research shows that cell-free DNA testing, also known as liquid biopsy, is effective in monitoring lymphoma treatment. It allows for noninvasive tracking of tumor changes and helps in adjusting treatment in real-time, similar to its successful use in acute leukemias. ^{1 2 3 4 5}

Is cell-free DNA testing safe for humans?

Cell-free DNA testing, including circulating tumor DNA (ctDNA), is considered safe as it is a minimally invasive method that uses blood samples to detect tumor DNA, avoiding the need for more invasive tissue biopsies. ^{5 6 7 8 9}

How is cell-free DNA testing unique for treating lymphoma?

Cell-free DNA testing for lymphoma is unique because it allows for the detection and monitoring of tumor DNA in the blood without needing a tissue biopsy. This method can identify tumor mutations, track changes in the tumor over time, and monitor the effectiveness of treatment, making it a less invasive and potentially more comprehensive approach compared to traditional methods. ^{1 3 4 5 8}

Research Team

Christopher Flowers, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

I am 18 years old or older.

Provision of written informed consent for the study

Exclusion Criteria

Not applicable.

Trial Timeline

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)

Treatment Details

Interventions

• cell-free DNA (Diagnostic Test)

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.

Participant Groups

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+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

Findings from Research

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) 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]

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]

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-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) 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]

References

1. China pubmed.ncbi.nlm.nih.gov

[Quantitation of Circulating Cell-free DNA in Patients with Lymphoma and Its Clinical Significance]. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Cell-free DNA and the monitoring of lymphoma treatment. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Updates on Circulating Tumor DNA Assessment in Lymphoma. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

The analysis of cell-free DNA concentrations and integrity in serum of initial and treated of lymphoma patients. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Methods for Measuring ctDNA in Lymphomas. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Potential of Circulating Tumor DNA for the Management of Patients With Lymphoma. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Circulating tumour DNA in B-cell lymphomas: current state and future prospects. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Circulating Tumor DNA in Lymphoma. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Circulating tumor DNA in B-cell lymphoma: technical advances, clinical applications, and perspectives for translational research. [2023]