40 Participants Needed

ctDNA-Guided Therapy for Non-Hodgkin's Lymphoma

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Overseen ByResearch Nurse Navigator
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Hua-Jay J Cherng, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not be on other anti-lymphoma therapies beyond R-CHOP or R-pola-CHP. It's best to discuss your current medications with the trial team to get a clear answer.

What data supports the effectiveness of the treatment PhasED-seq for Non-Hodgkin's Lymphoma?

PhasED-seq has shown improved sensitivity in detecting circulating tumor DNA (ctDNA), which can help identify minimal residual disease in cancers, including B cell lymphomas. In a study, PhasED-seq detected ctDNA in 25% more participants compared to previous methods, indicating its potential to identify patients with worse outcomes earlier.12345

Is ctDNA-Guided Therapy for Non-Hodgkin's Lymphoma safe for humans?

The research articles provided do not contain specific safety data for ctDNA-Guided Therapy or its related methods like PhasED-seq in humans.46789

How does ctDNA-guided therapy differ from other treatments for non-Hodgkin's lymphoma?

ctDNA-guided therapy for non-Hodgkin's lymphoma is unique because it uses circulating tumor DNA (ctDNA) as a 'liquid biopsy' to monitor the disease and guide treatment decisions. This approach allows for non-invasive, real-time tracking of tumor mutations and treatment response, offering a more precise and personalized treatment strategy compared to traditional methods that rely on imaging and tissue biopsies.25101112

What is the purpose of this trial?

The purpose of this study is to 1) determine whether it is feasible to measure circulating tumor DNA (ctDNA) in real-time during standard treatment for newly diagnosed diffuse large B-cell lymphoma (DLBCL), and 2) evaluate the outcomes of participants with undetectable ctDNA in the middle of treatment who receive a shortened course of chemotherapy.There are no investigational drug agents to be administered in this study. The investigational assay, phased variant enrichment and detection sequencing (PhasED-seq) will be used to guide de-escalation of standard-of-care therapy for newly diagnosed DLBCL.The PhasED-seq assay has not yet been approved by the Food and Drug Administration (FDA).

Research Team

HJ

Hua-Jay J Cherng, MD

Principal Investigator

Columbia University

Eligibility Criteria

This trial is for individuals with newly diagnosed diffuse large B-cell lymphoma (DLBCL). Participants will have their circulating tumor DNA (ctDNA) measured during standard chemotherapy to see if a shorter course of treatment can be just as effective.

Inclusion Criteria

Subject/legal representative willing and able to provide written informed consent
Ability to comply with outpatient treatment, laboratory monitoring, and required clinic visits for duration of study participation
My organ and heart functions are good enough for standard cancer treatment.
See 3 more

Exclusion Criteria

My doctor thinks standard treatments won't work well for my condition.
My lymphoma has spread to my brain or spinal cord.
I have had treatment for diffuse large B-cell lymphoma.
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard immunochemotherapy treatment for 4 cycles, with real-time ctDNA sequencing to guide potential de-escalation

4 months
4 cycles of treatment with blood sample collection

De-escalated Treatment

Participants with undetectable ctDNA and complete remission receive rituximab alone for cycles 5 and 6

2 months
2 cycles of rituximab treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

  • Phased Variant Enrichment and Detection Sequencing (PhasED-seq)
Trial Overview The study tests the use of PhasED-seq, an investigational assay not yet FDA-approved, to guide therapy. It aims to determine if patients with undetectable ctDNA midway through treatment can safely receive less chemotherapy than usual.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Group 2Experimental Treatment2 Interventions
All participants on this study will receive standard immunochemotherapy treatment for the first 4 cycles. Blood samples will be collected for real-time ctDNA sequencing with the PhasED-seq assay. Participants with detectable ctDNA, not in in a CR on PET/CT, and/or whose ctDNA sequencing was unsuccessful for any reason will continue standard of care for the remainder of treatment (cycle 5 and 6).
Group II: Group 1Experimental Treatment2 Interventions
All participants on this study will receive standard immunochemotherapy treatment for the first 4 cycles. Blood samples will be collected for real-time ctDNA sequencing with the PhasED-seq assay. Participants with undetectable ctDNA from the first day of cycle 4 and in a complete response (CR) on their PET/CT scan will get de-escalated treatment for cycle 5 and cycle 6 (rituximab alone without chemotherapy)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hua-Jay J Cherng, MD

Lead Sponsor

Trials
1
Recruited
40+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Foresight Diagnostics

Collaborator

Trials
1
Recruited
40+

Conquer Cancer Foundation

Collaborator

Trials
22
Recruited
4,000+

Findings from Research

A new targeted resequencing platform using next-generation sequencing (NGS) has been developed to identify hotspot mutations in lymphoma patients, allowing for sensitive detection of genetic mutations even from limited samples.
This method enhances the ability to assess mutation clone sizes and could lead to more personalized, genotype-specific treatment strategies for lymphoma, addressing the challenges posed by genetic heterogeneity in cancer.
Next-generation sequencing of cancer consensus genes in lymphoma.Hüllein, J., Jethwa, A., Stolz, T., et al.[2019]
PhasED-seq is a new method that significantly improves the sensitivity of detecting circulating tumor-derived DNA (ctDNA), allowing for detection in the parts per million range, which is better than previous methods.
In a study of 213 participants with B cell lymphomas, PhasED-seq identified ctDNA in 25% of patients who were considered ctDNA undetectable by other methods, indicating a potential for worse outcomes and highlighting its importance in monitoring minimal residual disease.
Enhanced detection of minimal residual disease by targeted sequencing of phased variants in circulating tumor DNA.Kurtz, DM., Soo, J., Co Ting Keh, L., et al.[2022]
Monitoring circulating tumor DNA (ctDNA) using next-generation sequencing can detect recurrent lymphoma earlier than traditional imaging scans, allowing for timely intervention.
ctDNA analysis can provide insights into tumor heterogeneity and resistance mechanisms, which can help tailor precision treatments for patients, highlighting the need for standardized collection and processing methods.
Dynamic monitoring of circulating tumor DNA in non-Hodgkin lymphoma.Roschewski, M., Staudt, LM., Wilson, WH.[2021]

References

Next-generation sequencing of cancer consensus genes in lymphoma. [2019]
Enhanced detection of minimal residual disease by targeted sequencing of phased variants in circulating tumor DNA. [2022]
Dynamic monitoring of circulating tumor DNA in non-Hodgkin lymphoma. [2021]
Detection of Rare Mutations in CtDNA Using Next Generation Sequencing. [2019]
Cell-Free DNA for the Management of Classical Hodgkin Lymphoma. [2021]
Advancing NGS quality control to enable measurement of actionable mutations in circulating tumor DNA. [2023]
Sources of erroneous sequences and artifact chimeric reads in next generation sequencing of genomic DNA from formalin-fixed paraffin-embedded samples. [2020]
Evaluation of an integrated clinical workflow for targeted next-generation sequencing of low-quality tumor DNA using a 51-gene enrichment panel. [2019]
Workflow optimization of whole genome amplification and targeted panel sequencing for CTC mutation detection. [2020]
Liquid biopsy in non-Hodgkin's lymphoma. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Molecular Monitoring of Cell-Free Circulating Tumor DNA in Non-Hodgkin Lymphoma. [2018]
Circulating tumor DNA in B-cell lymphoma: technical advances, clinical applications, and perspectives for translational research. [2023]
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