ctDNA-Guided Therapy for Non-Hodgkin's Lymphoma
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?
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive standard immunochemotherapy treatment for 4 cycles, with real-time ctDNA sequencing to guide potential de-escalation
De-escalated Treatment
Participants with undetectable ctDNA and complete remission receive rituximab alone for cycles 5 and 6
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Phased Variant Enrichment and Detection Sequencing (PhasED-seq)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hua-Jay J Cherng, MD
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Foresight Diagnostics
Collaborator
Conquer Cancer Foundation
Collaborator