NCT07878351|Recruiting
Prospective ctDNA Testing in Large B-Cell Lymphoma
Circulating Tumor DNA Testing in Patients With Large B-Cell Lymphoma: A Prospective Study
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Circulating Tumor DNA Testing in Patients With Large B-Cell Lymphoma: A Prospective Study
Sponsor study identifier
observational
100
1 country
2
Study Start
October 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
August 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) are aggressive lymphomas commonly treated with first-line immunochemotherapy. Some patients experience disease progression or relapse despite treatment. PET/CT is used to assess treatment response, but it may not identify small amounts of residual lymphoma. Circulating tumor DNA (ctDNA) consists of tumor-derived DNA fragments detectable in blood. This prospective observational study will use PhasED-seq to assess plasma ctDNA before, during, and after first-line therapy in approximately 100 patients with newly diagnosed DLBCL or HGBL. The primary objective is to evaluate the association between ctDNA status approximately 8 weeks after completion of first-line therapy and subsequent progression-free survival. Additional analyses will examine overall survival, earlier ctDNA findings, and baseline tumor molecular subtypes. PET/CT findings will provide complementary information for exploratory analyses. The findings may inform future studies of response-adapted treatment.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 5, 2026
Actual (reported)October 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 16, 2026
Actual (reported)August 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Progression-free survival following post-treatment ctDNA assessment
Progression-free survival is defined as the time from the protocol-specified post-treatment ctDNA blood draw, scheduled approximately 8 weeks after completion of first-line therapy, to the first documented disease progression or death from any cause, whichever occurs first. The primary analysis will include patients who are alive and progression-free at this blood draw and have an evaluable ctDNA result. Patients will be classified according to ctDNA status at this same blood draw. Patients without an event will be censored at their last adequate disease assessment or 18 months after the blood draw, whichever occurs first.
From the protocol-specified post-treatment ctDNA blood draw through 18 months after the blood draw.
Overall Survival
From the protocol-specified post-treatment ctDNA blood draw through 18 months after the blood draw.
Correlation between interim ctDNA status and post-treatment progression-free survival
From the date of the post-treatment ctDNA blood draw through 18 months after the blood draw.
Correlation between baseline ctDNA status and post-treatment progression-free survival
From the protocol-specified post-treatment ctDNA blood draw through 18 months after the blood draw.
Correlation between baseline tumor molecular subtype and progression-free survival
From the protocol-specified post-treatment ctDNA blood draw through 18 months after the blood draw.
Adults with previously untreated, histopathologically confirmed DLBCL or HGBL who are planned to receive standard-of-care first-line immunochemotherapy containing an anti-CD20 monoclonal antibody and an anthracycline. Patients will undergo serial plasma ctDNA assessment using PhasED-seq and clinical follow-up.
First-line immunochemotherapy containing an anti-CD20 monoclonal antibody and an anthracycline, such as R-CHOP, Pola-R-CHP, or DA-EPOCH-R. Treatment selection and modification are determined by the treating physician as part of routine clinical care and are not assigned by the study.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Newly diagnosed diffuse large B cell lymphoma (DLBCL), or high-grade B-cell lymphoma (HGBL).
Beijing TongRen Hospital
Beijing, Beijing Municipality, 100041, China
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Peripheral blood samples were collected in Streck tubes. Within 3 days, the sample was separated by centrifugation at 1,600 × g for 10 minutes, and the supernatant was transferred to microcentrifuge tubes, centrifuged again at 16,000 × g for 10 minutes to remove cell debris, and then frozen at -80°C. Circulating cfDNA was extracted of plasma using the QIAamp Circulating Nucleic Acid Kit (Qiagen, Hilden, Germany).
Jin Lu
Peking University People's Hospital
First Submitted
October 5, 2026
First Posted
October 16, 2026
Study Start
October 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
August 31, 2029
A Study of BL-M08D1 in Combination With Immunochemotherapy in Patients With Diffuse Large B-Cell Lymphoma
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 16, 2026
Record last verified: 2026-10
IPD will not be shared due to patient privacy concerns. De-identified aggregate data may be available upon reasonable request with appropriate approvals.
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Source: ClinicalTrials.gov.
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