An observational study in Diffuse Large B Cell Lymphoma (DLBCL) and High Grade B Cell Lymphoma, sponsored by Peking University People's Hospital. Recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Peking University People's Hospital · Observational
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.
This is a multicenter, prospective, observational cohort study evaluating the prognostic value of circulating tumor DNA (ctDNA), measured using PhasED-seq, in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL). Approximately 100 patients will be enrolled. The primary objective is to assess the association between post-treatment ctDNA status and subsequent progression-free survival (PFS).
Patients will undergo baseline PET/CT imaging and tumor tissue next-generation sequencing (NGS). First-line immunochemotherapy will be selected and managed by the treating physician according to routine clinical practice and will not be assigned by the study. Interim PET/CT assessment is planned after 3 cycles of treatment, and post-treatment PET/CT is planned approximately 8 weeks after completion of first-line therapy. Plasma samples for PhasED-seq ctDNA analysis will be collected before initiation of first-line therapy, after 3 cycles of treatment, and approximately 8 weeks after completion of first-line therapy, within the protocol-specified sampling windows.
The primary analysis will include patients who are alive and progression-free at the protocol-specified post-treatment ctDNA blood draw and have an evaluable ctDNA result. Patients will be classified as ctDNA-positive or ctDNA-negative according to the result from this blood draw. PFS will be measured from this blood draw to the first documented disease progression or death from any cause, whichever occurs first, with a primary observation period of 18 months.
Additional analyses will evaluate overall survival and the associations of interim ctDNA status, baseline ctDNA status, and baseline tumor molecular subtype with post-treatment PFS. These analyses will use the primary analysis population, restricted as necessary to patients with evaluable results for the marker being investigated. Associations involving earlier biomarkers will therefore describe subsequent outcomes among patients who remain alive and progression-free at the post-treatment assessment. PET/CT findings will be examined alongside ctDNA findings in exploratory analyses.
Patients who discontinue or change first-line treatment will remain in the enrolled cohort. Subsequent treatment and clinical outcomes will continue to be recorded where consent permits. Inclusion in each analysis population and the handling of missing or unevaluable results will follow prespecified criteria in the study protocol and statistical analysis plan. An unevaluable ctDNA result will not be classified as ctDNA-negative.
1,432 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 359 are open to participants now.
This study's planned enrollment of 100 is below the median of 154 across 156 observational studies indexed under Lymphoma, Large B-Cell, Diffuse.
Browse Lymphoma, Large B-Cell, Diffuse studies →Peking University People's Hospital is the lead sponsor of 603 studies on the registry; 241 are open to participants now.
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Newly diagnosed diffuse large B cell lymphoma (DLBCL), or high-grade B-cell lymphoma (HGBL).
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Exclusion Criteria:
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.
Drug: Standard-of-care first-line immunochemotherapy containing an anti-CD20 monoclonal antibody and an anthracycline, such as R-CHOP, Pola-R-CHP, or DA-EPOCH-R.
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.
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.
Time frame: From the protocol-specified post-treatment ctDNA blood draw through 18 months after the blood draw.
Overall Survival
Overall survival is defined as the time from the protocol-specified post-treatment ctDNA blood draw to death from any cause. OS will be compared according to ctDNA status at this blood draw. Patients who remain alive will be censored at the last date they are known to be alive or 18 months after the blood draw, whichever occurs first.
Time frame: 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
The association between ctDNA status at interim assessment after 3 cycles of first-line therapy and post-treatment PFS will be evaluated among patients included in the primary analysis population. PFS will be defined as specified for the primary outcome.
Time frame: 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
The association between baseline ctDNA status and post-treatment PFS will be evaluated among patients included in the primary analysis population. PFS will be defined as specified for the primary outcome.
Time frame: 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
The association between baseline tumor molecular subtype, determined using a prespecified classification method based on tissue NGS, and PFS following the protocol-specified post-treatment ctDNA blood draw will be evaluated. PFS will be defined as specified for the primary outcome.
Time frame: From the protocol-specified post-treatment ctDNA blood draw through 18 months after the blood draw.
Plan to share: No — 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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