ctDNA testing in newly diagnosed DLBCL or HGBL to predict treatment outcomes
Official title: Circulating Tumor DNA Testing in Patients With Large B-Cell Lymphoma: A Prospective Study
Run by Peking University People's Hospital · NCT07878351 · Data updated 2026-11-12
This study checks if measuring circulating tumor DNA in blood after first-line therapy can predict whether the disease will stay away or come back in people with DLBCL or HGBL.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Peking University People's Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Status | Recruiting |
| Started | October 15, 2026 |
| Main results expected | August 31, 2029 |
| Study ends | August 31, 2029 |
| Registry record updated | October 16, 2026 |
| Trial ID | NCT07878351 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with newly diagnosed DLBCL or HGBL planned for standard first-line immunochemotherapy including CD20 antibody and an anthracycline.
✕Probably not a fit
Patients whose disease biology does not shed detectable ctDNA or whose outcomes are not correlated with ctDNA status may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter prospective observational study evaluates whether post-treatment ctDNA status, measured with PhasED-seq, is associated with progression-free survival in adults with newly diagnosed DLBCL or HGBL receiving standard immunochemotherapy. Blood samples are collected before treatment, after three cycles, and about eight weeks after completing therapy. Baseline PET/CT and tumor tissue sequencing are performed, with interim and end-of-treatment PET/CT used for exploratory analyses. No treatment is assigned by the study; treatment decisions follow routine clinical practice. Primary analysis focuses on patients who are alive and progression-free at the post-treatment ctDNA time point and have evaluable ctDNA results.
Why it matters
Potential benefit: If ctDNA after treatment reliably predicts outcomes, clinicians could tailor follow-up and additional therapies more precisely.
How similar studies have gone: prior studies in other lymphomas suggest ctDNA can reflect disease burden and prognosis, supporting this approach's potential.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years, either sex. * Histopathologically confirmed diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL). * Planned to receive standard immunochemotherapy including at least CD20 monoclonal antibody and anthracycline, such as Pola-RCHP, R-CHOP, or R-DA-EPOCH. * No maintenance therapy planned after completion of first-line treatment. * Written informed consent obtained. Exclusion Criteria: * DLBCL/HGBL transformed from indolent B-cell lymphoproliferative disorders. * HIV-positive large B-cell lymphoma. * Prior chemotherapy, targeted therapy, or immunotherapy for large B-cell lymphoma. * Investigator-assessed ineligibility for this study. * Concomitant other malignancies.
Where it's running
-
Beijing TongRen Hospital
Beijing, Beijing Municipality, China Recruiting -
Peking University People's Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Principal investigator: Jin Lu — Peking University People's Hospital
- Study coordinator: Jin Lu, MD.
- Email: lujin@pku.edu.cn
- Phone: 86-13716926210
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.