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Prospective ctDNA Testing in Large B-Cell Lymphoma

Recruitingn/aAges 18 Years - anyAllPeking University People's Hospital
NCT07878351 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 s

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📋 Eligibility rules (as published)
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.
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What it tests

  • 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.
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Where

2 sites
Beijing TongRen Hospital
Beijing, China
Peking University People's Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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