Dynamic Monitoring of Plasma ctDNA for Prognostic Assessment in Patients With B-Cell Non-Hodgkin … (NCT07480837) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Dynamic Monitoring of Plasma ctDNA for Prognostic Assessment in Patients With B-Cell Non-Hodgkin Lymphoma
China60 participantsStarted 2026-01-01
Plain-language summary
For patients with newly diagnosed or relapsed/metastatic B-cell non-Hodgkin lymphoma following first-line treatment, peripheral blood samples are collected before treatment and at various treatment time points to monitor circulating tumor DNA (ctDNA), aiming to investigate the correlation between dynamic ctDNA changes and patient prognosis.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Age ≥ 18 years and ≤ 75 years.
* Histopathologically and immunohistochemically confirmed diagnosis of B-cell non-Hodgkin lymphoma (according to the latest WHO classification).
* Presence of at least one evaluable target lesion prior to initial treatment (based on Lugano 2014 criteria).
* Availability of feasible tumor tissue samples or fresh biopsy specimens (from initial diagnosis or relapse biopsy) for establishing a personalized sequencing assay (e.g., identification of patient-specific mutations via tumor tissue DNA sequencing for ctDNA tracking).
* Planned to receive standard regimen therapy (first-line regimen for treatment-naïve patients, second-line regimen for relapsed/refractory patients).
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
* Voluntary participation in this study with written informed consent provided.
Exclusion Criteria:
* Prior treatment with ≥2 lines of systemic anti-lymphoma therapy.
* Presence of other active malignancies
* History of myocardial infarction within the past 1 year; presence of New York Heart Association (NYHA) class III or IV congestive heart failure, or a history of NYHA class III or IV congestive heart failure, unless left ventricular ejection fraction (LVEF) is ≥50% on echocardiography (ECHO) screening performed within 1 month prior to study entry.
* Hepatic or renal dysfunction: creatinine level ≥176.8 μmol/L (2 mg/dL), transaminase or bilirubin levels \>2 × upper limit of nor…
What they're measuring
1
PFS
Timeframe: From enrollment to the end of treatment at 8 weeks
Trial details
NCT IDNCT07480837
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences