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.
This study is a prospective, observational, single-center clinical research aimed at exploring the correlation between the dynamic changes of plasma circulating tumor DNA (ctDNA) before and after treatment and the prognosis of patients with B-cell non-Hodgkin's lymphoma (B-NHL). A total of 60 patients who were initially treated with evaluable target lesions and were capable of undergoing molecular pathological testing, either in the initial treatment stage or after relapse/refractory treatment, were planned to be included. All patients will provide peripheral blood samples for ctDNA testing at the pre-treatment stage, during the mid-treatment stage, and after the end of treatment. Simultaneously, standard efficacy assessment PET-CT examinations will be conducted. The primary endpoint of the study is progression-free survival (PFS), while the secondary endpoints include overall response rate (ORR), overall survival (OS), and the consistency analysis between ctDNA clearance rate and PET-CT metabolic complete response (CMR).
Study Type
OBSERVATIONAL
Enrollment
60
Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
PFS
PFS defined as the time from the initiation of treatment to disease progression or death from any cause, whichever occurs first.
Time frame: From enrollment to the end of treatment at 8 weeks
ORR
The overall response rate (ORR) was defined as the cumulative proportion of patients attaining either a complete response (CR) or partial response (PR) .
Time frame: From enrollment to the end of treatment at 8 weeks
OS
OS was measured from treatment initiation to death from any causea
Time frame: From enrollment to the end of treatment at 8 weeks
Agreement between ctDNA clearance and PET-CT-defined metabolic complete response (CMR)
This term refers to the concordance between two indicators of treatment response in lymphoma: the undetectable status of circulating tumor DNA in peripheral blood (ctDNA clearance) and the absence of pathological fluorodeoxyglucose (FDG) uptake on PET-CT imaging (metabolic complete remission). High agreement suggests that liquid biopsy may serve as a non-invasive surrogate for radiographic remission assessment.
Time frame: From enrollment to the end of treatment at 8 weeks
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