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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with newly diagnosed B-cell non-Hodgkin lymphoma | Patients with untreated B-cell non-Hodgkin lymphoma | ||
| patients with newly relapsed/metastatic B-cell non-Hodgkin lymphoma | atients with relapsed or refractory non-Hodgkin B-cell lymphoma who have failed first-line therapy and are candidates for second-line treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| PFS | PFS defined as the time from the initiation of treatment to disease progression or death from any cause, whichever occurs first. | From enrollment to the end of treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | The overall response rate (ORR) was defined as the cumulative proportion of patients attaining either a complete response (CR) or partial response (PR) . | From enrollment to the end of treatment at 8 weeks |
| OS |
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Inclusion Criteria:
Exclusion Criteria:
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patients with newly diagnosed or relapsed/metastatic B-cell non-Hodgkin lymphoma following first-line treatment
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| Name | Affiliation | Role |
|---|---|---|
| Xinxin Cao, MD | NCC, CICAMS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
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| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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For each patient, blood samples were collected before treatment, during the middle stage of treatment, and after the completion of treatment. Approximately 10 mL of peripheral blood is collected each time, and the total volume is controlled within a safe range (a total of 60-80 mL over 3-4 collections).
OS was measured from treatment initiation to death from any causea
| 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. | From enrollment to the end of treatment at 8 weeks |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |