Clinical trial · Observational
Dynamic Monitoring of Plasma ctDNA for Prognostic Assessment in Patients With B-Cell Non-Hodgkin Lymphoma
Dynamic Monitoring of Plasma Circulating Tumor DNA (ctDNA) for Prognostic Assessment in Patients With B-Cell Non-Hodgkin Lymphoma: An Observational Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-Cell Non-Hodgkin Lymphoma | B-Cell Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- patients with newly diagnosed B-cell non-Hodgkin lymphoma
- description
- Patients with untreated B-cell non-Hodgkin lymphoma
- label
- patients with newly relapsed/metastatic B-cell non-Hodgkin lymphoma
- description
- atients with relapsed or refractory non-Hodgkin B-cell lymphoma who have failed first-line therapy and are candidates for second-line treatment
Primary outcomes (1)
- measure
- PFS
- timeFrame
- From enrollment to the end of treatment at 8 weeks
- description
- PFS defined as the time from the initiation of treatment to disease progression or death from any cause, whichever occurs first.
Secondary outcomes (3)
- measure
- ORR
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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 normal (ULN). * Severe hematologic abnormalities: absolute neutrophil count (ANC) \<1 × 10⁹/L, platelet count \<50 × 10⁹/L. * Presence of uncontrolled infection. * Pregnant or breastfeeding women. * Any other condition that the investigator deems inappropriate for participation in this trial.
References
Publications (0)
Data not yet available