Dynamic Monitoring of Plasma ctDNA for Prognostic Assessment in Patients With B-Cell Non-Hodgkin Lymphoma

NCT07480837 | Active Not Recruiting

• 1 other identifier: NCCH0054
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

B-Cell Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• ORR

  From enrollment to the end of treatment at 8 weeks

• OS

  From enrollment to the end of treatment at 8 weeks

• Agreement between ctDNA clearance and PET-CT-defined metabolic complete response (CMR)

  From enrollment to the end of treatment at 8 weeks

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with newly diagnosed or relapsed/metastatic B-cell non-Hodgkin lymphoma following first-line treatment

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

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

Location

Biospecimen

Retention: SAMPLES WITH DNA

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).

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Xinxin Cao, MD

  NCC, CICAMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2026
• First Posted: March 18, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2031
• Last Updated: March 18, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)