B-Cell Non-Hodgkin LymphomaNCT07480837
Dynamic Monitoring of Plasma ctDNA for Prognostic Assessment in Patients With B-Cell Non-Hodgkin Lymphoma
An observational study of B-Cell Non-Hodgkin Lymphoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- B-Cell Non-Hodgkin Lymphoma
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 1 Jan 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with newly diagnosed or relapsed/metastatic B-cell non-Hodgkin lymphoma following first-line treatment
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
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
About this study
Official title: Dynamic Monitoring of Plasma Circulating Tumor DNA (ctDNA) for Prognostic Assessment in Patients With B-Cell Non-Hodgkin Lymphoma: An Observational Study
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.
Read the detailed description
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).
- Conditions
- B-Cell Non-Hodgkin Lymphoma
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
PFS defined as the time from the initiation of treatment to disease progression or death from any cause, whichever occurs first.
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (3)
ORR
The overall response rate (ORR) was defined as the cumulative proportion of patients attaining either a complete response (CR) or partial response (PR) .
Measured: From enrollment to the end of treatment at 8 weeks
OS
OS was measured from treatment initiation to death from any causea
Measured: 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.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start1 Jan 2026
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-Cell Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xinxin Cao, MD, Principal investigator, NCC, CICAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480837
- Sponsor's protocol ID
- NCCH0054
- Status last verified
- Jan 2026
- First submitted
- 14 Mar 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Monitoring of Plasma Circulating Tumor DNA (ctDNA) for Prognostic Assessment in Patients With B-Cell Non-Hodgkin Lymphoma: An Observational Study
- ClinicalTrials.gov ID
- NCT07480837
- Acronym / sponsor ID
- NCCH0054
- Conditions
- B-Cell Non-Hodgkin Lymphoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2031 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with newly diagnosed or relapsed/metastatic B-cell non-Hodgkin lymphoma following first-line treatment
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PFS
Time frame: From enrollment to the end of treatment at 8 weeks
PFS defined as the time from the initiation of treatment to disease progression or death from any cause, whichever occurs first.
3 secondary outcomes
ORR
Time frame: From enrollment to the end of treatment at 8 weeks
OS
Time frame: From enrollment to the end of treatment at 8 weeks
Agreement between ctDNA clearance and PET-CT-defined metabolic complete response (CMR)
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xinxin Cao, MD principal investigator
NCC, CICAMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of B-Cell Non-Hodgkin Lymphoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: From enrollment to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.