Diffuse Large B Cell Lymphoma (DLBCL)NCT07878351
Prospective ctDNA Testing in Large B-Cell Lymphoma
An observational study of Diffuse Large B Cell Lymphoma (DLBCL) and High Grade B Cell Lymphoma, run by Peking University People's Hospital at 2 sites in China.
Trial summary
Diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) are aggressive lymphomas commonly treated with first-line immunochemotherapy. Some patients experience disease progression or relapse despite treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B Cell Lymphoma (DLBCL), High Grade B Cell Lymphoma
- What is being tested?
- Standard-of-care first-line immunochemotherapy containing an anti-CD20 monoclonal antibody and an anthracycline, such as R-CHOP, Pola-R-CHP, or DA-EPOCH-R.
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- 15 Oct 2026to 31 Aug 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Newly diagnosed diffuse large B cell lymphoma (DLBCL), or high-grade B-cell lymphoma (HGBL).
Who may be able to join
- Age ≥18 years, either sex.
- Histopathologically confirmed diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL).
- Planned to receive standard immunochemotherapy including at least CD20 monoclonal antibody and anthracycline, such as Pola-RCHP, R-CHOP, or R-DA-EPOCH.
- No maintenance therapy planned after completion of first-line treatment.
- Written informed consent obtained.
Who cannot join
- DLBCL/HGBL transformed from indolent B-cell lymphoproliferative disorders.
- HIV-positive large B-cell lymphoma.
- Prior chemotherapy, targeted therapy, or immunotherapy for large B-cell lymphoma.
- Investigator-assessed ineligibility for this study.
- Concomitant other malignancies.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Beijing TongRen Hospital
Beijing, Beijing Municipality, 100041
Liang Wang, MD., 010-58268442, wangliangtrhos@126.com
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Yang Liu, MD., 86-13716926210, pkuphliuyang@bjmu.edu.cn
About this study
Official title: Circulating Tumor DNA Testing in Patients With Large B-Cell Lymphoma: A Prospective Study
Diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) are aggressive lymphomas commonly treated with first-line immunochemotherapy. Some patients experience disease progression or relapse despite treatment. PET/CT is used to assess treatment response, but it may not identify small amounts of residual lymphoma.
Circulating tumor DNA (ctDNA) consists of tumor-derived DNA fragments detectable in blood. This prospective observational study will use PhasED-seq to assess plasma ctDNA before, during, and after first-line therapy in approximately 100 patients with newly diagnosed DLBCL or HGBL.
The primary objective is to evaluate the association between ctDNA status approximately 8 weeks after completion of first-line therapy and subsequent progression-free survival. Additional analyses will examine overall survival, earlier ctDNA findings, and baseline tumor molecular subtypes. PET/CT findings will provide complementary information for exploratory analyses. The findings may inform future studies of response-adapted treatment.
Read the detailed description
This is a multicenter, prospective, observational cohort study evaluating the prognostic value of circulating tumor DNA (ctDNA), measured using PhasED-seq, in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL). Approximately 100 patients will be enrolled. The primary objective is to assess the association between post-treatment ctDNA status and subsequent progression-free survival (PFS).
Patients will undergo baseline PET/CT imaging and tumor tissue next-generation sequencing (NGS). First-line immunochemotherapy will be selected and managed by the treating physician according to routine clinical practice and will not be assigned by the study. Interim PET/CT assessment is planned after 3 cycles of treatment, and post-treatment PET/CT is planned approximately 8 weeks after completion of first-line therapy. Plasma samples for PhasED-seq ctDNA analysis will be collected before initiation of first-line therapy, after 3 cycles of treatment, and approximately 8 weeks after completion of first-line therapy, within the protocol-specified sampling windows.
The primary analysis will include patients who are alive and progression-free at the protocol-specified post-treatment ctDNA blood draw and have an evaluable ctDNA result. Patients will be classified as ctDNA-positive or ctDNA-negative according to the result from this blood draw. PFS will be measured from this blood draw to the first documented disease progression or death from any cause, whichever occurs first, with a primary observation period of 18 months.
Additional analyses will evaluate overall survival and the associations of interim ctDNA status, baseline ctDNA status, and baseline tumor molecular subtype with post-treatment PFS. These analyses will use the primary analysis population, restricted as necessary to patients with evaluable results for the marker being investigated. Associations involving earlier biomarkers will therefore describe subsequent outcomes among patients who remain alive and progression-free at the post-treatment assessment. PET/CT findings will be examined alongside ctDNA findings in exploratory analyses.
Patients who discontinue or change first-line treatment will remain in the enrolled cohort. Subsequent treatment and clinical outcomes will continue to be recorded where consent permits. Inclusion in each analysis population and the handling of missing or unevaluable results will follow prespecified criteria in the study protocol and statistical analysis plan. An unevaluable ctDNA result will not be classified as ctDNA-negative.
- Being tested
- Standard-of-care first-line immunochemotherapy containing an anti-CD20 monoclonal antibody and an anthracycline, such as R-CHOP, Pola-R-CHP, or DA-EPOCH-R.
- Keywords
- Circulating tumor DNA, Diffuse Large B cell Lymphoma, High Grade B Cell Lymphoma
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard-of-care first-line immunochemotherapy containing an anti-CD20 monoclonal antibody and an anthracycline, such as R-CHOP, Pola-R-CHP, or DA-EPOCH-R.Drug
First-line immunochemotherapy containing an anti-CD20 monoclonal antibody and an anthracycline, such as R-CHOP, Pola-R-CHP, or DA-EPOCH-R. Treatment selection and modification are determined by the treating physician as part of routine clinical care and are not assigned by the study.
| Study group | Role | What they receive |
|---|---|---|
| Newly diagnosed DLBCL or HGBL | Adults with previously untreated, histopathologically confirmed DLBCL or HGBL who are planned to receive standard-of-care first-line immunochemotherapy containing an anti-CD20 monoclonal antibody and an anthracycline. Patients will undergo serial plasma ctDNA assessment using PhasED-seq and clinical follow-up. Receives: Drug: Standard-of-care first-line immunochemotherapy containing an anti-CD20 monoclonal antibody and an anthracycline, such as R-CHOP, Pola-R-CHP, or DA-EPOCH-R. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival following post-treatment ctDNA assessment
Progression-free survival is defined as the time from the protocol-specified post-treatment ctDNA blood draw, scheduled approximately 8 weeks after completion of first-line therapy, to the first documented disease progression or death from any cause, whichever occurs first. The primary analysis will include patients who are alive and progression-free at this blood draw and have an evaluable ctDNA result. Patients will be classified according to ctDNA status at this same blood draw. Patients without an event will be censored at their last adequate disease assessment or 18 months after the blood draw, whichever occurs first.
Measured: From the protocol-specified post-treatment ctDNA blood draw through 18 months after the blood draw.
Secondary outcomes (2)
Overall Survival
Overall survival is defined as the time from the protocol-specified post-treatment ctDNA blood draw to death from any cause. OS will be compared according to ctDNA status at this blood draw. Patients who remain alive will be censored at the last date they are known to be alive or 18 months after the blood draw, whichever occurs first.
Measured: From the protocol-specified post-treatment ctDNA blood draw through 18 months after the blood draw.
Correlation between interim ctDNA status and post-treatment progression-free survival
The association between ctDNA status at interim assessment after 3 cycles of first-line therapy and post-treatment PFS will be evaluated among patients included in the primary analysis population. PFS will be defined as specified for the primary outcome.
Measured: From the date of the post-treatment ctDNA blood draw through 18 months after the blood draw.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell Lymphoma (DLBCL)Studies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Lu, MD, Peking University People's Hospital
- Investigators
- Jin Lu, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878351
- Sponsor's protocol ID
- 2026PHB541-001
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to patient privacy concerns. De-identified aggregate data may be available upon reasonable request with appropriate approvals.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor DNA Testing in Patients With Large B-Cell Lymphoma: A Prospective Study
- ClinicalTrials.gov ID
- NCT07878351
- Acronym / sponsor ID
- 2026PHB541-001
- Keywords
- Circulating tumor DNA, Diffuse Large B cell Lymphoma, High Grade B Cell Lymphoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 16 Oct 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.
Diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) are aggressive lymphomas commonly treated with first-line immunochemotherapy. Some patients experience disease progression or relapse despite treatment. PET/CT is used to assess treatment response, but it may not identify small amounts of residual lymphoma.
Circulating tumor DNA (ctDNA) consists of tumor-derived DNA fragments detectable in blood. This prospective observational study will use PhasED-seq to assess plasma ctDNA before, during, and after first-line therapy in approximately 100 patients with newly diagnosed DLBCL or HGBL.
The primary objective is to evaluate the association between ctDNA status approximately 8 weeks after completion of first-line therapy and subsequent progression-free survival. Additional analyses will examine overall survival, earlier ctDNA findings, and baseline tumor molecular subtypes. PET/CT findings will provide complementary information for exploratory analyses. The findings may inform future studies of response-adapted treatment.
Detailed description
This is a multicenter, prospective, observational cohort study evaluating the prognostic value of circulating tumor DNA (ctDNA), measured using PhasED-seq, in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL). Approximately 100 patients will be enrolled. The primary objective is to assess the association between post-treatment ctDNA status and subsequent progression-free survival (PFS).
Patients will undergo baseline PET/CT imaging and tumor tissue next-generation sequencing (NGS). First-line immunochemotherapy will be selected and managed by the treating physician according to routine clinical practice and will not be assigned by the study. Interim PET/CT assessment is planned after 3 cycles of treatment, and post-treatment PET/CT is planned approximately 8 weeks after completion of first-line therapy. Plasma samples for PhasED-seq ctDNA analysis will be collected before initiation of first-line therapy, after 3 cycles of treatment, and approximately 8 weeks after completion of first-line therapy, within the protocol-specified sampling windows.
The primary analysis will include patients who are alive and progression-free at the protocol-specified post-treatment ctDNA blood draw and have an evaluable ctDNA result. Patients will be classified as ctDNA-positive or ctDNA-negative according to the result from this blood draw. PFS will be measured from this blood draw to the first documented disease progression or death from any cause, whichever occurs first, with a primary observation period of 18 months.
Additional analyses will evaluate overall survival and the associations of interim ctDNA status, baseline ctDNA status, and baseline tumor molecular subtype with post-treatment PFS. These analyses will use the primary analysis population, restricted as necessary to patients with evaluable results for the marker being investigated. Associations involving earlier biomarkers will therefore describe subsequent outcomes among patients who remain alive and progression-free at the post-treatment assessment. PET/CT findings will be examined alongside ctDNA findings in exploratory analyses.
Patients who discontinue or change first-line treatment will remain in the enrolled cohort. Subsequent treatment and clinical outcomes will continue to be recorded where consent permits. Inclusion in each analysis population and the handling of missing or unevaluable results will follow prespecified criteria in the study protocol and statistical analysis plan. An unevaluable ctDNA result will not be classified as ctDNA-negative.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newly diagnosed DLBCL or HGBL | – | Drug: Standard-of-care first-line immunochemotherapy containing an anti-CD20 monoclonal antibody and an anthracycline, such as R-CHOP, Pola-R-CHP, or DA-EPOCH-R.Adults with previously untreated, histopathologically confirmed DLBCL or HGBL who are planned to receive standard-of-care first-line immunochemotherapy containing an anti-CD20 monoclonal antibody and an anthracycline. Patients will undergo serial plasma ctDNA assessment using PhasED-seq and clinical follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed diffuse large B cell lymphoma (DLBCL), or high-grade B-cell lymphoma (HGBL).
Key inclusion criteria (5 listed)
- Age ≥18 years, either sex.
- Histopathologically confirmed diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL).
- Planned to receive standard immunochemotherapy including at least CD20 monoclonal antibody and anthracycline, such as Pola-RCHP, R-CHOP, or R-DA-EPOCH.
- No maintenance therapy planned after completion of first-line treatment.
- Written informed consent obtained.
Key exclusion criteria (5 listed)
- DLBCL/HGBL transformed from indolent B-cell lymphoproliferative disorders.
- HIV-positive large B-cell lymphoma.
- Prior chemotherapy, targeted therapy, or immunotherapy for large B-cell lymphoma.
- Investigator-assessed ineligibility for this study.
- Concomitant other malignancies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard-of-care first-line immunochemotherapy containing an anti-CD20 monoclonal antibody and an anthracycline, such as R-CHOP, Pola-R-CHP, or DA-EPOCH-R.First-line immunochemotherapy containing an anti-CD20 monoclonal antibody and an anthracycline, such as R-CHOP, Pola-R-CHP, or DA-EPOCH-R. Treatment selection and modification are determined by the treating physician as part of routine clinical care and are not assigned by the study. | Drug | Newly diagnosed DLBCL or HGBL |
Primary outcome
Progression-free survival following post-treatment ctDNA assessment
Time frame: From the protocol-specified post-treatment ctDNA blood draw through 18 months after the blood draw.
Progression-free survival is defined as the time from the protocol-specified post-treatment ctDNA blood draw, scheduled approximately 8 weeks after completion of first-line therapy, to the first documented disease progression or death from any cause, whichever occurs first. The primary analysis will include patients who are alive and progression-free at this blood draw and have an evaluable ctDNA result. Patients will be classified according to ctDNA status at this same blood draw. Patients without an event will be censored at their last adequate disease assessment or 18 months after the blood draw, whichever occurs first.
2 secondary outcomes
Overall Survival
Time frame: From the protocol-specified post-treatment ctDNA blood draw through 18 months after the blood draw.
Correlation between interim ctDNA status and post-treatment progression-free survival
Time frame: From the date of the post-treatment ctDNA blood draw through 18 months after the blood draw.
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 16 Oct 2026.
- Individual participant dataSharing planned: No. IPD will not be shared due to patient privacy concerns. De-identified aggregate data may be available upon reasonable request with appropriate approvals.
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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.
Jin Lu principal investigator
Peking University People's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diffuse Large B Cell Lymphoma (DLBCL) and High Grade B Cell Lymphoma, run by Peking University People's Hospital at 2 sites 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Jin Lu, MD. (86-13716926210, lujin@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival following post-treatment ctDNA assessment (time frame: From the protocol-specified post-treatment ctDNA blood draw through 18 months after the blood draw.). 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 16 Oct 2026.