Lymphoma, Large B-Cell, DiffuseNCT06289959
Plasma cfDNA Testing Guiding the Treatment Decisions of DLBCL
A study testing cfDNA in people with Lymphoma, Large B-Cell, Diffuse, run by Second Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
A prospective, single center, randomized, clinical controlled study to evaluate the efficacy and prognosis differences between precision treatment based on plasma cfDNA testing results and the current conventional diagnostic and treatment practices for DLBCL patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Large B-Cell, Diffuse
- What is being tested?
- cfDNA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 25 Feb 2024to 1 Jan 2029
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥ 18 years, gender not specified.
- Newly diagnosed patients with diffuse large B-cell lymphoma (DLBCL) confirmed by histopathological examination. Patients should test positive for plasma cfDNA before treatment (defined as positive for point mutations, CNV, IgH-related fusion, or IG clonal rearrangement) and achieve complete metabolic remission after 6 cycles of R-CHOP chemotherapy (evaluated by Lugano response assessment criteria).
- Patients for whom the researcher predicts a life expectancy of >6 months.
- Signed informed consent form.
Who cannot join
- Patients who have undergone autologous stem cell transplantation.
- Patients with a history of other malignant tumors, except for basal cell carcinoma of the skin or in situ cervical cancer.
- Patients with uncontrolled cardiovascular diseases, coagulation disorders, connective tissue diseases, severe infectious diseases, and other such conditions;
- Primary central nervous system lymphoma.
- Patients with mental illness or others known or suspected to be unable to fully comply with the study protocol.
- Pregnant or lactating women.
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- HbsAg-positive patients who need to undergo HBV-DNA testing and can only be included if they seroconvert. Additionally, if the HbsAg test is negative but the HBcAb test is positive (regardless of HbsAb status), HBV-DNA testing is also required. If the result is positive, inclusion is possible only after seroconversion.
- HIV-infected individuals.
- Other concurrent and uncontrolled diseases that researchers believe may affect the medical condition of patients participating in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Bingzong Li, Professor, 0086-13776054037, lbzwz0907@hotmail.com
About this study
Official title: A Prospective, Single-Center, Randomized, Controlled Study Guiding the Treatment of Diffuse Large B-Cell Lymphoma Patients Based on Plasma cfDNA Testing
A prospective, single center, randomized, clinical controlled study to evaluate the efficacy and prognosis differences between precision treatment based on plasma cfDNA testing results and the current conventional diagnostic and treatment practices for DLBCL patients.
Read the detailed description
This study is initiated by researchers and is a prospective, single-center, randomized, clinical controlled study. The study subjects are newly diagnosed DLBCL patients with plasma cfDNA positivity (defined as positive for point mutations, CNV, IgH-related fusion, or IG clonal rearrangement). After achieving complete metabolic remission (Lugano response assessment criteria) following 6 cycles of R-CHOP-like chemotherapy, patients undergo plasma cfDNA testing upon enrollment. Plasma cfDNA-negative patients (Group 1) continue to receive monotherapy with rituximab for 2 cycles, while plasma cfDNA-positive patients are randomly assigned to Group 2 and Group 3. Group 2 patients continue monotherapy with rituximab for 2 cycles, and Group 3 patients receive the original regimen for 2 cycles. Plasma cfDNA testing is performed again for all three groups after completion of the entire treatment. Patient progression-free survival (PFS) is observed for 2 years. After treatment completion, follow-up visits are scheduled every 3 months for a total of 24 months.
Research Objective: Evaluate the efficacy and prognosis differences between precision treatment based on plasma cfDNA testing results and the current conventional diagnostic and treatment practices for DLBCL patients.
Expected Results: Determining subsequent treatment based on plasma cfDNA MRD results at the end of DLBCL patient treatment is expected to aid in identifying high-risk patients for early relapse and improving their prognosis.
- Conditions
- Lymphoma, Large B-Cell, Diffuse
- Being tested
- cfDNA
- Keywords
- cfDNA, therapy
- 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.
cfDNADiagnostic test
After achieving complete metabolic remission (Lugano response assessment criteria) following 6 cycles of R-CHOP-like chemotherapy, patients undergo plasma cfDNA testing upon enrollment，and the follow-up treatment plans are based on cfDNA results.
| Study group | Role | What they receive |
|---|---|---|
| Group1（Plasma cfDNA-negative patients） | Active comparator | Continue to receive monotherapy with rituximab （375mg/m2 q3w）for 2 cycles Receives: Diagnostic Test: cfDNA |
| Group2（plasma cfDNA-positive patients） | Experimental | Continue monotherapy with rituximab （375mg/m2 q3w）for 2 cycles Receives: Diagnostic Test: cfDNA |
| Group3（plasma cfDNA-positive patients） | Experimental | Receive the original regimen for 2 cycles（R-CHOP like） Receives: Diagnostic Test: cfDNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival（PFS）
Evaluate the PFS among three groups with different treatment practices for diffuse large B-cell lymphoma (DLBCL) patients.
Measured: From date of randomization until the date of first documented progression or date of death from any cause,whichever came first，assessed up to 24 months.
Secondary outcomes (2)
Sensitivity, and specificity of plasma cfDNA in DLBCL patients
Evaluate the sensitivity, and specificity of plasma cfDNA testing at the end of treatment in DLBCL
Measured: From date of randomization until the date of first documented progression or date of death from any cause,whichever came first，assessed up to 24 months.
Overall survivals(OS)
overall survival in DLBCL patients.
Measured: From date of randomization until the date of first documented progression or date of death from any cause,whichever came first，assessed up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start25 Feb 2024 (estimated)
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Large B-Cell, DiffuseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bingzong Li, Professor, Study chair, Second Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289959
- Sponsor's protocol ID
- JD-LC2023006-I01
- Status last verified
- Mar 2024
- First submitted
- 25 Jan 2024
- Last updated
- 4 Mar 2024
- 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 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Center, Randomized, Controlled Study Guiding the Treatment of Diffuse Large B-Cell Lymphoma Patients Based on Plasma cfDNA Testing
- ClinicalTrials.gov ID
- NCT06289959
- Acronym / sponsor ID
- JD-LC2023006-I01
- Conditions
- Lymphoma, Large B-Cell, Diffuse
- Keywords
- cfDNA, therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 25 Feb 2024 (estimated)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 4 Mar 2024 (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.
A prospective, single center, randomized, clinical controlled study to evaluate the efficacy and prognosis differences between precision treatment based on plasma cfDNA testing results and the current conventional diagnostic and treatment practices for DLBCL patients.
Detailed description
This study is initiated by researchers and is a prospective, single-center, randomized, clinical controlled study. The study subjects are newly diagnosed DLBCL patients with plasma cfDNA positivity (defined as positive for point mutations, CNV, IgH-related fusion, or IG clonal rearrangement). After achieving complete metabolic remission (Lugano response assessment criteria) following 6 cycles of R-CHOP-like chemotherapy, patients undergo plasma cfDNA testing upon enrollment. Plasma cfDNA-negative patients (Group 1) continue to receive monotherapy with rituximab for 2 cycles, while plasma cfDNA-positive patients are randomly assigned to Group 2 and Group 3. Group 2 patients continue monotherapy with rituximab for 2 cycles, and Group 3 patients receive the original regimen for 2 cycles. Plasma cfDNA testing is performed again for all three groups after completion of the entire treatment. Patient progression-free survival (PFS) is observed for 2 years. After treatment completion, follow-up visits are scheduled every 3 months for a total of 24 months.
Research Objective: Evaluate the efficacy and prognosis differences between precision treatment based on plasma cfDNA testing results and the current conventional diagnostic and treatment practices for DLBCL patients.
Expected Results: Determining subsequent treatment based on plasma cfDNA MRD results at the end of DLBCL patient treatment is expected to aid in identifying high-risk patients for early relapse and improving their prognosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group1（Plasma cfDNA-negative patients） | Active comparator | Diagnostic Test: cfDNAContinue to receive monotherapy with rituximab （375mg/m2 q3w）for 2 cycles |
| Group2（plasma cfDNA-positive patients） | Experimental | Diagnostic Test: cfDNAContinue monotherapy with rituximab （375mg/m2 q3w）for 2 cycles |
| Group3（plasma cfDNA-positive patients） | Experimental | Diagnostic Test: cfDNAReceive the original regimen for 2 cycles（R-CHOP like） |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years, gender not specified.
- Newly diagnosed patients with diffuse large B-cell lymphoma (DLBCL) confirmed by histopathological examination. Patients should test positive for plasma cfDNA before treatment (defined as positive for point mutations, CNV, IgH-related fusion, or IG clonal rearrangement) and achieve complete metabolic remission after 6 cycles of R-CHOP chemotherapy (evaluated by Lugano response assessment criteria).
- Patients for whom the researcher predicts a life expectancy of >6 months.
- Signed informed consent form.
Key exclusion criteria (9 listed)
- Patients who have undergone autologous stem cell transplantation.
- Patients with a history of other malignant tumors, except for basal cell carcinoma of the skin or in situ cervical cancer.
- Patients with uncontrolled cardiovascular diseases, coagulation disorders, connective tissue diseases, severe infectious diseases, and other such conditions;
- Primary central nervous system lymphoma.
- Patients with mental illness or others known or suspected to be unable to fully comply with the study protocol.
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 |
|---|---|---|
| cfDNAAfter achieving complete metabolic remission (Lugano response assessment criteria) following 6 cycles of R-CHOP-like chemotherapy, patients undergo plasma cfDNA testing upon enrollment，and the follow-up treatment plans are based on cfDNA results. | Diagnostic test | Group1（Plasma cfDNA-negative patients）, Group2（plasma cfDNA-positive patients）, Group3（plasma cfDNA-positive patients） |
Primary outcome
Progression-free survival（PFS）
Time frame: From date of randomization until the date of first documented progression or date of death from any cause,whichever came first，assessed up to 24 months.
Evaluate the PFS among three groups with different treatment practices for diffuse large B-cell lymphoma (DLBCL) patients.
2 secondary outcomes
Sensitivity, and specificity of plasma cfDNA in DLBCL patients
Time frame: From date of randomization until the date of first documented progression or date of death from any cause,whichever came first，assessed up to 24 months.
Overall survivals(OS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause,whichever came first，assessed up to 24 months.
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 4 Mar 2024.
- 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.
Bingzong Li, Professor study chair
Second Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cfDNA in people with Lymphoma, Large B-Cell, Diffuse, run by Second Affiliated Hospital of Soochow University 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 4 inclusion and 9 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: opening soon, as of the sponsor's last update on 4 Mar 2024. 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?
Contact Han Zhang, Master (0086-13914064082, 805294554@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival（PFS） (time frame: From date of randomization until the date of first documented progression or date of death from any cause,whichever came first，assessed up to 24 months.). 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 4 Mar 2024.