Diffuse Large B-Cell Lymphoma (DLBCL)Phase 2NCT07917624
Prophylactic Strategies for Mitigating Central Nervous System Relapse in Diffuse Large B-Cell Lymphoma
A Phase 2 study testing Lenalidomide, Bruton's tyrosine kinase inhibitor and Chidamide in people with Diffuse Large B-Cell Lymphoma (DLBCL), run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
Background: The central nervous system (CNS) recurrence rate of patients with high-risk diffuse large B-cell lymphoma (DLBCL) is as high as 15% - 20%, and the prognosis is extremely poor once it occurs. Current intrathecal injection and high-dose methotrexate prophylaxis are ineffective and have significant toxicity. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma (DLBCL)
- What is being tested?
- Lenalidomide, Bruton's tyrosine kinase inhibitor and Chidamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2026to 1 Nov 2028
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. The diagnosis of diffuse large B-cell lymphoma, non-specific type or indolent lymphoma that has undergone large B-cell transformation, has been confirmed by histopathological examination; according to the 2016/2022 WHO classification, advanced B-cell lymphoma with dual expression/dual therapy is allowed; 2. Age between 18 and 80 years; 3. Proposed or currently receiving first-line standard immunotherapy, and planning to complete at least 6 cycles; 4. Baseline examination including brain-enhanced MR and cerebrospinal fluid cytology/flow cytometry by lumbar puncture was conducted to rule out CNS invasion; 5. Has at least one high-risk factor for CNS recurrence: CNS-IPI score ≥ 4 points; or involving specific extranodal sites (such as testis, breast, adrenal gland, kidney, uterus, bone marrow, high-risk bones); or extranodal invasion sites ≥ 2; 6. ECOG physical status score 0-2; 7. The subject can understand the study protocol and is willing to participate in this study, and signs a written informed consent.
Who cannot join
- 1. Any evidence indicating the presence of CNS parenchymal, meningeal or intraocular lymphoma at the time of enrollment; 2. Having a history of myocardial infarction within 6 months prior to enrollment; suffering from New York Heart Association (NYHA) grade 3 or 4 congestive heart failure, or having a history of NYHA grade 3 or 4 congestive heart failure in the past, unless the left ventricular ejection fraction (LVEF) was ≥ 50% in the echocardiography (ECHO) screening conducted within 1 month before entering the study; 3. Pregnant or lactating women (baseline pregnancy test positive or not undergoing pregnancy test for women of childbearing age. Postmenopausal women must be at least 12 months post-menopause); 4. Having an uncontrollable infection; 5. Any other situation that the investigator deems the patient is not suitable to participate in this trial.
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
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
XinXin XX Cao, doctor, +86-18618315968, caoxinxin@126.com
About this study
Official title: Therapeutic Strategies for Preventing Central Nervous System Recurrence in Patients With Central High-risk Diffuse Large B-cell Lymphoma: A Prospective, Multicenter, Non-randomized Cohort Study
Background: The central nervous system (CNS) recurrence rate of patients with high-risk diffuse large B-cell lymphoma (DLBCL) is as high as 15% - 20%, and the prognosis is extremely poor once it occurs. Current intrathecal injection and high-dose methotrexate prophylaxis are ineffective and have significant toxicity. Lenalidomide, BTK inhibitors, and sidaribine all can penetrate the blood-brain barrier, and each has shown a signal of reducing the risk of CNS recurrence in previous studies, but there is still a lack of prospective concurrent comparative data.
Objective: To preliminarily evaluate the efficacy and safety of using these three oral drugs (lenalidomide, BTK inhibitors, and sidaribine) in combination with first-line immunotherapy chemotherapy for high-risk DLBCL patients to prevent CNS recurrence during the same period or after chemotherapy.
Read more
Method: This study is a phase II exploratory, open-label, non-randomized concurrent multi-cohort study, combined with historical external controls. A total of 87 patients with DLBCL diagnosed by histopathology and having at least one CNS high-risk factor (CNS-IPI ≥ 4 points, specific extranodal involvement (such as testis, breast, adrenal gland, kidney, uterus, bone marrow, bone), and extranodal invasion sites ≥ 2) are planned to be enrolled. Patients can choose to enter the lenalidomide group, BTK inhibitor group (ibrutinib, zanubrutinib, or obinutinib) or sidaribine group based on their disease characteristics and economic conditions, and the preventive treatment lasts for 1 year. The primary endpoint is the 2-year cumulative CNS recurrence rate (competitive risk model analysis), and the secondary endpoints include progression-free survival time, overall survival time, CNS disease-free survival time, and safety.
Significance: This study is the first to prospectively compare the CNS preventive value of these three drugs with different mechanisms in high-risk DLBCL patients, which is expected to provide key exploratory data for this field and lay the foundation for future confirmatory studies.
- Conditions
- Diffuse Large B-Cell Lymphoma (DLBCL)
- Being tested
- Lenalidomide, Bruton's tyrosine kinase inhibitor, Chidamide
- 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.
LenalidomideDrug
The dosage of lenalidomide is 25mg each time, once daily, taken with food or on an empty stomach. It is administered continuously from day 1 to day 21, with each 28-day period as one cycle. For elderly patients (aged > 75 years) or those with reduced renal function (creatinine clearance rate < 60 ml/min), the starting dose is reduced to 15mg. During the lenalidomide treatment, aspirin 100mg once daily or low molecular weight heparin is used to prevent thrombosis. The preventive drugs can be initiated simultaneously with chemotherapy or started 4-6 weeks after the completion of chemotherapy for continuous prevention, which is determined by the investigator. After the chemotherapy, it enters the single-agent maintenance stage, with the total prevention medication duration of 1 year (counting from the first administration), or until disease progression, intolerable toxicity occurs, or informed consent is withdrawn.
Bruton's tyrosine kinase inhibitorDrug
The BTK inhibitor group includes drugs such as Zanubrutinib, Obinutinib, and Ibrutinib. Their specific usage is as follows: Zanubrutinib, 160mg each time, taken twice daily before or after meals; Ibrutinib, 560mg each time, once daily, taken before or after meals; Obinutinib, 150mg each time, once daily, taken before or after meals. Preventive drugs can be initiated simultaneously with chemotherapy or started 4-6 weeks after the completion of chemotherapy, depending on the decision of the researchers. After the completion of chemotherapy, it enters the single-agent maintenance stage. The total preventive medication duration is 1 year (counting from the first administration), or until disease progression, intolerable toxicity occurs, or informed consent is withdrawn.
ChidamideDrug
Chidamide is administered at a dose of 20mg every 21 days. The medication is taken on days 1, 4, 8, and 11 of each cycle, 30 minutes after meals. The preventive medication can be initiated simultaneously with chemotherapy or started 4-6 weeks after the completion of chemotherapy, depending on the decision of the investigator. After the chemotherapy is completed, it enters the single-agent maintenance phase. The total preventive medication duration is 1 year (counting from the first administration), or until disease progression, intolerable toxicity occurs, or informed consent is withdrawn.
| Study group | Role | What they receive |
|---|---|---|
| Patients with diffuse large B-cell lymphoma who meet the criteria for high-risk central nervous syst | Experimental | At least one of the following high-risk factors for CNS recurrence must be present: CNS-IPI score ≥ 4; or involving specific extranodal sites (such as testis, breast, adrenal gland, kidney, uterus, bone marrow, high-risk bones); or having ≥ 2 extranodal invasion sites. Receives: Drug: Lenalidomide; Drug: Bruton's tyrosine kinase inhibitor; Drug: Chidamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two-year cumulative recurrence rate of CNS
The cumulative proportion of patients who experienced central nervous system recurrence within 2 years after starting the trial drug treatment.
Measured: The cumulative proportion of patients who experienced central nervous system recurrence within 2 years after starting the trial drug treatment.
Secondary outcomes (2)
Progression-Free Survival (PFS)
From the time the experimental drug was administered until the date of the first recorded disease progression (in the central nervous system or systemically), recurrence, or death for any reason.
Measured: From enrollment to the end of treatment until 2 years
Overall survival (OS)
OS was defined as the time from cytarabine and thalidomide initiation to death or last follow-up.
Measured: From enrollment to the end of treatment until 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion1 Nov 2028 (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.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Model Description
- Masking
- None (open label)
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917624
- Sponsor's protocol ID
- 26/174-0500
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- 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 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Strategies for Preventing Central Nervous System Recurrence in Patients With Central High-risk Diffuse Large B-cell Lymphoma: A Prospective, Multicenter, Non-randomized Cohort Study
- ClinicalTrials.gov ID
- NCT07917624
- Acronym / sponsor ID
- 26/174-0500
- Conditions
- Diffuse Large B-Cell Lymphoma (DLBCL)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 4 Nov 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.
Background: The central nervous system (CNS) recurrence rate of patients with high-risk diffuse large B-cell lymphoma (DLBCL) is as high as 15% - 20%, and the prognosis is extremely poor once it occurs. Current intrathecal injection and high-dose methotrexate prophylaxis are ineffective and have significant toxicity. Lenalidomide, BTK inhibitors, and sidaribine all can penetrate the blood-brain barrier, and each has shown a signal of reducing the risk of CNS recurrence in previous studies, but there is still a lack of prospective concurrent comparative data.
Objective: To preliminarily evaluate the efficacy and safety of using these three oral drugs (lenalidomide, BTK inhibitors, and sidaribine) in combination with first-line immunotherapy chemotherapy for high-risk DLBCL patients to prevent CNS recurrence during the same period or after chemotherapy.
Method: This study is a phase II exploratory, open-label, non-randomized concurrent multi-cohort study, combined with historical external controls. A total of 87 patients with DLBCL diagnosed by histopathology and having at least one CNS high-risk factor (CNS-IPI ≥ 4 points, specific extranodal involvement (such as testis, breast, adrenal gland, kidney, uterus, bone marrow, bone), and extranodal invasion sites ≥ 2) are planned to be enrolled. Patients can choose to enter the lenalidomide group, BTK inhibitor group (ibrutinib, zanubrutinib, or obinutinib) or sidaribine group based on their disease characteristics and economic conditions, and the preventive treatment lasts for 1 year. The primary endpoint is the 2-year cumulative CNS recurrence rate (competitive risk model analysis), and the secondary endpoints include progression-free survival time, overall survival time, CNS disease-free survival time, and safety.
Significance: This study is the first to prospectively compare the CNS preventive value of these three drugs with different mechanisms in high-risk DLBCL patients, which is expected to provide key exploratory data for this field and lay the foundation for future confirmatory studies.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Model Description
| Arm | Type | Receives |
|---|---|---|
| Patients with diffuse large B-cell lymphoma who meet the criteria for high-risk central nervous syst | Experimental | Drug: Lenalidomide, Drug: Bruton's tyrosine kinase inhibitor, Drug: ChidamideAt least one of the following high-risk factors for CNS recurrence must be present: CNS-IPI score ≥ 4; or involving specific extranodal sites (such as testis, breast, adrenal gland, kidney, uterus, bone marrow, high-risk bones); or having ≥ 2 extranodal invasion sites. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. The diagnosis of diffuse large B-cell lymphoma, non-specific type or indolent lymphoma that has undergone large B-cell transformation, has been confirmed by histopathological examination; according to the 2016/2022 WHO classification, advanced B-cell lymphoma with dual expression/dual therapy is allowed; 2. Age between 18 and 80 years; 3. Proposed or currently receiving first-line standard immunotherapy, and planning to complete at least 6 cycles; 4. Baseline examination including brain-enhanced MR and cerebrospinal fluid cytology/flow cytometry by lumbar puncture was conducted to rule out CNS invasion; 5. Has at least one high-risk factor for CNS recurrence: CNS-IPI score ≥ 4 points; or involving specific extranodal sites (such as testis, breast, adrenal gland, kidney, uterus, bone marrow, high-risk bones); or extranodal invasion sites ≥ 2; 6. ECOG physical status score 0-2; 7. The subject can understand the study protocol and is willing to participate in this study, and signs a written informed consent.
Key exclusion criteria (1 listed)
- 1. Any evidence indicating the presence of CNS parenchymal, meningeal or intraocular lymphoma at the time of enrollment; 2. Having a history of myocardial infarction within 6 months prior to enrollment; suffering from New York Heart Association (NYHA) grade 3 or 4 congestive heart failure, or having a history of NYHA grade 3 or 4 congestive heart failure in the past, unless the left ventricular ejection fraction (LVEF) was ≥ 50% in the echocardiography (ECHO) screening conducted within 1 month before entering the study; 3. Pregnant or lactating women (baseline pregnancy test positive or not undergoing pregnancy test for women of childbearing age. Postmenopausal women must be at least 12 months post-menopause); 4. Having an uncontrollable infection; 5. Any other situation that the investigator deems the patient is not suitable to participate in this trial.
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 |
|---|---|---|
| LenalidomideThe dosage of lenalidomide is 25mg each time, once daily, taken with food or on an empty stomach. It is administered continuously from day 1 to day 21, with each 28-day period as one cycle. For elderly patients (aged > 75 years) or those with reduced renal function (creatinine clearance rate < 60 ml/min), the starting dose is reduced to 15mg. During the lenalidomide treatment, aspirin 100mg once daily or low molecular weight heparin is used to prevent thrombosis. The preventive drugs can be initiated simultaneously with chemotherapy or started 4-6 weeks after the completion of chemotherapy for continuous prevention, which is determined by the investigator. After the chemotherapy, it enters the single-agent maintenance stage, with the total prevention medication duration of 1 year (counting from the first administration), or until disease progression, intolerable toxicity occurs, or informed consent is withdrawn. | Drug | Patients with diffuse large B-cell lymphoma who meet the criteria for high-risk central nervous syst |
| Bruton's tyrosine kinase inhibitorThe BTK inhibitor group includes drugs such as Zanubrutinib, Obinutinib, and Ibrutinib. Their specific usage is as follows: Zanubrutinib, 160mg each time, taken twice daily before or after meals; Ibrutinib, 560mg each time, once daily, taken before or after meals; Obinutinib, 150mg each time, once daily, taken before or after meals. Preventive drugs can be initiated simultaneously with chemotherapy or started 4-6 weeks after the completion of chemotherapy, depending on the decision of the researchers. After the completion of chemotherapy, it enters the single-agent maintenance stage. The total preventive medication duration is 1 year (counting from the first administration), or until disease progression, intolerable toxicity occurs, or informed consent is withdrawn. | Drug | Patients with diffuse large B-cell lymphoma who meet the criteria for high-risk central nervous syst |
| ChidamideChidamide is administered at a dose of 20mg every 21 days. The medication is taken on days 1, 4, 8, and 11 of each cycle, 30 minutes after meals. The preventive medication can be initiated simultaneously with chemotherapy or started 4-6 weeks after the completion of chemotherapy, depending on the decision of the investigator. After the chemotherapy is completed, it enters the single-agent maintenance phase. The total preventive medication duration is 1 year (counting from the first administration), or until disease progression, intolerable toxicity occurs, or informed consent is withdrawn. | Drug | Patients with diffuse large B-cell lymphoma who meet the criteria for high-risk central nervous syst |
Primary outcome
Two-year cumulative recurrence rate of CNS
Time frame: The cumulative proportion of patients who experienced central nervous system recurrence within 2 years after starting the trial drug treatment.
The cumulative proportion of patients who experienced central nervous system recurrence within 2 years after starting the trial drug treatment.
2 secondary outcomes
Progression-Free Survival (PFS)
Time frame: From enrollment to the end of treatment until 2 years
Overall survival (OS)
Time frame: From enrollment to the end of treatment until 1 years
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 Nov 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lenalidomide, Bruton's tyrosine kinase inhibitor and Chidamide in people with Diffuse Large B-Cell Lymphoma (DLBCL), 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 1 inclusion and 1 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 Nov 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 XinXin XX Cao (+86-18618315968, caoxinxin@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two-year cumulative recurrence rate of CNS (time frame: The cumulative proportion of patients who experienced central nervous system recurrence within 2 years after starting the trial drug treatment.). 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 Nov 2026.