NCT07917624Not yet recruitingPhase 2
Prophylactic Strategies for Mitigating Central Nervous System Relapse in Diffuse Large B-Cell Lymphoma
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
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 87 (estimated)
- First submitted
- 30 Oct 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 31 Oct 2028
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT07917624
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 87
- From 1 Nov 2026 to the primary completion date, 31 Oct 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 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, Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.