Combining Rituximab, Zanubrutinib, and Lenalidomide for CNS Lymphoma Treatment
Rituximab,Zanubrutinib in Combination With Lenalidomide, Followed by Zanubrutinib or Lenalidomide Maintenance in Patients With Primary or Secondary CNS Lymphoma
This study is testing a new combination of three medications to see if they can help people with central nervous system lymphoma who haven't responded well to regular chemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Henan Cancer Hospital Government |
| Drugs / interventions | chemotherapy, rituximab, zanubrutinib |
| Locations | 1 site (Zhengzhou, Henan) |
| Trial ID | NCT04938297 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of a combination of Rituximab, Zanubrutinib, and Lenalidomide in treating patients with primary or secondary central nervous system lymphoma. The study aims to assess the synergistic effects of these medications, particularly in patients who have not responded well to standard chemotherapy. Additionally, it will compare the efficacy of maintenance therapy using either Zanubrutinib or Lenalidomide after the initial treatment phase.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed diffuse large B-cell lymphoma and either untreated primary CNS lymphoma or recurrent/refractory disease.
Not a fit: Patients with non-CNS lymphoma or those who are not histologically confirmed to have diffuse large B-cell lymphoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective treatment option for patients with CNS lymphoma, potentially improving outcomes and reducing complications associated with traditional chemotherapy.
How similar studies have performed: While there have been studies exploring similar combinations, this specific approach is novel in the context of CNS lymphoma treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * voluntarily participate in clinical research, fully understand the study and sign the informed consent form (ICF), willing to follow and be able to complete all research steps * histologically confirmed diffuse large B-cell lymphoma (DLBCL), all subjects must provide enough archived or fresh tumor tissue samples for immunhistochemistry (IHC) and gene expression profile (GEP) evaluation * For untreated primary CNS lymphoma, patients should be with an age of 65 years or older, intolerable to first-line treatment * Recurrent or refractory disease was defined as: 1) recurrence of disease after complete remission (CR), or 2) partial remission (PR), stable disease (SD), or progressive disease (PD) at the time of completion of treatment before inclusion * Recurrent / refractory diffuse large B-cell lymphoma with CNS involvement confirmed by histopathology or imaging * Age ≥ 18 years, ECoG score ≤ 2, expected survival time is more than 3 months * Patients with solid lesions must obtain clear evidence of disease progression through imaging examination (head MRI or head CT) 21 days before enrollment. For patients with leptomeningeal involvement only, CSF cytology examination must confirm lymphoma cells and / or imaging findings consistent with CSF disease 21 days before enrollment (at the discretion of the investigator) * With sufficient organ and bone marrow function , and no severe hematopoietic, heart, lung, liver, kidney, thyroid dysfunction and immune deficiency * at least 100 days after transplantation for recurrent patients after ATST Exclusion Criteria: * Histologically transformed large cell lymphoma * History of previous transplantation of allogeneic stem cells * Received BTKi or Lenalidomide * Received corticosteroid within 7 days for antitumor treatment * Received chemotherapy, radiotherapy, monoclonal antibody, experimental treatment, or traditional Chinese Medicine within 4 weeks * Received major surgery within 4 weeks * Active malignant diseases within 2 years before entering the study * Clinically significant cardiovascular diseases * History of severe bleeding diseases * history of stroke or intracranial hemorrhage within 6 months before the first administration * Unable to swallow capsules or have diseases that significantly affect gastrointestinal function * Uncontrolled systemic infection requiring parenteral anti infective therapy * HIV infection or indicate active hepatitis B or C virus infection * Drug allergies or metabolic disorders * Pregnant or lactating women * Any life-threatening diseases, medical conditions or organ system dysfunction that the researchers believe may affect the safety of the subjects or lead to research risks * Required to continuously treated with potent and moderate CYP3A inhibitors or inducers * History of deep venous thrombosis (DVT) or pulmonary embolism (PE) in the past 12 months
Where this trial is running
Zhengzhou, Henan
- Henan cancer hospital — Zhengzhou, Henan, China (Recruiting)
Study contacts
- Study coordinator: Keshu Zhou, Dr.
- Email: drzhouks77@163.com
- Phone: 13674902391
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.