Rituximab,Zanubrutinib in Combination With Lenalidomide, Followed by Zanubrutinib or Lenalidomide Maintenance in Patients With Primary or Secondary CNS Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Overall response rate
研究概览
简要总结
In view of the synergistic effects of rituximab, zanubrutinib, and lenalidomide and severe complications caused by current standard chemotherapy regimens in Patients for primary or secondary CNS lymphoma, we intend to conduct a prospective clinical study to evaluate the efficacy and toxicity of Rituximab, Zanubrutinib in combination with Lenalidomide. Besides, the efficacy of Zanubrutinib or Lenalidomide in maintenance was also compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Recurrent/refractory diffuse large B-cell lymphoma with CNS invasion
8 cycles of induction ZR2, followed by Lenalidomide maintenance for CR/PR fit patients.
干预措施: Rituximab, Lenalidomide, Zanubrutinib (Drug)
Primary CNS Lymphoma，age>65
8 cycles of induction ZR2 , followed by Zanubrutinib or Lenalidomide maintenance for CR/PR fit patients through randomization by 1:1 ration
干预措施: Rituximab, Lenalidomide, Zanubrutinib (Drug)
Primary CNS Lymphoma，age>65
8 cycles of induction ZR2 , followed by Zanubrutinib or Lenalidomide maintenance for CR/PR fit patients through randomization by 1:1 ration
干预措施: Lenalidomide, Zanubrutinib (Drug)
Recurrent/refractory primary CNS lymphoma
8 cycles of induction ZR2, followed by Lenalidomide maintenance for CR/PR fit patients.
干预措施: Rituximab, Lenalidomide, Zanubrutinib (Drug)
Recurrent/refractory primary CNS lymphoma
8 cycles of induction ZR2, followed by Lenalidomide maintenance for CR/PR fit patients.
干预措施: Lenalidomide (Drug)
Recurrent/refractory diffuse large B-cell lymphoma with CNS invasion
8 cycles of induction ZR2, followed by Lenalidomide maintenance for CR/PR fit patients.
干预措施: Lenalidomide (Drug)
结局指标
主要结局
Overall response rate
时间窗: at the end of 8 cycles of induction therapy (each cycle is 28 days)
To evaluate the overall response rate of ZR2 in the treatment of CNS Lymphoma
次要结局
- Overall response rate(at the end of 4 cycles of induction therapy (each cycle is 28 days) and 1 year of maintenance therapy)
- Progression-free survival (PFS) rate(at the end of 8 cycles of induction therapy (each cycle is 28 days), 1 year and 2 year of maintenance therapy)
- Overall survival（OS）rate(at the end of 8 cycles of induction therapy (each cycle is 28 days), 1 year and 2 year of maintenance therapy)
- Treatment related adverse events(at the end of 8 cycles of induction therapy (each cycle is 28 days), 1 year and 2 year of maintenance therapy)
研究者
zhoukeshu
Associate Director of Hematology
Henan Cancer Hospital