NCT04458610进行中（未招募）2 期
BTK Inhibitor Zanubrutinib (BGB-3111) in Combination With Rituximab for Previously Untreated Patients With Chronic Lymphocytic Leukemia (CLL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Success rate
研究概览
简要总结
This phase II trial studies how well zanubrutinib and rituximab work in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma for which the patient has not received treatment in the past (previously untreated). Zanubrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. The study is being done to find out if zanubrutinib combined with rituximab can help control previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.
详细描述
PRIMARY OBJECTIVE:
I. To determine the proportion of patients who have treatment-free remission 6 months after discontinuation of zanubrutinib.
SECONDARY OBJECTIVES:
I. To determine clinical factors associated with a treatment-free remission of more than 6 months after discontinuation of zanubrutinib.
II. To determine the treatment-free remission length. III. To evaluate the efficacy of re-treatment with zanubrutinib plus rituximab in patients who relapse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients must have a diagnosis chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and be previously untreated
- •Patients must have an indication for treatment by 2018 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria
- •Patients must understand and voluntarily sign an informed consent, and be able to comply with study procedures and follow-up examinations
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •Patients of childbearing potential must be willing to practice highly effective birth control (e.g., condoms, implants, injectables, combined oral contraceptives, intrauterine devices [IUDs], sexual abstinence, or sterilized partner) during the study and for 30 days after the last dose of study drug. Women of childbearing potential include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal
- •Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) except for patients with bilirubin elevation due to Gilbert's disease who will be allowed to participate
- •An alanine aminotransferase (ALT) =< 2.5 x ULN
- •An estimated creatinine clearance (CrCl) of > 30 mL/min, as calculated by the Cockcroft-Gault equation unless disease related
- •Free of prior malignancies for 3 years with exception of currently treated basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast. If patients have another malignancy that was treated within the last 3 years, such patients can be enrolled, after consultation with the principal investigator, if the likelihood of requiring systemic therapy for this other malignancy within 2 years is less than 10%, as determined by an expert in that particular malignancy
- •A urine pregnancy test (within 7 days of day 1) is required for women with childbearing potential
排除标准
- •Pregnant or breast-feeding females
- •Prior therapy with zanubrutinib or other kinase inhibitors that target BCR signaling (such as ibrutinib, idelalisib)
- •Prior CLL-directed treatment including chemotherapy, chemo-immunotherapy, monoclonal antibody therapy, radiotherapy, high-dose corticosteroid therapy (more than 60 mg prednisone daily or equivalent), or immunotherapy within 21 days prior to enrollment or concurrent with this trial. Patients that receive zanubrutinib salvage therapy cannot have received any other CLL-directed therapy besides frontline zanubrutinib plus rituximab
- •Investigational agent received within 30 days prior to the first dose of study drug. If received any investigational agent prior to this time point, drug-related toxicities must have recovered to grade 1 or less prior to first dose of study drug
- •Systemic fungal, bacterial, viral, or other infection not controlled by antimicrobial therapy, in the assessment of the treating physician(s) and/or the principal investigator
- •Patients with uncontrolled autoimmune hemolytic anemia (AIHA) or autoimmune thrombocytopenia (ITP), i.e. with laboratory signs of active hemolysis or thrombocytopenia, requiring support with blood products and/or with rapid decline in hemoglobin (> 1 gram/dL per day) or platelet counts (> 10,000/uL per day)
- •Patients with severe hematopoietic insufficiency, as defined by an absolute neutrophil count of less than 500/uL, unless disease-related, and/or a platelet count of less than 30,000/uL at time of screening for this protocol
- •Any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver or other organ system that may place the patient at undue risk to undergo therapy with zanubrutinib and rituximab
- •Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification. Patients with a history of paroxysmal atrial fibrillation (PAF) or deep vein thrombosis or pulmonary embolism (DVT/PE) can be included if they had no signs of PAF or DVT/PE in the last 6 months before enrolment. Patients with ongoing atrial fibrillation (AFib) or ongoing PAF or DVT/PE should be excluded
- •History of stroke or cerebral hemorrhage within 6 months
- •Evidence of bleeding diathesis or coagulopathy within 3 months
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 1, anticipation of need for major surgical procedure during the course of the study
- •Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to day
- •Bone marrow aspiration and/or biopsy are allowed
- •Serious, non-healing wound, ulcer, or bone fracture
- •Treatment with warfarin (Coumadin) or any other vitamin K antagonist. Patients who recently received warfarin must be off warfarin for at least 7 days prior to start of the study. Patients receiving novel oral anticoagulant (NOAC), also termed direct oral anticoagulant (DOAC) are permitted to enroll. Patients who are currently on a vitamin K antagonist must be switched to a non-vitamin K antagonist, such as a NOAC/DOAC
- •Patients with active hepatitis B (hepatitis B virus [HBV]) or hepatitis C
- •Patients with known human immunodeficiency virus (HIV) infection
研究组 & 干预措施
Treatment (zanubrutinib, rituximab)
Experimental
See Detailed Description.
干预措施: Rituximab (Biological)
Treatment (zanubrutinib, rituximab)
Experimental
See Detailed Description.
干预措施: Zanubrutinib (Drug)
结局指标
主要结局
Success rate
时间窗: At 6 months after discontinuation of zanubrutinib
Will estimate the proportion of patients who have treatment-free remission 6 months after discontinuation of zanubrutinib. Success rate will be estimated with 95% credible interval and confidence interval.
次要结局
- Overall response(After 6 cycles of treatment (each cycle is 28 days))
- Clinical factors associated with a treatment-free remission of more than 6 months after discontinuation of zanubrutinib(Up to 5 years after discontinuation of zanubrutinib)
- Treatment-free remission length(Up to 5 years after discontinuation of zanubrutinib)
研究者
研究点 (1)
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