NL-OMON56379已完成3 期
A Phase 3, Randomized Study of Zanubrutinib (BGB-3111) Compared with Ibrutinib in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma - BeiGene BGB-3111-305
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Age 18 years or older
- •2. Confirmed diagnosis of CLL or SLL that meets the IWCLL criteria (Hallek et
- •3. CLL/SLL requiring treatment as defined by at least 1 of the following
- •a. Evidence of progressive marrow failure as manifested by the development of,
- •or worsening of, anemia and/or thrombocytopenia
- •b. Massive (>= 6 cm below left costal margin), progressive, or symptomatic
- •splenomegaly
- •c. Massive nodes (>= 10 cm in longest diameter), or progressive or symptomatic
- •lymphadenopathy
- •d. Progressive lymphocytosis with an increase of > 50% over a 2-month period or
- •lymphocyte-doubling time of < 6 months. Lymphocyte-doubling time may be
- •obtained by linear regression extrapolation of absolute lymphocyte counts
- •obtained at intervals of 2 weeks over an observation period of 2 to 3 months.
- •In patients with initial blood lymphocyte counts of < 30 x 109/L (30,000/uL),
- •lymphocyte-doubling time should not be used as a single parameter to define
- •treatment indication. In addition, factors contributing to lymphocytosis or
- •lymphadenopathy other than CLL/SLL (eg, infection) should be excluded.
- •e. Constitutional symptoms, defined as any 1 or more of the following
- •disease-related symptoms or signs:
- •i. Unintentional weight loss of >= 10% within the previous 6 months
- •ii. Significant fatigue (ie, inability to work or perform usual activities)
- •iii. Fevers > 100.5ºF or 38ºC for >= 2 weeks without other evidence of infection
- •iv. Night sweats for > 1 month without evidence of infection
- •4. Relapsed or refractory to at least 1 prior systemic therapy for CLL/SLL. A
- •line of therapy is defined as completing at least 2 cycles of treatment of
- •standard regimen according to current NCCN or ESMO guidelines or of an
- •investigational regimen on a clinical trial
- •5. Measurable disease by CT/magnetic resonance imaging (MRI). Measurable
- •disease is defined as >= 1 lymph node > 1.5 cm in longest diameter and
- •measurable in 2 perpendicular diameters or an extranodal lesion must measure >
- •10 mm in longest perpendicular diameter (LPD).
- •6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •7. Life expectancy >= 6 months
- •8. Adequate bone marrow function as defined by:
- •a. Absolute neutrophil count (ANC) >= 1000/mm3 (growth factor use is allowed),
- •except for patients with bone marrow involvement in which case ANC must be >=
- •- the screening hematology values confirming patient meets the ANC requirement
- •must be dated at least 14 days following the most recent administration of
- •pegfilgrastim and at least 7 days following the most recent administration of
- •other myeliod growth factions (eg, G-CSF, GM-CSF)
- •b. Platelet >= 75,000/mm3 (may be post-transfusion), except for patients with
- •bone marrow involvement by CLL in which case the platelet count must be >=
- •c. Hemoglobin >= 7.5 g/dL (may be post-transfusion)
- •9. Patient must have adequate organ function defined as:
- •a. Creatinine clearance >= 30 mL/min (as estimated by the Cockcroft-Gault
- •equation or the Modification of Diet in Renal Disease [MDRD] equation, or as
- •measured by nuclear medicine scan or 24-hour urine collection)
- •b. Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase,
- •and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase <= 2.5 ×
排除标准
- •1. Known prolymphocytic leukemia or history of, or currently suspected,
- •Richter*s transformation (biopsy based on clinical suspicion may be needed to
- •rule out transformation)
- •2. Clinically significant cardiovascular disease including the following:
- •a) Myocardial infarction within 6 months before screening
- •b) Unstable angina within 3 months before screening
- •c) New York Heart Association class III or IV congestive heart failure
- •(Appendix 4)
- •d) History of clinically significant arrhythmias (eg, sustained ventricular
- •tachycardia, ventricular fibrillation, Torsades de Pointes)
- •e) QTcF > 480 milliseconds based on Fridericia*s formula
- •f) History of Mobitz II second-degree or third-degree heart block without a
- •permanent pacemaker in place
- •g) Uncontrolled hypertension as indicated by a minimum of 2 consecutive blood
- •pressure measurements showing systolic blood pressure > 170 mmHg and diastolic
- •blood pressure > 105 mmHg at screening
- •3. Prior malignancy within the past 3 years, except for curatively treated
- •basal or squamous cell skin cancer, non-muscle-invasive bladder cancer, or
- •carcinoma in situ of the cervix or breast
- •4. History of severe bleeding disorder such as hemophilia A, hemophilia B, von
- •Willebrand disease, or history of spontaneous bleeding requiring blood
- •transfusion or other medical intervention
- •5. History of stroke or intracranial hemorrhage within 180 days before first
- •dose of study drug
- •6. Severe or debilitating pulmonary disease
- •7. Unable to swallow study drug or disease significantly affecting
- •gastrointestinal function such as malabsorption syndrome, resection of the
- •stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory
- •bowel disease, or partial or complete bowel obstruction
- •8. Active fungal, bacterial, and/or viral infection requiring systemic therapy
- •9. Known central nervous system involvement by leukemia or lymphoma
- •10. Underlying medical conditions that, in the investigator*s opinion, will
- •render the administration of study drug hazardous or obscure the interpretation
- •of toxicity or AEs
- •11. Known infection with HIV or serologic status reflecting active viral
- •hepatitis B or C infection as follows:
- •a. Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody
- •(HBcAb). Patients with presence of HBcAb, but absence of HBsAg, are eligible
- •if hepatitis B virus (HBV) DNA is undetectable (< 20 IU), and if they are
- •willing to undergo monitoring for HBV reactivation
- •b. Presence of hepatitis C virus (HCV) antibody. Patients with presence of HCV
- •antibody are eligible if HCV RNA is undetectable
- •12. Moderate or severe hepatic impairment, ie, Child-Pugh class B or C
- •13. Major surgery within 4 weeks of the first dose of study drug
- •14. Prior treatment with a BTK inhibitor
- •15. Last dose of prior therapy for CLL/SLL <= 14 days before randomization, with
- •the following additional exclusion requirements:
- •a.Treatment with monoclonal antibody-based therapy within 28 days of first dose
- •of study drug
- •b. Treatment with chimeric antigen receptor T-cell therapy within 180 days of
- 另有 5 项未显示
研究者
相似试验
进行中（未招募）
1 期
A study of Zanubrutinib Compared with Ibrutinib in patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic LymphomaChronic Lymphocytic Leukemia/Small Lymphocytic LymphomaMedDRA version: 21.1Level: LLTClassification code 10041152Term: Small lymphocytic lymphoma, consistent with CLL (Working Formulation)System Organ Class: 100000004864MedDRA version: 21.0Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 100000004864EUCTR2018-001366-42-CZBeiGene, Ltd.600
进行中（未招募）
1 期
A study of Zanubrutinib Compared with Ibrutinib in patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic LymphomaChronic Lymphocytic Leukemia/Small Lymphocytic LymphomaMedDRA version: 20.1Level: LLTClassification code 10041152Term: Small lymphocytic lymphoma, consistent with CLL (Working Formulation)System Organ Class: 100000004864MedDRA version: 20.1Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 100000004864EUCTR2018-001366-42-ESBeiGene, Ltd.400
进行中（未招募）
1 期
A study of Zanubrutinib Compared with Ibrutinib in patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic LymphomaEUCTR2018-001366-42-FRBeiGene, Ltd.400
进行中（未招募）
1 期
A study of Zanubrutinib Compared with Ibrutinib in patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic LymphomaEUCTR2018-001366-42-NLBeiGene, Ltd.650
进行中（未招募）
1 期
A study of Zanubrutinib Compared with Ibrutinib in patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic LymphomaEUCTR2018-001366-42-BEBeiGene, Ltd.600