NL-OMON53142已完成2 期
An Open-label, Phase 2 Study of ACP-196 in Subjects with Waldenström Macroglobulinemia - ACE-WM-001
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 7
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
- 年龄范围
- 18 至 64（—）
入选标准
- •Men and women >= 18 years of age.
- •Previously treated cohort only: A confirmed diagnosis of WM, which has
- •relapsed after, or been refractory to >= 1 prior therapy for WM and which
- •requires treatment.
- •Previously untreated cohort only: A confirmed diagnosis of previously
- •untreated WM in subjects who require treatment and do not want to receive
- •chemoimmunotherapy or have comorbidities that would preclude chemoimmunotherapy
- •o Symptomatic hyperviscosity with an IgM >= 5,000 mg/dL
- •o Disease-related neuropathy
- •Serum concentration of IgM, as measured by serum protein electrophoresis
- •(SPEP) and immunofixation electrophoresis (IFE), that exceeds the upper limits
- •of normal or measurable nodal WM (defined as the presence of >= 1 lymph node
- •that measures >= 2.0 cm in the longest diameter and >= 1.0 cm in the longest
- •perpendicular diameter).
- •Eastern Cooperative Oncology Group (ECOG) performance status of <= 2.
- •Agreement to use highly effective forms of contraception during the study and
- •for 90 days after the last dose of acalabrutinib. Highly effective forms of
- •contraception are defined in Section 3.7.4 .
- •Agreement to refrain from sperm donation during the study and for 90 days
- •after the last dose of acalabrutinib.
- •Willing and able to participate in all required evaluations and procedures in
- •this study protocol including swallowing capsules without difficulty.
- •Ability to understand the purpose and risks of the study and provide signed
- •and dated informed consent and authorization to use protected health
- •information (in accordance with national and local patient privacy
- •regulations).
排除标准
- •Prior malignancy, except for adequately treated basal cell or squamous cell
- •skin cancer, in situ cervical cancer, or other cancer from which the subject
- •has been disease free for >= 2 years or which will not limit survival to < 2
- •years. Note: These cases must be discussed with the medical monitor.
- •A life-threatening illness, medical condition, or organ system dysfunction
- •which, in the investigator*s opinion, could compromise the subject*s safety,
- •interfere with the absorption or metabolism of acalabrutinib, or put the study
- •outcomes at undue risk.
- •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, or corrected QT interval (QTc) >
- •Malabsorption syndrome, disease significantly affecting gastrointestinal
- •function, or resection of the stomach or small bowel or gastric bypass,
- •symptomatic inflammatory bowel disease, or partial or complete bowel
- •obstruction.
- •Any immunotherapy within 4 weeks of first dose of study drug.
- •For subjects with recent chemotherapy or experimental therapy, the first dose
- •of study drug must occur after 5 times the half-life of the agent(s).
- •Prior exposure to a BCR inhibitor (eg, BTK, phosphoinositide-3 kinase [PI3K],
- •or spleen tyrosine kinase [SYK] inhibitors) or B-cell lymphoma 2 (BCL-2)
- •inhibitor (eg, ABT-199).
- •Ongoing immunosuppressive therapy, including systemic or enteric
- •corticosteroids, for treatment of WM or other conditions. Note: Subjects may
- •use topical or inhaled corticosteroids or low-dose steroids (<= 10 mg of
- •prednisone or equivalent per day) as therapy for comorbid conditions. During
- •study participation, subjects may also receive systemic or enteric
- •corticosteroids as needed for treatment-emergent comorbid conditions.
- •Grade >= 2 toxicity (other than alopecia) continuing from prior anticancer
- •therapy including radiation.
- •Known history of human immunodeficiency virus (HIV) or active infection with
- •hepatitis C virus (HCV) or hepatitis B virus (HBV) or any uncontrolled active
- •systemic infection.
- •Major surgery within 4 weeks before first dose of study drug.
- •Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia
- •History of a bleeding diathesis (eg, hemophilia, von Willebrand disease)
- •History of stroke or intracranial hemorrhage within 6 months before the first
- •dose of acalabrutinib.
- •Requires or receiving anticoagulation with warfarin or equivalent vitamin K
- •antagonist (eg, phenprocoumon) within 28 days of first dose of study drug.
- •Requires treatment with proton-pump inhibitors (eg, omeprazole, esomeprazole,
- •lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole)
- •Absolute neutrophil count (ANC) < 0.75 x 109/L or platelet count < 50 x
- •109/L. For subjects with disease involvement in the bone marrow, ANC < 0.50 x
- •109/L or platelet count < 30 x 109/L.
- •Creatinine > 2.5 x institutional upper limit of normal (ULN); total bilirubin
- •> 2.5 x ULN; or aspartate aminotransferase (AST) or alanine aminotransferase
- •(ALT) > 3.0 x ULN.
- •Lactating or pregnant.
- •Concurrent participation in another therapeutic clinical trial.
研究者
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