NCT02157324进行中（未招募）1 期
A Multicenter, Open-label, Phase 1 Pilot Study of ACP-196 in Combination With ACP-319 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
This study is evaluating the safety and efficacy of the combined use of acalabrutinib and ACP-319, for the treatment of chronic lymphocytic leukemia (CLL)
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
- •Men and women ≥ 18 years of age with a confirmed diagnosis of CLL, which has relapsed after, or been refractory to, ≥ 1 previous treatments for CLL; however, subjects with 17p deletion are eligible if they have relapsed after, or been refractory to, 1 prior treatment for CLL.
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤
- •Agreement to use contraception during the study and for 30 days after the last dose of study drugs if sexually active and able to bear or beget children.
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.
- •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 and/or ACP-319, or put the study outcomes at undue risk.
- •Significant cardiovascular disease.
- •Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, 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).
- •History of prior allogeneic bone marrow progenitor cell or solid organ transplantation.
- •Ongoing immunosuppressive therapy, including systemic or enteric corticosteroids for treatment of CLL or other conditions. Note: Subjects may be using topical or inhaled corticosteroids as therapy for comorbid conditions.
- •Central nervous system (CNS) involvement by CLL.
- •Grade ≥ 2 toxicity (other than alopecia).
- •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.
- •Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura.
- •Absolute neutrophil count (ANC) < 0.75 x 109/L or platelet count < 50 x 109/L unless due to disease involvement in the bone marrow.
- •Creatinine > 1.5 x institutional upper limit of normal (ULN); total bilirubin > 1.5 x ULN (unless due to Gilbert's disease); and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 x ULN unless disease related.
- •Significant screening ECG abnormalities including left bundle branch block, 2nd degree AV block type II, 3rd degree block, Grade 2 or higher bradycardia, and QTc > 480 msec.
研究组 & 干预措施
acalabrutinib
Experimental
Starts with acalabrutinib for 7 days, then combined with ACP-319 afterwards.
干预措施: acalabrutinib (Drug)
acalabrutinib
Experimental
Starts with acalabrutinib for 7 days, then combined with ACP-319 afterwards.
干预措施: ACP-319 (Drug)
ACP-319
Experimental
Starts with ACP-319 for 7 days, then combined with acalabrutinib afterwards.
干预措施: acalabrutinib (Drug)
ACP-319
Experimental
Starts with ACP-319 for 7 days, then combined with acalabrutinib afterwards.
干预措施: ACP-319 (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: From date of randomization until the day of documented progression or date of death from any cause, whichever came first, assessed up to 60 cycles of 28 days.
The frequency (number and percentage) of treatment-emergent AEs will be reported in each treatment group by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class and Preferred Term. Summaries will also be presented by the severity of the AE (per CTCAE, v4.03) and by relationship to study drug.
次要结局
- Duration of Response(Pretreatment, then end of cycles 2, 4, 9, 12, 18 and then every 6 cycles to cycle 36. After that at cycle 48 and 60 of 28 day cycles.)
- Drug Exposure, Maximum observed plasma concentration(From 30 min before first dose to 30 min before day-28 of cycle-6 of 28 day cycles)
- Drug Exposure, Time of the maximum plasma concentration(From 30 min before first dose till 30 before day-28 of cycle-6 of 28 day cycles)
- Drug Exposure, Area Under the Plasma Concentration-time Curve(From 30 min before first dose to day-28 of cycle-6 of a 28 day cycle)
- Progression-Free Survival(Pretreatment, then end of cycles 2, 4, 9, 12, 18 and then every 6 cycles to cycle 36. After that at cycle 48 and 60 of 28 day cycles.)
- Overall Response rate(Pretreatment, then end of cycles 2, 4, 9, 12, 18 and then every 6 cycles to cycle 36. After that at cycle 48 and 60 of 28 day cycles.)
研究者
研究点 (1)
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