A Multicenter, Open-Label, 2-Stage, Phase II Study of Single-Agent Obatoclax Mesylate Administered For Three Consecutive Days Every 2 Weeks to Older Patients With Previously Untreated Acute Myeloid Leukemia (AML)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 13
- 主要终点
- Determine the rate of morphologic CR after treatment in the obatoclax single-agent therapy in older patients with previously untreated AML.
研究概览
简要总结
This protocol will evaluate the efficacy of obatoclax in older patients with previously untreated AML.
详细描述
The Pilot Safety portion of the study will evaluate the safety of obatoclax administered by a 3 hour infusion for 3 days in a row. The Pilot Schedule portion of the study will randomize 16 patients in to one of two cohorts: 1) patients receiving obatoclax administered by a 3 hour infusion for 3 days in a row or 2) patients receiving obatoclax administered by a 24 hour infusion for 3 days in a row. The schedule with the best overall efficacy and safety in the Pilot Schedule portion of the study will then be utilized in the Phase II portion of the study.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed AML
- •No prior chemotherapy for AML (with the exception that the patients enrolled in the Pilot Safety evaluation may have had 1 prior therapy)
- •Age ≥70 years
- •Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2
- •Patients must have normal organ function as defined below:
- •Total bilirubin < or = 2 mg/dL unless resulting from hemolysis,
- •Aspartate transaminase (AST [SGOT])/alanine transaminase (ALT [SGPT]) < or = 2.5 x institutional ULN
- •Creatinine within normal institutional limits, OR creatinine clearance > or = 50 mL/min/1.73 meters squared for patients with creatinine levels above institutional ULN
排除标准
- •Patients who have received or are receiving any other investigational or commercial agents or therapies administered with the intent to treat their malignancy (with the exception that the patients enrolled in the pilot safety evaluation may have had 1 prior therapy)
- •patients with history of allergic reactions attributed to components of the formulated product (PEG300 and polysorbate 20)
- •patients with history of seizure disorders or central nervous system leukemia
- •patients with uncontrolled, intercurrent illness including, but not limited to, symptomatic neurological illness; active, uncontrolled, systemic infection considered opportunistic, life-threatening, or clinically significant at the time of treatment; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; significant pulmonary disease or hypoxia; or psychiatric illness/social situations that would limit compliance with study requirements
- •Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy
研究组 & 干预措施
Experimental
In the Pilot Schedule portion of the study 3 hour vs 24 hour infusion schedules of obatoclax.
干预措施: Obatoclax (Drug)
结局指标
主要结局
Determine the rate of morphologic CR after treatment in the obatoclax single-agent therapy in older patients with previously untreated AML.
时间窗: 4 weeks
次要结局
未报告次要终点