A Phase 2a, Multi-centre, Randomised, Double-blinded, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of Pyronaridine as an Add-on Therapy in Adults With Acute Lymphoblastic Leukemia and Acute Myeloid Leukemia
试验速览
- 阶段
- 2 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in survival lengths to 1 year
研究概览
简要总结
A Phase 2a clinical trial on up to n=200 male and female subjects 18 years and over who were diagnosed with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL). Subjects are randomised in approximately a 1:1 ratio to receive standard of care treatment plus either pyronaridine (PND) or placebo. Quality of life parameters are measured. Visits include physical examinations, and blood draws for complete blood count with differential (CBC) and complete metabolic panel (CMP). Survival of subjects is tracked in Year 2.
详细描述
The primary objective is the difference in survival lengths in days between the study arm receiving pyronaridine and the study arm receiving placebo as measured from the date of the first diagnosis of acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL). Secondary objectives are differences between the active and placebo study arms in quality of life, laboratory data values and in the safety and tolerability of treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All capsules contain either pyronaridine or similar-appearing placebo.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must have a diagnosis within 60 days of the time of study entry of either acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML). If the physician is a third-party physician, then the study site must obtain the subject's medical records from the clinic where the first diagnosis was made.
- •Subjects must be on standard of care therapy for ALL or AML. The standard of care therapy may be initiated at time of study entry.
- •Subjects must be 18 years of age or older, and male or female.
- •Subjects must weigh between 40kg and 90kg at time of study entry.
- •Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) at least 14 days prior to study entry, for the duration of study participation, and at least 30 days after completion of drug administration. Women of child-bearing potential must agree to pregnancy tests for the duration of the study. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, the study subject should inform her investigator immediately.
- •Men must agree to always use a condom during intercourse for the duration of study participation, and for at least 30 days after completion of drug administration.
- •Subjects must have the ability to swallow size "0" gelatin capsules.
- •Subject must be willing to agree to and comply with all requirements of the study.
- •Subjects must have the ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Subjects with malaria.
- •Subjects who are pregnant or nursing.
- •Subjects who have had major surgery within 30 days prior to study entry.
- •Subjects with active clinically significant infection or uncontrolled illness, except ALL or AML.
- •Subjects with evidence of chronic hepatitis B (HBV) infection.
- •Subjects with evidence or history of hepatitis C (HCV) infection.
- •Subjects with a prior or concurrent malignancy (basal cell carcinoma and squamous cell skin cancer are allowed).
- •Subjects with evidence of other disease or any concomitant medical or psychiatric problem which in the opinion of the investigator would put them at risk.
- •Subjects with a known hypersensitivity to pyronaridine tetraphosphate or compounds of similar chemical composition, or microcrystalline cellulose (MCC) the placebo agent.
- •Subjects who are receiving any other investigational agents or who have received any investigational medication within the past 30 days.
研究组 & 干预措施
Standard of care treatment plus pyronaridine
Standard of care treatment plus pyronaridine
干预措施: Pyronaridine Tetraphosphate (Drug)
Standard of care treatment plus placebo
Standard of care treatment plus placebo
干预措施: Pyronaridine Tetraphosphate (Drug)
结局指标
主要结局
Change in survival lengths to 1 year
时间窗: 1 year
The primary endpoint is the change in survival lengths in days between the study arm receiving pyronaridine and the study arm receiving placebo as measured from the date of the first known acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) diagnosis within 60 days of the time of study entry.
次要结局
未报告次要终点