A Phase 2 Clinical Study of SHP674 in Patients With Newly Diagnosed, Untreated Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 8
- 主要终点
- Part 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and SHP-674-Related TEAEs During the Tolerability Assessment Period
研究概览
简要总结
The objectives of the study are to assess the safety and tolerability of a single dose of SHP674 in Japanese participants (dose confirmation) in the tolerability assessment period of Part 1 and to assess the safety, pharmacokinetics and efficacy of SHP674 dose in Part 2 (found to be tolerated in Part 1) in the treatment of newly diagnosed untreated acute lymphoblastic leukemia (ALL) in Japanese participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 1 to ≤21 years at the time of informed consent;
- •Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 2;
- •Newly diagnosed, untreated precursor B-cell ALL
- •No prior therapy for malignant tumor such as chemotherapy and radiation therapy before signing the informed consent;
- •Life expectancy of at least 6 months from the date of enrollment;
排除标准
- •Mature B-cell ALL ; Philadelphia chromosome-positive (Ph+) or BCR-ABL1-positive ALL
- •Preexisting known coagulopathy ;
- •History of pancreatitis;
- •Continuous use of corticosteroids;
- •Prior treatment or possible prior treatment with an L-asparaginase preparation;
- •History of sensitivity to polyethylene glycol (PEG) or PEG-based drugs;
结局指标
主要结局
Part 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and SHP-674-Related TEAEs During the Tolerability Assessment Period
时间窗: Up to 30 days after last dose of study drug (approximately 49 weeks)
An adverse event (AE) is defined as any untoward medical occurrence in a participant after signing informed consent. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease, whether or not it is related to the investigational product. TEAE is defined as any untoward medical occurrence in a participant who received an investigational product which occurs during the period from Day 1 of the pre-treatment phase to 30 (+7) days after the last dose of investigational product, or until the start of a new therapy, whichever occurs first. A related adverse event signifies that there is a reasonable causal relationship between study treatment and an AE.
Part 2: Percentage of Participants Who Achieved a Plasma Asparaginase Activity of ≥0.1 International Units Per Milliliter (IU/mL) 14 Days (336 Hours) After the First Dose of SHP674
时间窗: 14 days after the first dose of SHP674
次要结局
- Percentage of Participants With Anti-Polyethylene Glycol (PEG) Antibody (Part 1 and Part 2)(Predose and 25 days post dose (Part 1 and part 2))
- Part 1: Percentage of Participants Who Achieved a Plasma Asparaginase Activity of ≥0.1 IU/mL 14 Days (336 Hours) After the First Dose of SHP674(14 days after the first dose of SHP674)
- Part 2: Percentage of Participants With Plasma Asparaginase Activity of ≥0.1 IU/mL or <0.1 IU/mL(Day 1 (pre-dose, 5 min, 4 hours, 24 hours post dose), Days 2, 4, 11, 14, 18, 25 post dose)
- Percentage of Participants With Anti-Drug (SHP674) Antibody (ADA) (Part 1 and Part 2)(Predose and 25 days post dose (Part 1 and Part 2))
- Survival Rate at 1 Year After the Start of Study Treatment(1 year after the start of study treatment (from first dose up to 12 months))
- Event-free Survival Rate at 1 Year After the Start of Study Treatment(1 year after the start of study treatment (from first dose up to 12 months))