A Phase 1B, Open-label, Global, Multicenter, Dose Determination Study to Evaluate Safety, Tolerability, and Preliminary Efficacy of CC-486 (ONUREG®) in Combination Therapy in Subjects With Acute Myeloid Leukemia (AML)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 6
- 试验地点
- 10
- 主要终点
- Maximum Tolerated Dose (MTD)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of CC-486 (ONUREG®) in combination with venetoclax in relapsed and/or refractory Acute Myeloid Leukemia (AML) and newly diagnosed AML.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmation of the following for Acute Myeloid Leukemia (AML)
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or
- •ECOG 3 is allowed if participants are 18 to 74 years old with comorbidities
- •Agree to serial bone marrow aspirate/biopsies
排除标准
- •Suspected or proven to have acute promyelocytic leukemia based on morphology, immunophenotype, molecular assay, or karyotype
- •Received prior hypomethylating agent (HMA) therapy for myelodysplastic syndromes/Chronic myelomonocytic leukemia then develop AML within 4 months of discontinuing the HMA therapy
- •Prior history of malignancy unless the participant has been free of the disease for ≥ 1 year prior to the start of study treatment
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
CC-486 in combination with Venetoclax
干预措施: CC-486 (Drug)
CC-486 in combination with Venetoclax
干预措施: Venetoclax (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD)
时间窗: Up to 42 days after first dose
Incidence of relationship of AEs to study treatment
时间窗: From informed consent form (ICF) signature to 28 days after last dose of study drug
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
时间窗: From informed consent form (ICF) signature to 28 days after last dose of study drug
Incidence of type of adverse events (AEs)
时间窗: From informed consent form (ICF) signature to 28 days after last dose of study drug
Incidence of frequency of AEs
时间窗: From informed consent form (ICF) signature to 28 days after last dose of study drug
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
时间窗: From informed consent form (ICF) signature to 28 days after last dose of study drug
Incidence of severity of AEs
时间窗: From informed consent form (ICF) signature to 28 days after last dose of study drug
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
时间窗: From informed consent form (ICF) signature to 28 days after last dose of study drug
次要结局
- Overall Response Rate (ORR)(Up to approximately 12 months)
- Minimal Residual Disease (MRD) Response Rate(Up to approximately 12 months)
- MRD Conversion Rate(Up to approximately 12 months)
- Rate of complete remission (CR)/complete remission with incomplete recovery of blood counts (CRi)(Up to approximately 12 months)
- Rate of complete remission (CR)/complete remission with partial hematologic recovery (CRh)(Up to approximately 12 months)