Phase 1 Study of Asciminib Maintenance Therapy Following Allogeneic Stem Cell Transplant or Chimeric Antigen Receptor T Cell Therapy (CAR T) to Prevent Relapse in Adults With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Recommended Phase 2 Dose
研究概览
简要总结
The purpose of the study is to see if a study drug called asciminib is safe and okay for people to take after they've had treatment for a type of blood cancer called Philadelphia Chromosome
Positive Acute Lymphoblastic Leukemia (Ph+ B-ALL). We're looking at two groups of adults:
one group had an Allogeneic Stem Cell Transplant (alloHCT) cohort A, and the other group had chimeric antigen receptor T cell (CAR T) therapy, cohort B. We also want to figure out what the best dose of asciminib is to use moving forward in future studies.
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
- •Age ≥18 years
- •Diagnosis of Ph+ B-ALL with detectable Philadelphia chromosome abnormalities
- •Morphologic remission (<5% marrow blasts)
- •ECOG performance status 0-2
- •Adequate organ function
排除标准
- •Active relapsed disease (>5% blasts)
- •Grade II-IV acute GVHD requiring systemic steroids
- •Significant organ dysfunction or uncontrolled infection
- •Pregnancy or breastfeeding
- •Prior investigational CAR T product
研究组 & 干预措施
Patients post-alloHCT
Individuals who have previously undergone an allogeneic stem cell transplant (alloHCT).
干预措施: Asciminib (Drug)
Patients post-CAR T cell therapy
Individuals who have received chimeric antigen receptor T cell therapy (CAR T).
干预措施: Asciminib (Drug)
结局指标
主要结局
Recommended Phase 2 Dose
时间窗: Up to 24 months
The MTD is defined as the highest dose level at which one or none of six patients experience a DLT.
次要结局
- Relapse-free survival (RFS)(Up to 24 Months)
- Overall survival (OS)(Up to 24 Months)