Comparison of Outcome of Intensive Chemotherapy With and Without Venetoclax in Pediatric and Young Adult Acute Myeloid Leukemia Patients: A Non-Randomized Interventional Study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Post-induction flowcytometric measurable residual disease (Flow-MRD) response
研究概览
简要总结
This study aims to compare treatment outcomes in children and young adults with Acute Myeloid Leukemia (AML) receiving intensive chemotherapy with or without Venetoclax. The prospective group will receive Venetoclax in combination with standard intensive chemotherapy, while the historical control group received intensive chemotherapy alone. Outcomes will include post-induction measurable residual disease (MRD) response, complete remission rates, and treatment-related adverse events. The study will help determine whether adding Venetoclax improves remission rates and reduces residual disease. Findings may guide future treatment strategies for pediatric and young adult AML patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 2.00 Year(s) 至 39.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients up to 39 years of age diagnosed with Acute Myeloid Leukemia (AML).
- •2.Patients eligible for intensive chemotherapy.
- •3.Written informed consent obtained from parents/guardians and assent from patients when appropriate.
排除标准
- •Patients with contraindications to Venetoclax.
- •Acute Promyelocytic leukemia
- •Pregnant & Lactating mothers.
结局指标
主要结局
Post-induction flowcytometric measurable residual disease (Flow-MRD) response
时间窗: 18 months
次要结局
- Post-induction morphological complete response (CR) rates(18 months)
- Treatment-related adverse event profile(18 months)
研究者
Dr Nikhil Nagpal
AIIMS Rishikesh