A Study of VA Combined With PD-1 Inhibitor in the Treatment of Relapsed and Refractory AML and High-risk MDS
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Complete minimal residual disease (MRD) Response Rate
研究概览
简要总结
The efficiency and safety of PD-1 inhibitor in combination with venetoclax and hypomethylation agent in relapsed/refractory acute myeloid leukemia or high-risk myelodysplastic syndrome remain uncertain. In this study, the investigators aimed to assess safety and response to a new PD-1 inhibitor-based triple-drug combination regimen (venetoclax + hypomethylation agent + PD-1 inhibitor) in relapsed/refractory acute myeloid leukemia and high-risk myelodysplastic syndrome patients, or who had positive minimal residual disease.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with relapsed and refractory acute myeloid leukemia (AML) and patients diagnosed with myelodysplastic syndrome (MDS) who require chemotherapy treatment.
- •Patients who did not respond or had disease recurrence after 1 course of induction chemotherapy or had positive immune residues after induction chemotherapy or positive molecular residues (if any) after induction chemotherapy.
- •Voluntarily participate in clinical research and sign an informed consent form and be willing to follow and be able to complete all experimental procedures.
- •The toxic and side effects caused by the last treatment should be recovered.
- •Eastern Cooperative Oncology Group score of 0 to 3 points.
- •The organ function is intact.
- •Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤2×ULN (Upper Limit of Normal).
- •Creatinine≤2×ULN.
- •Bilirubin≤2×ULN.
- •Karnofsky≥
- •The expected survival period is at least 12 weeks.
- •Non-pregnant, non-breastfeeding women.
排除标准
- •Suffering from other untreated or unrelieved malignant tumors within 2 years.
- •Major surgery, radiotherapy, chemotherapy, biological therapy, immunotherapy, and experimental therapy were performed within 2 weeks of the first medication.
- •Suffering from any other known serious and/or uncontrolled disease (eg, uncontrolled diabetes; cardiovascular disease, including congestive heart failure New York Heart Association [NYHA] Class III or IV, 6 months patients with myocardial infarction and poorly controlled blood pressure); chronic renal failure; or active uncontrolled infection); the investigators considered unsuitable for this clinical trial.
- •Patients who are unwilling or unable to comply with the protocol.
- •Currently being treated with other systemic anti-tumor or anti-tumor research drugs.
- •Women who are pregnant or breastfeeding.
研究组 & 干预措施
VA-PD1i
Patients are treated with PD-1 inhibitor combined with venetoclax and decitabine/azacytidine.
干预措施: PD-1 inhibitor, Venetoclax, Decitabine, Azacytidine (Drug)
结局指标
主要结局
Complete minimal residual disease (MRD) Response Rate
时间窗: At the end of Cycle 2 (each cycle is 28 days)
Percentage of subjects with MRD negative or MRD \< 0.01%
MRD Response Rate
时间窗: At the end of Cycle 2 (each cycle is 28 days)
Percentage of subjects with MRD \< 0.1% detectable by multicolor flow cytometry
Complete remission rate
时间窗: At the end of Cycle 2 (each cycle is 28 days)
percentage of subjects with complete remission (CR) and incomplete hematologic recovery (CRi)
次要结局
- Relapse-Free Survival(24 months)
- Duration of response(24 months)
- Adverse events(start of treatment to 2 weeks after end of treatment)
- Overall Survival(24 months)
研究者
Xiao-Ning Gao
Chief Physician
Beijing 302 Hospital