NCT07511062尚未招募1 期
Axatilimab Combined With Decitabine/Venetoclax for the Treatment of TP53-mutated/Deleted AML Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Phase 2 Dose Level determination
研究概览
简要总结
Axatilimab combined with Decitabine/Venetoclax for the treatment of TP53-mutated/deleted AML patients
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
- •MDS/AML or AML with a TP53 mutation or deletion, defined as:
- •greater than or equal to 10% AND (one of the following):
- •presence of a TP53 mutation
- •presence of a TP53 deletion by FISH
- •positive TP53 staining on IHC of diagnostic bone marrow
- •Either untreated or first salvage (primary refractory or first relapse)
排除标准
- •active uncontrolled infection
- •history of HIV or active HBV or HBC infection
- •currently active second malignancy
- •calculated CrCl <40mL/min
- •AST and/or ALT and/or direct bilirubin >3x ULN
- •cardiac ejection fraction <40% or history of uncontrolled cardiac arrhythmias
- •history of acute or chronic pancreatitis, history of myositis
- •known leukemia involvement of CNS
- •hematopoietic stem cell transplantation within 3 months of treatment start and/or persistent non-hematologic toxicities of Grade 2+ related to the transplant
- •active acute or chronic GVHD requiring immunosuppressive treatment
研究组 & 干预措施
Axatilimab+Decitabine+Venetoclax
Experimental
干预措施: Venetoclax (Drug)
Axatilimab+Decitabine+Venetoclax
Experimental
干预措施: Decitabine (Drug)
Axatilimab+Decitabine+Venetoclax
Experimental
干预措施: Axatilimab (Drug)
结局指标
主要结局
Phase 2 Dose Level determination
时间窗: 1 year
To find the recommended phase 2 dose (RP2D) of axatilimab when combined with decitabine and venetoclax by recording adverse events based on the CTCAE v.5.
Estimation of MRD-negative complete remission
时间窗: 2 months
To estimate the MRD-negative complete remission rate after 1-2 cycles of induction chemotherapy with decitabine and venetoclax by conducing bone marrow biopsies and disease response assessments after induction
次要结局
- Estimation of Response Rates, Overall Survival(1 year)
- Evaluation of Safety of the Regimen(1 year)
- Estimation of Progression Free Survival(1 year)
- Estimation of Overall Survival(1 year)
研究者
研究点 (1)
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