2024-520326-11-00尚未招募2 期
Prospective Phase II study on Safety and Efficacy of Fludarabine plus Treosulfan (14g) (FT14) conditioning regimen for allogeneic Stem Cell Transplantation (allo-SCT) in Acute Myeloid Leukemia (AML) patients (≥40 <65years)
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia17 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2025年1月31日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 82
- 试验地点
- 17
- 主要终点
- The 1-year leukemia -free survival (LFS) after allo-SCT
研究概览
简要总结
To evaluate the safety and efficacy of the FT14 conditioning regimen for allo-SCT in AML patients (≥40 <65years) in complete morphological remission (CR/CRi/MLFS)
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients >40 <65 years of age
- •Diagnosis of AML in first CR/CRi/ MLFS
- •Eligible for allo-SCT from HLA-identical matched related or unrelated donor as defined by molecular high-resolution typing (4 digits) at the following four HLA gene loci (HLA-A, B, C, and DRB1)
- •Adequate hepatic function (bilirubin ≤2 UNL; ALT/AST ≤2,5 UNL)
- •Adequate renal function (creatinine clearance ≥50 ml/min)
- •ECOG Performance Status < 2
- •Willing and able to comply with all of the requirements and visits in the protocol
- •Written and signed informed consent
排除标准
- •AML patients with t(15;17); t(8;21); inv(16)
- •Participation in another clinical trial within 1 month before the start of this trial
- •Participant, both female and male, in childbearing age who do not agree to maintain active contraceptive practice
- •Pregnant or lacting patients during screening
- •Subject has known active CNS involvement with AML
- •Grade >2 NCI-CTCAE (v. 5) adverse events at the time of enrollment
- •Serious organ dysfunction: left ventricular ejection fraction < 40%, FEV1, FVC, DLCO (diffusion capacity) <40% of predicted, LFT > 5 times the upper limit of normal, or creatinine clearance < 40 ml/min
- •The evidence of HBV or HCV active infection (HBV DNA, HCV RNA positive test)
- •Patients with HIV infection
- •Current uncontrolled infections
- •Patients with other life-threatening concurrent disease
- •Subjects with known hypersensitivity to any of the component medication
结局指标
主要结局
The 1-year leukemia -free survival (LFS) after allo-SCT
The 1-year leukemia -free survival (LFS) after allo-SCT
次要结局
未报告次要终点
研究者
S.C. Clinical Trial Center
Scientific
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
研究点 (17)
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