EUCTR2018-001076-38-FR进行中（未招募）1 期
A Phase III Randomized, Double-Blind Trial to Evaluate the Efficacy of Uproleselan Administered with Chemotherapy versus Chemotherapy Alone in Patients with Relapsed/Refractory Acute Myeloid Leukemia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 380
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •The most important inclusion criteria are::
- •=18 years and =75 years in age
- •Patients with relapsed or refractory AML
- •No more than one prior stem cell transplant
- •Has not received the chemotherapy regimen to be used for induction on this trial
- •Is considered medically eligible to receive the chemotherapy regimen to be used for induction on this trial
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 280
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •The most important exclusion criteria are:
- •Patients with acute promyelocytic leukemia, acute leukemia of ambiguous lineage (biphenotypic leukemia), chronic myeloid leukemia with myeloid blast crisis, or secondary refractory AML
- •Active signs or symptoms of CNS involvement by malignancy
- •Stem cell transplantation =4 months prior to dosing
- •Any immunotherapy or radiotherapy within 28 days of dosing; any other experimental therapy or chemotherapy within 14 days of dosing
- •Prior use of G-CSF, CM-CSF or plerixafor within 7 days of dosing
- •Inadequate organ function
- •Abnormal liver function
- •Known active infection with hepatitis A, B, or C, or human immunodeficiency virus
- •Moderate kidney dysfunction (glomerular filtration rate <45 mL/min)
- •Uncontrolled acute life-threatening bacterial, viral, or fungal infection
- •Clinically significant cardiovascular disease
- •Major surgery within 4 weeks of dosing
研究者
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