NCT03616470终止3 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
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 388
- 试验地点
- 70
- 主要终点
- Overall survival
研究概览
简要总结
This study will evaluate the efficacy of uproleselan (GMI-1271), a specific E-selectin antagonist, in combination with chemotherapy to treat relapsed/refractory AML, compared to chemotherapy alone. The safety of uproleselan when given with chemotherapy will also be investigated in patients with relapsed/refractory AML
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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
排除标准
- •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 therapy 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.
研究组 & 干预措施
Uproleselan (GMI-1271)
Experimental
Uproleselan in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI)
干预措施: Uproleselan (Drug)
Placebo (Saline, 0.9% Sodium Chloride)
Placebo Comparator
Placebo in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI)
干预措施: Placebo (Drug)
结局指标
主要结局
Overall survival
时间窗: 5 years
Time from the date of randomization into the study to the date of death.
次要结局
- Overall response rate(Up to 60 days)
- Rate of severe oral mucositis(up to 60 days)
研究者
研究点 (70)
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