NL-OMON54661招募中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 - Trial to assess Uproleselan vs Chemo Alone in Patients with R/R AM
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Inclusion Criteria:
- •1. >=18 years and <=75 years in age
- •2. Patients with relapsed or refractory AML
- •3. No more than one prior stem cell transplant
- •4. Has not received the chemotherapy regimen to be used for induction on this
- •5. Is considered medically eligible to receive the chemotherapy regimen to be
- •used for induction on this trial
- •6. Written informed consent
排除标准
- •Exclusion Criteria:
- •1. Patients with acute promyelocytic leukemia, acute leukemia of ambiguous
- •lineage (biphenotypic leukemia), chronic myeloid leukemia with myeloid blast
- •crisis, or secondary refractory AML.
- •2. Active signs or symptoms of CNS involvement by malignancy.
- •3. Stem cell transplantation <=4 months prior to dosing.
- •4. Any immunotherapy or radiotherapy within 28 days of dosing; any other
- •experimental therapy or chemotherapy within 14 days of dosing.
- •5. Prior use of G-CSF, CM-CSF or plerixafor within 7 days of dosing.
- •6. Inadequate organ function.
- •7. Abnormal liver function.
- •8. Known active infection with hepatitis A, B, or C, or human immunodeficiency
- •9. Moderate kidney dysfunction (glomerular filtration rate <45 mL/min).
- •10. Uncontrolled acute life-threatening bacterial, viral, or fungal infection.
- •11. Clinically significant cardiovascular disease.
- •12. Major surgery within 4 weeks of dosing.
研究者
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