RBR-8qq5h9尚未招募1 期
Phase I/II clinical trial with expanded ex vivo Natural Killer (NK) cells to treat Acute Myeloid Leukemia (AML) - NKCAML: Natural Killer Cells for Acute Myeloid Leukemia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Intervention
入排标准
- 年龄范围
- 3Y 至 75Y（—）
入选标准
- •Patients with relapsed acute myelogenous leukemia, including CNS diseases or previous hematopoietic stem cell transplantation, who have failed remission for at least one cycle of standard or experimental re-induction chemotherapy or primary refractory AML (primary AML failed to achieve remission after at least two cycles of induction therapy); Patient with high risk AML or MDS without donor for allogeneic transplantation available at the time of therapy; Patients with performance status ? 2 on Zubrod scale (ECOG) or Lansky 60; Organic function with respiratory capacity 50%, pulmonary symptoms controlled by medication and pulse oximetry greater than or equal to 92%; Creatinine ?2 mg / dL for adults, ?2 mg / dL or ?2 the upper limit of normal for age for children, or with creatinine clearance ?60 mL / min / 1.73 m2; Total bilirubin ? 2 mg / dL or TGP (ALT) <2.5 x ULN for age (unless Gilbert's disease or abnormal liver function due to primary disease); Classification New York Heart Association> III; Negative pregnancy test for women of childbearing age (non-fertile age defined as pre-menarche, post-menopausal over one year, or surgically sterilized); Acceptance of the use of contraceptive methods by sexually active men and women of childbearing age; Patient should have recovered from the toxicity related to previous treatment of cytotoxic agents received within 4 weeks before starting treatment in this protocol (with the exception of cytopenias resulting from persistent disease and alopecia)
排除标准
- •Patients with high-risk AML and MDS with active, HIV-positive hepatitis B or C; With liver cirrhosis; Uncontrolled infections; Female patients with positive pregnancy test; Congestive heart failure <6 months before screening; Unstable breast angina <6 months before selection; Myocardial infarction <6 months before selection; Non-signing free and informed consent term
研究者
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