IRCT20200417047113N2招募中2 期
Evaluation of efficacy and safety of allogeneic activated Natural Killer cells in adult patients with relapsed/refractory acute myeloid leukemia.
Middle East Gene Therapy corporation0 个研究点目标入组 5 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 5
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 years 至 65 years（—）
- 性别
- All
入选标准
- •Patients with AML of both genders in the age range of 18 to 65 years with the following conditions:• Refractory AML that has not fully recovered after induction therapy.• Relapsed AML that is not a candidate for bone marrow allogeneic transplantation.• High-risk AML (based on ELN criteria) in complete remission (CR) but currently not a candidate for allogeneic bone marrow transplantation.• Relapsed AML after bone marrow transplantation
- •Patients with known CNS involvement with AML provided that they had been treated and the CSF was clear for at least 2 weeks prior to study enrollment
- •ECOG performance status less than or equal to 2
- •Adequate performance of organs as follows:•Total bilirubin = 2 mg/dL•AST(SGOT)/ALT(SGPT) = 3.0 x IULN•Creatinine within normal institutional limits OR creatinine clearance = 50 mL/min/1.73 m2 by Cockcroft-Gault Formula (adults) or Schwartz formula (pediatric cohort)•Oxygen saturation =90% on room air•Ejection fraction =50%
- •Be able to stop using corticosteroids and other immunosuppressive drugs from day 3- the beginning of the trial and up to 30 days after the injection of NK cells. However, if clinically necessary, the use of low-level corticosteroids is allowed. Low-level corticosteroid use was defined as 10 mg or less of prednisone (or equivalent for other steroids) per day
- •Not pregnant or breastfeeding
- •Failure to receive any research drug within 14 days before the start of the clinical trial
- •Ability to understand and willingness to sign a certified informed consent document (or if there is an authorized legal representative)
排除标准
- •Uncontrolled bacterial or viral infections, or known HIV, hepatitis B or C infection
- •Uncontrolled angina, severe uncontrolled ventricular arrhythmias, or EKG indicating acute ischemia or active conduction system abnormalities
- •New progressive pulmonary infiltrates on screening chest x-ray or chest CT scan that were not evaluated by bronchoscopy. Infiltrations attributed to infection should be stable and improving after 1 week of appropriate therapy (4 weeks for suspected or proven fungal infections)
- •Known sensitivity to one or more study agents
- •Active autoimmune disease that requires systemic immunosuppression treatment
- •Known history of other cancers in the last 5 years
研究者
相似试验
招募中
不适用
Safety and efficacy of Mesenchymal Stem Cell administration in Bronchiolitis Obliterans Syndrome.IRCT20201202049568N2Tehran University of Medical Sciences10
招募中
1 期
Effect of NK cell therapy in COVID-19IRCT20200417047113N1Middle East Gene Therapy corporation70
已完成
1 期
Evaluation of the safety and efficacy of allogenic hematopoietic stem cell transplantation (HSCT) from HLA-mismatched related donors using alemtuzumab in patients with hematological malignancies.Hematological malignanciesJPRN-C000000357GCP-ISS HE0402 group48
尚未招募
1 期
Assessment of the effect of allogeneic adipose derived mesenchymal stem cells along with platelet rich fibrin for perianal fistulas in treatment of perianal fistulasperianal fistula.Fistula, other specified siteM25.18IRCT20210830052332N1Iranian academic center for education culture and research24
招募中
1 期
Evaluation of the safety and efficacy of allogeneic activated Natural killer cells in metastatic Colon AdenocarcinomaIRCT20230704058675N1Middle East Gene Therapy corporation10