CTRI/2021/09/036713尚未招募2 期
atural Killer(NK) Cell-based Immunotherapy for Acute Leukemia withAbatacept (CTLA4-Ig): Exploring the Crosstalk between NK cellsand Monocyte/ Macrophages. - Abatacept mediated NK cell Immunotherapy (ABANI)
Manashi Chakrabarti Foundation0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
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
入选标准
- •Â· First allogeneic transplant.
- •Â· Age between 2 and 65 years.
- •Â· Patients must have a related donor that is HLA-matched at least 5 of 10 HLA A, B, C, DRB1, DQB.
- •Â· Cardiac function: Shortening fraction >25%; ejection fraction >40%
- •Â· Estimated creatinine clearance greater than 50 mL/minute
- •Â· Pulmonary function: DLCO >=40% (adjusted for hemoglobin) and FEV1>=70%, oxygen saturation >91%
- •Â· Liver function: direct (conjugated) bilirubin < 2x the upper limit of normal and ALT/AST < 2.5x the upper normal limit
- •Â· No major organ disfunction
- •Â· Signed informed consent
排除标准
- •Â· Life expectancy less than 6 months
- •Â· Patients with uncontrolled bacterial, viral or fungal infections (undergoing appropriate treatment and with progression of clinical symptoms) within 1 month prior to conditioning. Patients with febrile illness or suspected minor infection should await clinical resolution prior to starting conditioning.
- •Â· Pregnant or breastfeeding patients
- •Â· Patients seropositive for the human immunodeficiency virus (HIV)
- •Â· Patient with active Hepatitis B or C determined by serology and/or NAAT not on treatment
- •Â· Active hepatitis, bridging fibrosis or cirrhosis on liver biopsy (biopsy required for patients on chronic transfusion therapy for > 1 year and evidence of iron overload with ferritin >1000 ng/mL)
- •Â· Patients with suitable 10/10 HLA matched related and unrelated donors
研究者
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