EUCTR2019-003362-41-IT进行中（未招募）1 期
Phase I/IIa clinical trial on the safety and preliminary efficacy of donor-derived anti-leukemia cytotoxic T lymphocytes for the prevention of leukemia relapse in children given haploidentical hematopoietic stem cell transplantation - Anti-leukemia T cell therapy after haplo-HSCT
FONDAZIONE I.R.C.C.S. POLICLINICO SAN MATTEO0 个研究点目标入组 15 人开始时间: 2020年10月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Age inferior or equal to 18 years and superior or equal to 1 months
- •2) Life expectancy > 12 weeks
- •3) Patients affected by life-threatening acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML) with high risk of relapse after HSCT, namely:
- •Patients affected by ALL:
- •- in first morphological remission but with a positive minimal residual disease = 1 x 10-3 before HSCT;
- •- in second morphological remission after a high-risk relapse (patients belonging to the S3-S4 BFM risk group), independently of the level of minimal residual disease;
- •- in second morphological remission with any positivity of minimal residual disease before HSCT;
- •- in third or subsequent morphological remission, independently of the level of minimal residual disease;
- •- patients not in morphological remission at time of HSCT.
- •Patients affected by AML:
- •- in first morphological remission and with a flow cytometry MRD at the end of induction therapy = 0.1%;
- •- in first morphological remission and with high-risk disease according to cytogenetics aberrations;
- •- in first morphological remission after a primary induction failure;
- •- in second morphological remission;
- •- in third or subsequent morphological remission;
- •- patients not in morphological remission at time of HSCT.
- •4) Pre-HSCT Lansky / Karnofsky score = 40%.
- •5) HIV negativity.
- •6) Written informed consent signed by the parents or legal guardians (in case of patients < 18 years) or by the patients (in the case of patients = 18 years).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 2
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Ongoing active superior or equal to grade II acute GvHD or chronic extensive GvHD due to a previous allograft
- •2) Current clinically active infectious disease (including positive HIV serology or viral RNA)
- •3) Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or left ventricular ejection fraction <40%)
- •4) Liver dysfunction (AST/ALT superior or equal to 3 times institutional upper limit normal value –ULN- or bilirubine > 3 times ULN)
- •5) Renal dysfunction: serum creatinine > 1.5 times ULN or calculated creatinine clearance < 60 ml/min/1.73 m2
- •6) End stage irreversible multi-system organ failure.
- •7) Other active malignancy.
- •8) Pregnant or breast feeding female patient
- •9) Lack of parents’/guardian’s written informed consent for minors or lack of written informed consent for patients aged 18 y.
研究者
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