EUCTR2024-000261-24-Outside-EU/EEA进行中（未招募）1 期
A Phase I/II Open-Label Study of ECT-001-Expanded Cord Blood Transplantation in pediatric and young adult (<21year) Patients with High-Risk and Very High-Risk Myeloid Malignancies (ECT-001-CB.007)
Cordex Biolohics Inc0 个研究点开始时间: 2024年6月24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
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)Acute Myeloid Leukemia
- •a)Chemo-refractory relapse (MRD+)
- •b)Primary induction failure (no CR or CRi after >= 2 courses of intensive induction therapy): < 30% blasts in evaluable marrow.
- •c)Relapse after previous allogeneic (or autologous) transplant (Note: ECB-001-CB transplant to take place > 4 months from previous transplant)
- •d)Secondary or therapy-related MDS/AML
- •e)Poor response to induction (5-30% blasts) or MRD+ after induction
- •2)Myelodysplastic syndrome (MDS)
- •a)Relapse after allogeneic or autologous transplant (Note: ECB-001-CB transplant to take place >4 months from previous transplant)
- •b)=10 % blasts within 30 days of start of conditioning regimen
- •c)Poor and very poor cytogenetics abnormalities and very high-risk molecular abnormalities (e.g., TP53)
- •3)Chronic myelogenous leukemia: Patients with history of blast crisis or accelerated phase
- •4)Mixed Phenotype Acute Leukemia: MRD+ or relapse after previous transplant (>4 months).
- •5)JMML (Juvenile Myelo-Monocytic Leukemia)
- •6)0 – 21 years
- •7)Availability of 2 = 4/8 HLA matched CBU (allele level: A, B, C and DRB1)
- •a)Cord to be expanded: CD34+ cell count = 0.5 x 10E5/kg and TNC = 1.5 x 10E7/kg (pre-cryo)
- •b)Back up cord: Pre-freeze TNC = 2 x 10E7/kg with CD34+ cells = 1 x 10E5/kg. If a single cord does not meet this criterion 2 back up cords will be an acceptable alternative with a minimum for each of 1.5 x 10E7 TNC/kg and 1 x 10E5/kg CD34+ cells. Another acceptable HSC back up source could be a haploidentical with medical clearance prior to starting conditioning regimen.
- •7)Lansky / Karnofsky >60%
- •8)Bilirubin < 2 x upper limit of normal (ULN) unless felt to be related to Gilbert’s disease or hemolysis; AST and ALT < 3 x ULN; alkaline phosphatase < 5 x ULN
- •9)Estimated or measured creatinine clearance = 50 ml/min/1.73m2
- •10)Left ventricular ejection fraction of = 40%
- •11)FVC, FEV1 and DLCO (corrected for hemoglobin) >= 50% of predicted. In young children unable to perform pulmonary function testing: pulse oximetry >92% in room air and a normal CT of the chest
- •12)Signed written informed consent (parents or legal guardians for minor patients).
- •13)Female patients of childbearing potential must have a negative serum pregnancy test within 7 days of enrolment and mush be willing to use an effective contraceptive method while enrolled in the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 15
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1)Previous allogeneic transplantation within 4 months.
- •2)Uncontrolled infection.
- •3)Presence of other malignancy other than the one for which the CB transplant is being performed, with an expected survival to be less than 75% at 5 years
- •4)Seropositive for HIV.
- •5)Hep B and C infection with measurable viral load.
- •6)Liver cirrhosis.
- •7)Active CNS disease.
- •8)Chloroma > 2cm.
- •9)>30% blasts in marrow in evaluable marrow sample.
- •10)Pregnancy, breastfeeding or unwillingness to use appropriate contraception
- •11)Participation in a trial with an investigational agent within 20-30 days prior to the date of transplant (infusion of the expanded CD34+ cells): for investigation agents with half-life < 1 day: patient must be off the Investigational agent for 20 days; for investigation agents with half-life > 1 day: patient must be off the Investigational agent for 30 days.
- •12)No signed informed consent.
- •13)Any abnormal condition or lab result that is considered by the PI capable or altering patient’s condition or study outcome.
研究者
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