EUCTR2019-004883-23-FR进行中（未招募）1 期
A phase I/II Study evaluating the safety and the efficacy of Human T Lymphoid Progenitor (HTLP) injection to accelerate immune reconstitution after umbilical cord blood (UCB) transplantation in adult patients with hematologic malignancies - HTLP-onco-adult
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- APHP
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
- •Adults (=18 and <55 years old) at the time of inclusion
- •High risk AML in CR1 (with t(6;9), t(v; 11q23), t(9;22), Inv(3), t(3;3), abnormalities of 3q, monosomy 5, 7, 17, complex caryotype, monosomal caryotype, FLT3-ITD (Ratio =O.5) without NPM1 mutations)
- •AML with any adverse genetic abnormality, secondary or therapy related AML excluding good risk genetic abnormalities, or any poor risk feature
- •MRD+ patients after first line chemotherapy
- •Relapsed AML in CR2
- •Absence of a matched – related sibling donor (MSD) or a matched unrelated donor (MUD) 10/10
- •SORROR score = 3
- •Presence of two UCB units with the following criteria*: HLA- matched 6/8, 7/8 or 8/8 for HLA- A, -B, and DRB1 locus, no mismatch at HLA- C locus
- •Presence of at least one UCB unit with the following criteria*: = 3 x 107 TNC/kg and = 1.5 105 CD34+/kg pre- freezing AND HLA- matched 6/8, 7/8 or 8/8 for HLA- A, -B, and DRB1 locus, no mismatch at HLA- C locus
- •* For the UCB taken into HTLP culture, the UCB with fewer CD34+ cells number will be chosen, as expansion during HTLP culture has been proven to ensure the appropriate number of CD7+ needed for each dose.
- •The non- cultured UCB will be chosen to have a higher CD34+ cell content in order to enable long- term hematopoietic engraftment
- •No prior therapy with allogeneic stem cell transplantation
- •No treatment with another investigational drug within one month before inclusion
- •Patient affiliated to social security
- •Written, informed consent of the patient
- •Are the trial subjects under 18? no
- •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 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Active disease at the time of transplantation
- •Previous allogeneic stem cell transplantation
- •Any of the standard contraindications to allogeneic transplant
- •?Left ventricular ejection fraction <50%
- •?Abnormal biochemistry results (ALT/AST>10xULN, total bilirubin>2.5xULN, creatinin clearance <60ml/min)
- •?Lung: DLCO < 50%
- •Inability to understand and provide informed consent
- •Concomitant infectious disease: HTLV-I, HIV-I or HIV-II
- •Pregnancy or breastfeeding for women of childbearing potential
研究者
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