Adoptive Immunotherapy with CD25/71 allodepleted donor T cells to improve immunity after unrelated donor stem cell transplant (ICAT) - Immunotherapy with CD25/71 Allodepleted T-cells (ICAT)

niversity College London0 个研究点目标入组 24 人开始时间: 2014年1月29日最近更新: 2020年7月13日

适应症

试验速览

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•Patient inclusion criteria:
•1. Age =16 years
•2. Underlying acute myeloid or acute lymphoblastic leukaemia
•3. Planned allogeneic peripheral blood stem cell transplantation from a 9/10 or 10/10 HLA-matched unrelated donor, using an Alemtuzumab-based conditioning protocol
•4. Written Informed consent
•Donor inclusion criteria:
•1. Donors must be unrelated to and HLA-matched (10/10) or a single antigenic/allelic mismatch with the recipient (9/10)
•2. Donors must be healthy and pass a medical examination determining they are fit to donate peripheral blood stem cells
•3. Donors must sign an informed consent form indicating that they are aware their additional donation of peripheral blood or leucapheresis is for research purposes
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 4
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•Patient exclusion criteria:
•1.Life expectancy < 6 weeks
•2. Female patients who are pregnant and lactating
•3. Patients who are serologically positive for Hepatitis B, C or HIV pre-SCT
•Donor exclusion criteria:
•1. Donor registry determines contraindication to donate mobilised peripheral blood stem cells, 500ml peripheral blood draw or unstimulated leucapheresis for generation of PBMC.

发起方

niversity College London