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Trial Details
Trial status:
Active (recruiting)
Recruitment start date:
03/01/2020
Funder:
MRC
Sponsor:
UCL
Chief Investigator:
Professor Ronjon Chakraverty
Recruitment target:
18
EudraCT number:
N/A
Contact details:
ctc.totem@ucl.ac.uk
Lay summary:
ToTem
Phase I study of transfer of effector memory T cells (Tem) following allogeneic stem cell transplantation
Description
Design:
ToTem is a national phase I trial studying the transfer of effector memory T cells (Tem) in patients eligible for allogeneic stem cell transfer.  A Bayesian Time-to-Event Continual Reassessment Method (CRM) will be used to determine the safety and maximum tolerated dose (MTD) of the Tem cells, CD62L- Tem.  

Treatment: Eligible patients and HLA-identical sibling donors will be registered prior to transplant, and the donors will undergo an additional steady state apheresis for the collection of T cells and selection of the Tem cells.  The donor Tem cells, at the required dose, will be given as a single infusion between day 24-32 following the allo-SCT, and patients closely followed up for up to 72 days post the infusion. They will also have regular visits at 3, 6, 9 and 12 months following allo-SCT.
Key inclusion/exclusion criteria: Patients must be from 16 to less than 70 years of age with a diagnosis of either Severe aplastic anaemia, Primary immune deficiency or a Haematological cancer with a complete or partial response/remission, suitable for HLA-identical sibling transplant using a standard alemtuzumab-based conditioning regimen with calcineurin-inhibitor based immunoprophylaxis. They must not have prior or active acute pattern GvHD of any grade, or a primary/secondary graft failure.
Duration of recruitment: Anticipated 30 months recruitment and a minimum of 12 months post-STC.   So the study is expected to last at least 3 years.
Aim
To determine the feasibility and safety of the transfer of donor Tem cells following allogeneic stem cell transplantation.
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
NameVersionCurrent versRelease dateDownload
2_ToTem_Protocol_v2_270320_Clean_07072021_0.pdf2 Current 27/03/2020
Trial documents
No documents have been currently made available for download
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