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Trial Details
Trial status:
In follow-up (non-recruiting)
Recruitment start date:
Leukaemia & Lymphoma Research
Chief Investigator:
Dr Ronjon Chakraverty
Recruitment target:
54 randomised patients
EudraCT number:
Contact details:
Lay summary:
Multicentre randomised phase II study to evaluate the efficacy of prophylactic transfer of CD4 lymphocytes after T-cell depleted reduced intensity HLA-identical sibling transplantation for haematological cancers
Design: ProT4 is a multicentre, randomised phase II trial to evaluate the efficacy of prophylactic transfer of donor CD4 lymphocytes after T-cell depleted reduced intensity allogeneic transplantation for haematological cancers using cells from an HLA-identical sibling donor.
Treatment: Patients will be registered prior to transplant, which will use a reduced intensity alemtuzumab-containing conditioning regimen and cells from a matched sibling donor. Patients will be re-assessed 2-3 months post-transplant to assess eligibility for randomisation. Eligible patients will be randomised at a 2:1 ratio to either a single infusion of CD4 DLI 3-4 months post-transplant, or no further treatment. Patients are followed up 3 monthly for 1 year, and annually thereafter.
Key inclusion/exclusion criteria: Patients must be aged 18 or over, and having a stem cell transplant with alemtuzumab-containing conditioning for a haematological cancer (leukaemia, lymphoma, myeloma or myelodysplastic syndrome) using cells from an HLA-identical sibling donor. The patient must be in at least partial remission and be fit for transplant. In order to be randomised, patients cannot have active acute GvHD of any grade or progressive disease. They cannot have had prior grade II-IV GvHD or graft failure, and systemic immunosuppressive therapy must have been withdrawn. Donors should meet transplant centre criteria regarding suitability for cell therapy donation and be willing to have a second apheresis if the patient is randomised to have CD4 DLI.
Duration of recruitment: 6 years
The aim of the ProT4 trial is to investigate whether prophylactic transfer of donor CD4 cells to patients of allogeneic HSCT undergoing treatment for haematological cancers improve progression-free survival and immune reconstitution. The study will also investigate rates of infection and graft versus host disease. 
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.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
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