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ProT4
Trial Overview
Prophylactic Transfer of CD4 Lymphocytes (ProT4) A 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 cancer
Inclusion criteria
At registration (pre-transplant):
- Follicular lymphoma or Lymphoplasmacytic lymphoma or
- HLA-identical sibling transplant to be performed using the fludarabine-melphalan-alemtuzumab conditioning regimen Small Cell Lymphocytic Lymphoma/CLL and beyond 1st line therapy
- Aged ≥18 years, and <70 years
- Written informed consent
Exclusion criteria
- Histological evidence of high-grade ProT4 Trial Summary & Flowchart v1.0 23.02.11 transformation
- Pregnant or lactating women
- Life expectancy of <8 weeks
- Currently taking part in any other interventional clinical research study (involving any IMP, ATMP or cellular therapy)
- Organ dysfunction: Creatinine >200μmol/l, />Bilirubin >50μmol/l, or AST/ALT > 3x ULN Post-transplant
- Active acute GvHD
- Prior grade II-IV GvHD
- Relapse or progressive disease
- Primary or secondary graft failure
- Other cellular therapies
- Requirement for ongoing immunosuppression
Consultant Haematologist
Dr Maria Gilleece
Tel: 0113 2067956 / 2068433
E-mail: maria.gilleece@leedsth.nhs.uk
Research Nurse Transplant
Anne Ewing
Tel: 0113 2067404
E-mail: anne.ewing@leedsth.nhs.uk

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