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):

  1. Follicular lymphoma or Lymphoplasmacytic lymphoma or
  2. HLA-identical sibling transplant to be performed using the fludarabine-melphalan-alemtuzumab conditioning regimen Small Cell Lymphocytic Lymphoma/CLL and beyond 1st line therapy
  3. Aged ≥18 years, and <70 years
  4. Written informed consent

Exclusion criteria

  1. Histological evidence of high-grade ProT4 Trial Summary & Flowchart v1.0 23.02.11 transformation
  2. Pregnant or lactating women
  3. Life expectancy of <8 weeks
  4. Currently taking part in any other interventional clinical research study (involving any IMP, ATMP or cellular therapy)
  5. Organ dysfunction: Creatinine >200μmol/l, />Bilirubin >50μmol/l, or AST/ALT > 3x ULN Post-transplant
  6. Active acute GvHD
  7. Prior grade II-IV GvHD
  8. Relapse or progressive disease
  9. Primary or secondary graft failure
  10. Other cellular therapies
  11. 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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