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


Research Nurse Transplant

Anne Ewing

Tel: 0113 2067404


Other trials currently active for Transplant

book icon


A Randomised Trial of the FLAMSA-BU CondItioning ReGimen in Patients with Acute Myeloid Leukaemia and Myelodysplasia UndeRgoing AllOgeneic Stem Cell Transplantation

book icon

UK Haplo

A UK multicentre phase II study of haploidentical stem cell transplantation in patients with haematological malignancies

book icon

Genetic Factors MUD

Genetic factors affecting the outcome of unrelated stem cell transplantation. Primary Objective: To identify a significant correlation between genetic factors found in the donor or the recipients blood and transplant outcome. Secondary Objectives: To maintain a database of genetic typing to supplement the existing database kept by the registry

book icon


LenaRIC – Phase II study of the adjunctive use of Lenalidomide in patients undergoing reduced intensity conditioning allogenic transplantation for multiple myeloma.