Last updated on February 2018

Infection and Tumour Antigen Cellular Therapy

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Acute myeloid leukemia
  • Age: Between 1 - 70 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Patients undergoing myeloablative or non-myeloablative allogeneic transplantation from an HLA (A, B and DR) identical or 1-3 antigen mismatched family or unrelated donor
  2. Transplant performed for acute myeloid leukaemia
  3. Leukaemia blasts express the WT1 tumour antigen as determined by the European LeukaemiaNet standardised assay described in 16. WT1 overexpression will be defined by greater than 250 copies/104ABL copies in bone marrow samples or greater than 50 copies/104ABL copies in peripheral blood. This assay will be performed on samples collected as part of routine clinical care at diagnosis and during initial treatment prior to transplantation. Testing will be performed after consent for trial participation has been obtained and negativity for WT1 will be classified as screening failure
  4. Recipients of peripheral blood HSCT
  5. Adequate hepatic and renal function (< 3 x upper limit of normal for AST, ALT, < 2 x upper limit of normal for total bilirubin, serum creatinine)
  6. Estimated life expectancy of at least 12 months
  7. Patient (or legal representative) has given informed consent

Exclusion Criteria:

  1. Use of anti-lymphocyte globulin (ALG, ATG, Campath or other broad spectrum lymphocyte antibody) given in the 4 weeks immediately prior to infusion or planned within 4 weeks after infusion
  2. Grade II or greater graft versus host disease within 1 week prior to infusion
  3. Prednisone or methylprednisone at a dose of > 1 mg/kg (or equivalent in other steroid preparations) administered within 72 hours prior to cell infusion
  4. Prior allogeneic HSCT
  5. Privately insured in or outpatients (see Indemnity Issues, Section 11.4)

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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