RFUSIN2-AML1

 Acute myeloid leukaemia / Posted 1 year ago

This trial is looking at a new vaccine made by altering people’s own donated leukaemia cells and injecting them back to trigger their immune system. You have the vaccine with the standard treatment of having white blood cells through a drip into a vein.

  • Inclusion Criteria :
    • Have AML that came back after you had a transplant with a lower dose of chemotherapy and donated stem cells (a reduced intensity conditioning donor stem cell transplant)
    • Still have some leukaemia cells in your body after your transplant
    • Had more CD3 markers from your donor than made by your own body when your AML came back – you can ask you doctor more about this
    • Agree to the trial team collecting and storing your newly developing AML cells (AML blasts)
    • Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
    • Are at least 18 years of age
    • You have already had chemotherapy to treat AML that came back after transplant
    • The chemotherapy reduced the number of developing AML cells (blasts) in your bone marrow to less than 5 in 100 (5%)
    • You have satisfactory blood test results
    • You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
    • You are willing to use reliable contraception throughout the trial if there is a chance that you or your partner could become pregnant
    • You are at least 18 years of age
  • Exclusion Criteria :
    • You will not be able to enter this trial if your AML has come back but you
    • Are not well enough to have chemotherapy
    • Have any other cancer apart from an early cancer called carcinoma in situ that has been successfully treated
    • Have HIV
    • You will not be able to enter this trial if you have had chemotherapy to treat AML that came back
    • Have a condition where the cells from your stem cell transplant are attacking your own cells (Graft versus Host Disease or GvHD)
    • Are having other types of treatment for your AML
    • Have any other cancer apart from an early cancer called carcinoma in situ
    • Have a heart condition that is a cause for concern
    • Are pregnant
    • Have HIV, Hepatitis B or Hepatitis C
  • Study start date : 27/07/2009
  • Study end date : 01/08/2021
  • Wales-Based Study Contact : Not recruiting in Wales
  • Principal Investigator : Professor G Mufti

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