1. Name of trial drug: Novel conditioning regimen: fludarabine/cytarabine/amsacrine/busulphan/ATG (FLAMSA-BU)
  2. For what level of MDS severity risk: Intermediate – 2 or High Risk
  3. What subtype of MDS: Patients with AML and MDS undergoing reduced intensity conditioning (RIC) allogeneic stem cell transplantation (SCT)
  4. Aims and benefits: This is a randomised controlled trial comparing the novel conditioning regimen FLAMSA-BU with standard conditioning regimens fludarabine/melphalan/alemtuzumab (FMA), fludarabine/busulphan/alemtuzumab (FBA) or fludarabine/busulphan/ATG (FB-ATG).
    • It compares the benefits in terms of toxicity, disease relapse and overall survival.
  5. Basic inclusion criteria:
    • Patients with AML or MDS in whom a RIC allograft is clinically indicated.
    • ECOG performance status of 0, 1 or 2
  6. Basic exclusion criteria:
    • Patients with chemo-refractory relapse of AML or MDS
    • Patients with contraindications to receiving RIC allogeneic SCT
    • Female patients who are pregnant or breastfeeding.
    • Kidney or liver impairment
    • Patients with active infection, HIV-positive or chronic active Hep-A, -B, -C
    • Patients with concurrent active malignancy
  7. Trial sites/locations and name of physician in charge of trial: QEH, Birmingham; Churchill Hospital, Oxford; Addenbrookes, Cambridge; St James’, Leeds; Bristol Haematology and Oncology Centre; Manchester Royal Infirmary; Leicester Royal Infirmary; Royal Liverpool University Hospital; Imperial ; West of Scotland Beatson Cancer Centre; Nottingham City Hospital; Aberdeen Royal Infirmary; UCLH ; Sheffield; Derriford; King’s College Hospital.
  8. More information:

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