1. Investigational drugs: Subcutaneous Azacitidine and Durvalumab, which activates the immune system to have a response against tumor cells.
  2. For what level of MDS severity risk: High risk; also elderly patients (age ≥ 65 years) with Acute Myeloid Leukaemia
  3. What subtype of MDS: Intermediate –2 or High Risk

  4. Aims and benefits: This is a phase 2 study for previously untreated patients with higher risk MDS or elderly patients with AML who are not eligible for haemopoietic stem cell transplant.
    Durvalumab is an antibody which works against a specific cell death (PD-L1) which activates the immune system to have a response against tumor cells expressing PD-L1.
    (Monoclonal antibody directed against programmed cell death-1 ligand 1 (PD-L1) which activates the immune system to exert a response against tumor cells expressing PD-L1.
    The study aims to evaluate the Efficacy and Safety of Azacitidine (subcutaneous) in Combination With Durvalumab

      Primary outcome measures:

    • Overall response rate
      Secondary outcome measures:

    • Time to response, cytogenetic response, progression-free survival, duration of haematological response, time to AML transformation (for MDS patients)
  5. Basic inclusion criteria:
    • ECOG performance status of 0, 1 or 2
    • Central confirmation of the diagnosis of untreated MDS and of the MDS risk classification as per IPSS-R (Intermediate, High or very High risk) OR
    • Central confirmation of the diagnosis of untreated AML with intermediate or poor risk status based on cytogenetics.
  6. Basic exclusion criteria:
    • Prior haematopoietic stem cell transplant
    • Patient considered eligible for haematopoietic stem cell transplant
    • Prior exposure to Azacitidine, decitabine or exposure to the investigational oral formulation of Decitabine or other oral Azacitidine derivative
    • Significant liver or kidney impairment
    • Patients with active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease, diverticulitis with the exception of a prior episode that has resolved or diverticulosis, celiac disease, irritable bowel disease active within the last 6 months or other serious gastrointestinal chronic conditions associated with diarrhoea; systemic lupus erythematosus; Wegener's syndrome [granulomatosis with polyangiitis]; myasthenia gravis; Graves' disease; rheumatoid arthritis; hypophysitis, uveitis; etc) within the past 3 years prior to the start of treatment.
  7. Trial sites/locations and name of physician in charge of trial: 
    University Hospital Birmingham, Birmingham; St James University Hospital, Leeds; University College Hospital, London; St Bartholomews Hospital, London; Kings College Hospital, London; The Christie NHS Foundation Trust, Manchester; John Radcliffe Hospital, Oxford; The Royal Marsden NHS Foundation Trust, Sutton
  8. More information:

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