Oral Azacitidine Plus Best Supportive Care


  1. SUB-TYPE OF MDS: Those who need red blood cell transfusions
  3. NAME OF DRUG: Oral Azacitidine
  4. Aims and benefits: To investigate the efficacy and safety of Oral Azacitidine + Best Supportive Care VERSUS Placebo + Best Supportive Care

  1. Specifically for: Red blood cell transfusion dependant MDS patients with low platelet counts

    How: Oral azacitidine 300mg daily (or placebo) + normal best supportive care

    Main aims and benefits:

    • efficacy and safety of Oral Azacitidine + Best Supportive Care vs Placebo +Best Supportive Care
    • Achieve red blood cell (RBC) transfusion independence

    Secondary aims:
    - Clinically significant bleeding events
    - Platelet transfusion independence and duration
    - RBC transfusion independence and duration
    - Health-related quality-of-life
    - Healthcare resource utilization
    - Hematologic response
    - Number of patients alive
    - Number of subjects with adverse events
    - Progression to acute myeloid leukemia (AML)

    Pharma company:    Celgene Corporation

  2. Main basic inclusion criteria:
    - 18 years or older
    - Diagnosis of MDS
    - Anemia that requires red blood cell transfusions
    - Thrombocytopenia (sustained for at least 21 days) within 14 days prior to trial
    - Have an ECOG performance status of 0, 1, or 2 (how active you are)
    - Must be willing to consent to two or more bone marrow aspirate procedures to be completed during study.
  3. Main basic exclusion criteria:
    - Secondary MDS or other subtype with eligibility for treatment with immunotherapy
    - Prior treatment with azacitidine, decitabine, other hypomethylating agents and lenalidomide
    - Prior allogeneic or autologous stem cell transplant
    - see further exclusion criteria on the detailed information link
  4. Trial sites/locations and name of physician in charge of trial:
    Aberdeen Royal Infirmary Aberdeen, United Kingdom, AB25 2ZN
    Birmingham Heartlands Hospital Birmingham, United Kingdom, B9 5SS
    Bristol Haematology and Oncology Centre Bristol, United Kingdom, BS2 8ED
    Addenbrookes Hospital Cambridge, United Kingdom, CB2 0QQ
    University Hospital of Wales - Cardiff Cardiff, United Kingdom, CF14 4XW
    Northwick Park Hospital Harrow Middlesex, United Kingdom, HA1 3UJ
    Queens Centre for Oncology & Haematology Hull, United Kingdom, HU16 5JQ
    Leicester Royal Infirmary Leicester, United Kingdom, LE1 5WW
    Royal Liverpool University Hospital, Prescot Street - Liverpool, United Kingdom, L7 8XP (Recruitment completed)
    Barts and The London NHS Trust London, United Kingdom, EC1A 7BE
    Guy's and St Thomas' Hospital - London London, United Kingdom, SE1 9RT
    Manchester Royal Infirmary Manchester, United Kingdom, M13 9WL
    Nottingham City Hospital - Dept of Haematology Nottingham, United Kingdom, NG5 1PB
    John Radcliffe Hospital Oxford, United Kingdom, OX3 9DU
    Kings Mill Hospital Sutton in Ashfield, United Kingdom, NG17 4SL
    New Cross Hospital Wolverhampton, United Kingdom, WV10 0QPAvailable also in: Australia, Belgium, Brazil, Canada, Czech Republic, Denmark, Finland, France, Germany, Israel, Italy, Mexico, Netherlands, Norway, Poland, Portugal, Spain, Sweden, United Kingdom, United States
  5. More information: https://clinicaltrials.gov/show/NCT01566695

Please read information and always discuss trial information with your own physician.

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