1. Name of trial drug: Decitabine
  2. For what level of MDS severity risk: Intermediate 2 or High Risk
  3. What subtype of MDS: MDS with 5% or more marrow blasts or chronic myelomonocytic leukemia (CMML-2); or AML with 20-30% bone marrow blasts
  4. Aims and benefits: This trial investigates whether Decitabine has a good response rate in MDS patients who failed therapy with Azacitidine

  1. Main Aims: Overall response rate in the efficacy-evaluable (EE) population - over 6 months
    Secondary aims:
    Overall survival (over 18 months)
    How well the drug works to slowdown progression to AML (for MDS and CMML-2 patients only)
    Haematological improvement
    Transfusion requirements
    Cytogenetic response
    Treatment related toxicity
  2. Main basic inclusion criteria: Patients who failed therapy with Azacitidine. Age over 18
  3. Main basic exclusion criteria:
    1. Nursing and pregnant females.
    2. Females of childbearing potential and males not willing to practice an effective method of contraception whilst receiving decitabine and for 2 months after the last infusion.
    3. Patients with previous malignancy or concurrent malignancy.
    4. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure and unstable angina pectoris.
    5. Ongoing oral corticosteroids are not permitted. However, use of corticosteroids (topical and inhaled) is permitted and prophylactic steroids are allowed for transfusion reactions.
    6. Patients who have received any investigational agent within the 30 days preceding the first dose of study drug.
    7. Patients who have received prior intensive combination chemotherapy (Prior biologic therapies, targeted therapies and single agent chemotherapy are allowed).
    8. Patients who have an active viral or bacterial infection. Note: No patient is allowed to enter the study unless infections have been fully treated and the patient has remained afebrile for 7 days without antibiotics.
    9. Patients who have concurrent autoimmune hemolytic anemia or immune thrombocytopenia.
    10. Patients who have previously been treated with decitabine.
    11. Patients who have known positive serology for HIV.
    12. Patients with a condition that may be unable to comply with the treatment and monitoring requirements of the study.
  4. Trial sites/locations and name of physician in charge of trial: King’s College London UK
  5. More information: https://clinicaltrials.gov/ct2/show/NCT01133886

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