Eltrombopag for MDS patients

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  1. SUB-TYPE OF MDS: MDS patients who are platelet transfusion dependent
  2. SEVERITY OF MDS: intermediate 1 & 2 or high risk
  3. NAME OF DRUG: Eltrombopag, Promacta™/Revolade™
  4. Aims and benefits: Study will assess the proportion of patients who are platelet transfusion free during the first four cycles of treatment

  1. For: Platelet transfusion dependant MDS patients.

    IPSS: Intermediate-1, intermediate-2 or high risk patients with MDS

    How: Phase III study - eltrombopag + azacitidine vs placebo + azacitidine
    Eligible patients will be randomised to receive either option - for at least 6 cycles:

    - eltrombopag (200 mg once daily) + azacitidine
    - placebo plus azacitidine

    (azacitidine is given as subcutaneous injections once daily for 7 days, every 28 days)

    Main aim : Study will assess the platelet supportive care effects of eltrombopag - by veryfying which group of patients will be platelet transfusion free during the first four cycles of treatment.

    Secondary aim: compare the 2 treatment groups in regards to
    overall survival,
    disease response,
    haematologic improvement,
    platelet and red blood cell transfusions,
    adverse events,
    safety and tolerability,
    health related quality of life and
    medical resource utilization

  2. Main basic inclusion criteria: Platelet transfusion dependent MDS patients
  3. Main basic exclusion criteria: tbc
  4. Trial sites/locations and name of physician in charge of trial:
  5. More information: https://clinicaltrials.gov/ct2/show/NCT01286038

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

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