1. SUB-TYPE OF MDS:Previously untreated higher-risk MDS, AML or CMML
  2. SEVERITY OF MDS: Intermediate, high risk or very high risk MDS as defined by the World Health Organization (WHO) criteria or Revised International Prognostic Scoring System (IPSS-R)
  3. NAME OF DRUG: Glasdegib, Azacitidine
  4. Aims and benefits: PGlasdegib disrupts cancer stem cell survival. This has the potential to reduce the development of drug resistance and prevent relapse. This is a Phase 1b study aimed at determining the safety and effectiveness of Glasdegib in combination with Azacitidine in this specific patient group.

  1. Primary outcome measures: 
    Assessing complete remission rates and adverse events.
  2. Secondary outcome measures:
    To determine response rates and the rates of haematologic improvement.
  3. Basic inclusion criteria:
    • Clinical indication for treatment with Azacitidine.
    • Previously untreated higher-risk (Intermediate, high risk or very high risk) MDS, AML or CMML.
  4. Basic exclusion criteria:
    • Patients with AML who are suitable for standard induction chemotherapy as first line treatment.
    • Known active CNS leukaemia.
    • Prior treatment with a smoothened inhibitor and/or a hypomethylating agent.
  5. Trial sites/locations and name of physician in charge of trial:
    • Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool
    • King’s College Hospital NHS Foundation Trust, London
    • Newcastle Hospitals NHS Foundation Trust, Newcastle upon Tyne
    • Oxford University Hospitals NHS Foundation Trust, Oxford

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

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