- SUB-TYPE OF MDS:Previously untreated higher-risk MDS, AML or CMML
- 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)
- NAME OF DRUG: Glasdegib, Azacitidine
- 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.
- Primary outcome measures:
Assessing complete remission rates and adverse events.
- Secondary outcome measures:
To determine response rates and the rates of haematologic improvement.
- Basic inclusion criteria:
- Clinical indication for treatment with Azacitidine.
- Previously untreated higher-risk (Intermediate, high risk or very high risk) MDS, AML or CMML.
- 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.
- 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.