1. SUB-TYPE OF MDS: Patients with MDS or CMML who have relapsed from or are refractory to previous therapy
2. SEVERITY OF MDS: Intermediate, High or Very High Risk
3. NAME OF DRUG: KRT-232
4. Aims and benefits: This Phase Ib/2 study that investigates the safety and effectiveness of KRT-232 when taken alone and in combination with Low-dose Cytarabine or Decitabine in patients with acute myeloid leukaemia (AML) including AML secondary to myeloproliferative disorders.
5. Primary outcome: To determine the recommended dose of KRT-232 as well as its safety and tolerability. KRT-232 targets MDM2 thus preventing it from inhibiting p53. P53 has a role in arresting the tumour cell cycle and in promoting programmed death of tumour cells.
6. Secondary outcome: To determine response rates.

1. Basic inclusion criteria:
   • Patients with relapsed/refractory AML or AML secondary to myeloproliferative neoplasm.
2. Basic exclusion criteria:
   • Patients who are TP53 mutation positive.
   • Prior treatment with an MDM2 antagonist therapy.
   • Stem cell transplant within 3 months or active graft versus host disease.
   • CNS involvement with AML.
3. Trial sites/locations and name of physician in charge of trial (none are currently recruiting):
   • University Hospital of Wales, Cardiff
   • The Royal Marsden Hospital, London

If you think this information is relevant to you, please discuss it with your own physician.