- Investigational drugs: Subcutaneous Azacitidine and Durvalumab, which activates the immune system to have a response against tumor cells.
- For what level of MDS severity risk: High risk; also elderly patients (age ≥ 65 years) with Acute Myeloid Leukaemia
- What subtype of MDS: Intermediate –2 or High Risk
- Aims and benefits: This is a phase 2 study for previously untreated patients with higher risk MDS or elderly patients with AML who are not eligible for haemopoietic stem cell transplant.
Durvalumab is an antibody which works against a specific cell death (PD-L1) which activates the immune system to have a response against tumor cells expressing PD-L1.
(Monoclonal antibody directed against programmed cell death-1 ligand 1 (PD-L1) which activates the immune system to exert a response against tumor cells expressing PD-L1.
The study aims to evaluate the Efficacy and Safety of Azacitidine (subcutaneous) in Combination With Durvalumab
- Primary outcome measures:
- Overall response rate
- Secondary outcome measures:
- Time to response, cytogenetic response, progression-free survival, duration of haematological response, time to AML transformation (for MDS patients)
- Basic inclusion criteria:
- ECOG performance status of 0, 1 or 2
- Central confirmation of the diagnosis of untreated MDS and of the MDS risk classification as per IPSS-R (Intermediate, High or very High risk) OR
- Central confirmation of the diagnosis of untreated AML with intermediate or poor risk status based on cytogenetics.
- Basic exclusion criteria:
- Prior haematopoietic stem cell transplant
- Patient considered eligible for haematopoietic stem cell transplant
- Prior exposure to Azacitidine, decitabine or exposure to the investigational oral formulation of Decitabine or other oral Azacitidine derivative
- Significant liver or kidney impairment
- Patients with active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease, diverticulitis with the exception of a prior episode that has resolved or diverticulosis, celiac disease, irritable bowel disease active within the last 6 months or other serious gastrointestinal chronic conditions associated with diarrhoea; systemic lupus erythematosus; Wegener's syndrome [granulomatosis with polyangiitis]; myasthenia gravis; Graves' disease; rheumatoid arthritis; hypophysitis, uveitis; etc) within the past 3 years prior to the start of treatment.
- Trial sites/locations and name of physician in charge of trial:
University Hospital Birmingham, Birmingham; St James University Hospital, Leeds; University College Hospital, London; St Bartholomews Hospital, London; Kings College Hospital, London; The Christie NHS Foundation Trust, Manchester; John Radcliffe Hospital, Oxford; The Royal Marsden NHS Foundation Trust, Sutton
- More information:
Please read information and always discuss trial information with your own physician.