Acute myeloid leukaemia (AML) or myelodysplasia (MDS) Cancer Acute myeloid leukaemia (AML) or myelodysplasia (MDS)
Conditions
Interventions
All participants will receive azacitidine administered six weeks after undergoing reduced intensity conditioned allogeneic transplantation. Azacitidine will be administered subcutaneously for 5 days f
follow up period: 24 months.
Sponsors
University of Birmingham (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients (male and female) between the age of 18 - 65 years in whom allogeneic transplantation using a myeloablative conditioning regimen is contra-indicated 2. Patients who fulfill the World Health Organization (WHO) criteria for AML or MDS 3. Patients with a human leukocyte antigen (HLA) identical sibling or suitable matched unrelated donor 4. Must give written informed consent and be able to comply with the protocol for the duration of the study
Exclusion criteria
Exclusion criteria: 1. Patients with contra-indications to receiving fludarabine or azacitidine 2. Pregnant or lactating women or adults of reproductive potential not willing to use appropriate medically approved contraception during the trial and for 12 months post-azacitidine 3. Any co-morbidity that in the investigators opinion will affect the patients participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of azacitidine treatment. Adverse events and therapy-related side effects will be monitored continuously during azacitidine treatment and until 28 days after the last dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Relapse rate, assessed at 12 months post-transplant 2. Survival, assessed annually until 3 years post-transplant | — |
Countries
England, United Kingdom
Outcome results
None listed