Adjunctive use of azacitidine in patients with acute myeloid leukaemia (AML) or myelodysplasia (MDS) undergoing a reduced intensity conditioned allogeneic transplant
- Conditions
- Acute myeloid leukaemia (AML) or myelodysplasia (MDS)Cancer
- Registration Number
- ISRCTN36825171
- Lead Sponsor
- niversity of Birmingham (UK)
- Brief Summary
2012 Results article in http://www.ncbi.nlm.nih.gov/pubmed/22234690 results
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 37
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method <br> 1. Relapse rate, assessed at 12 months post-transplant<br> 2. Survival, assessed annually until 3 years post-transplant<br>