Patients who have Acute Myeloid Leukaemia (AML) will be recruited to this trial. MedDRA version: 9.1 Level: LLT Classification code 10000880 Term: Acute myeloid leukaemia
Conditions
Interventions
Trade Name: Vidaza
Product Name: Azacitidine
Pharmaceutical Form: Powder for solution for injection
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients >18 years and in whom allogeneic transplantation using a myeloablative conditioning regimen is contra-indicated. 1) Diagnosis • Patients who fulfil WHO criteria for AML 2) Patients with a HLA identical sibling or suitable matched unrelated donor. Suitable match equals no greater than a single allele mismatch and considered fit for reduced intensity transplant. 3) Give written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice. 4) Be willing and able to comply with the protocol for the duration of the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1) Patients with contraindications to receiving transplant conditioning therapy 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 study. 3) Any co-morbidity that in the investigators opinion will affect the patients participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: -To evaluate the effect of Azacitidine on the kinetics of disease relapse. -To document the impact of adjunctive Azacitidine on GVHD and chimerism (lineage specific where possible). ;Primary end point(s): Document the tolerability of Azacitidine post transplant ;Main Objective: To assess the safety and tolerability of Azacitidine in patients following reduced intensity conditioned allogeneic transplantation for AML. | — |
Countries
United Kingdom
Outcome results
None listed