None listed
Conditions
Brief summary
To examine the safety and tolerability of Everolimus in combination with 5-azacitidine in Acute Myeloid Leukaemia.
Interventions
Azacitidine injection given sub-cutaneously for 7 doses D1-5 and D8-9 of a 28 day cycle, dosages at 75mg/m2. Everolimus given orally d5-21, cohorts increasing 2.5mg, 5mg, 10mg. 28 day cycles continue unless disease progression, unacceptable toxicity, or stem cell transplant.
Sponsors
Alfred Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
*Untreated AML patients (defined by WHO 2008 criteria) over the age of 60 or relapsed/refractory AML over the age of 18 who have received up to 2 previous lines of intensive chemotherapy * No prior failure to achieve at least a PR with Azacitidine or Everolimus * Provision of written informed consent * Secondary AML (including therapy-related) are included * Life expectancy of greater than 3 months in relation to diseases other then AML/MDS * ECOG performance status 0 – 3 * Electrolyte levels (potassium, calcium (albumin-adjusted), magnesium, phosphorous) within normal limits (WNL) or easily correctable with supplements * Adequate hepatic function as defined by bilirubin = 1.5 x the upper limit of normal (ULN) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 x ULN * Adequate renal function, with serum creatinine = 1.5 x ULN or GFR > 30 ml/minute * Patients with no uncontrolled active infection * Hydroxyurea ceased 48 hours prior to study therapy
Exclusion criteria
* Any serious medical or psychiatric conditions which the investigator feels may interfere with the patient’s ability to give informed consent or participate in the procedures or evaluations of the study * History of major non-compliance to medication * Evidence of CNS leukemia * Uncontrolled viral infection with known HIV or Hepatitis type B or C * Currently active gastrointestinal disease (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, or small bowel resection), or other disease, that prevents the patient from absorbing or taking oral medication * Any other concurrent severe and/or uncontrolled medical conditions (eg. acute or chronic liver disease, infection, pulmonary disease) that in the opinion of the investigator could potentiate unacceptable safety risks or jeopardize compliance with the protocol * Males with a female partner of childbearing potential do not agree to use at least 2 effective contraceptive methods throughout the study and for 6 months following the date of last dose
Outcome results
None listed