Acute myeloid leukemia (AML) patients over 60 Cancer Myeloid leukaemia
Conditions
Interventions
The following treatments will be compared
1. Low dose Ara-C (cytarabine): 20 mg twice a day (b.i.d) by subcutaneous injection daily on days 1-10 (20 doses) to be repeated at 28 to 42 d
Sponsors
Cardiff University (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients have one of the forms of acute myeloid leukaemia, except Acute Promyelocytic Leukaemia as defined by the WHO Classification (Appendix A) this can be any type of de novo or secondary AML ? or high risk Myelodysplastic Syndrome, defined as greater than 10% marrow blasts (RAEB-2) 2. Normally over the age of 60, but patients under this age are eligible if they are not considered fit for the NCRI AML16 trial or any subsequent equivalent trial 3. Written informed consent 4. For the AC220 interventions cardiac criteria must be met. Electrolyte levels of potassium, magnesium and calcium must be within the institutional normal range
Exclusion criteria
Exclusion criteria: 1. Patients have previously received cytotoxic chemotherapy for AML. (Hydroxycarbamide or similar low-dose therapy, to control the white count is not an exclusion criterion) 2. For AC220 treatment the following criteria make a patient ineligible for that randomisation: 2.1. A myocardial infarction within 12 months 2.2. Uncontrolled angina within 6 months 2.3. Current or history of congestive heart failure New York Heart Association (NYHA) class 3 or 4, unless an echocardiogram (ECHO) or multiple gated acquisition scan (MUGA) performed either within 1 month prior to study screening or during screening results in a left ventricular ejection fraction (LVEF) that is = 45% (or institutional lower limit of normal value) 2.4. Diagnosed or suspected congenital long QT syndrome. Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, torsades de pointes [TdP]) or any history of arrhythmia will be discussed with the clinical coordinator/safety physician prior to patient?s entry into the study 2.5. Prolonged QTcF interval on pre-entry ECG (=450 ms) 2.6. Any history of second or third degree heart block (may be eligible if the patient currently has a pacemaker 2.7. Heart rate < 50/minute on pre-entry ECG 2.8. Uncontrolled hypertension 2.9. Obligate need for a cardiac pacemaker 2.10. Complete left bundle branch block 2.11. Atrial fibrillation 3. In blast transformation of chronic myeloid leukaemia (CML) 4. Concurrent active malignancy under treatment 5. Pregnant or lactating 6. Acute Promyelocytic Leukaemia 7. Known infection with human immunodeficiency virus (HIV)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Overall survival 2. Complete remission (CR + CRi) achievement and reasons for failure (for induction questions) assessed locally via bone marrow samples (as per standard care) after each course 3. Duration of response (CR, CRi) relapse rates and deaths in first CR 4. Toxicity, both haematological and non-haematological 5. Supportive care requirements (and other aspects of health economics) 6. Quality of Life Assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Presence of a cytogenetic abnormality in the bone marrow of patients in morphological remission 2. Molecular characteristics and response to treatment | — |
Countries
Australia, Denmark, France, United Kingdom, Wales
Outcome results
None listed