Dr. Carolyn Grove

Australasian Leukaemia & Lymphoma

2

Acute Myeloid Leukaemia

This trial is for patients ≥ 60 years of age with newly diagnosed acute myeloid leukaemia who are unfit for intensive chemotherapy. Patients will be assigned to a treatment group based on their AML cytogenetics. All patients will receive low dose cytaribine (LDAC) chemotherapy and venetoclax.  This will be given in combination with either pracinostat, a HDAC inhibitor which stops cancer cells from dividing, or midostaurin which is a FLT3 inhibitor that inhibits leukemic cell production.

Key Inclusion Criteria

1. Must be enrolled onto the NBCR
2. Age ≥ 60
3. Unfit for intensive chemotherapy in the opinion of the investigator
4. No prior treatment for AML (except hydroxyurea or thioguanine)
5. ECOG 0 2
6. Adequate liver function (AST or ALT < 1.5x ULN and bilirubin ≤1.5x ULN*). *unless considered related to AML or Gilbert’s syndrome
7. Adequate renal function as demonstrated by a Cockcroft Gault formula creatinine clearance of ≥ 30mL/min

Key Exclusion Criteria

1. WBC >25 x10^9/L. Hydroxyurea may be used to control the WBC count
2. APL or core binding factor AML
3. Antecedent myelofibrosis (including primary and secondary)
4. Active CNS leukaemia
5. Prior exposure to venetoclax, FLT3 inhibitors or pracinostat
6. Viral infection with known HIV or viral hepatitis type B or C not adequately controlled by antiviral medication
7. History of other malignancy requiring active systemic treatment or which is likely to result in an expected survival time of <2 years
8. QT interval corrected according to Fridericia’s formula ( QTcF ) >450ms
9. Clinically significant uncontrolled conditions
10. Treatment with steroid therapy for anti neoplastic intent, moderate or strong CYP3A inhibitors, moderate or strong CYP3A inducers within 7 days prior of dose
11. (For pracinostat arm) Must have stopped smoking within 8 days prior of first dose of study drug
12. Consumption of grapefruit, Seville oranges, starfruit within 3 days prior to first dose of study drug

Louise Hay

louise.hay@health.wa.gov.au

08 6383 3207

AMLM25

ACTRN12619001655134P