AMLM25
An ALLG Phase 2 study to Investigate Novel Triplets to Extend Remission with Venetoclax in Elderly Acute Myeloid Leukaemia.
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
- Must be enrolled onto the NBCR
- Age ≥ 60
- Unfit for intensive chemotherapy in the opinion of the investigator
- No prior treatment for AML (except hydroxyurea or thioguanine)
- ECOG 0 2
- Adequate liver function (AST or ALT < 1.5x ULN and bilirubin ≤1.5x ULN*). *unless considered related to AML or Gilbert’s syndrome
- Adequate renal function as demonstrated by a Cockcroft Gault formula creatinine clearance of ≥ 30mL/min
Key Exclusion Criteria
- WBC >25 x10^9/L. Hydroxyurea may be used to control the WBC count
- APL or core binding factor AML
- Antecedent myelofibrosis (including primary and secondary)
- Active CNS leukaemia
- Prior exposure to venetoclax, FLT3 inhibitors or pracinostat
- Viral infection with known HIV or viral hepatitis type B or C not adequately controlled by antiviral medication
- History of other malignancy requiring active systemic treatment or which is likely to result in an expected survival time of <2 years
- QT interval corrected according to Fridericia’s formula ( QTcF ) >450ms
- Clinically significant uncontrolled conditions
- Treatment with steroid therapy for anti neoplastic intent, moderate or strong CYP3A inhibitors, moderate or strong CYP3A inducers within 7 days prior of dose
- (For pracinostat arm) Must have stopped smoking within 8 days prior of first dose of study drug
- Consumption of grapefruit, Seville oranges, starfruit within 3 days prior to first dose of study drug
AMLM25
ACTRN12619001655134P