AMLM22/D2
The International Acute myeloid leukaemia (AML) Platform Consortium (IAPC) trial is a randomised, multi-arm study platform to compare the efficacy of experimental therapies versus standard of care in subjects with acute myeloid leukaemia in first complete remission. Domain 2 is investigating the safety and efficacy of Venetoclax as a maintenance therapy alone or in combination with low dose cytarabine (LDAC).
Dr. Carolyn Grove
Australasian Leukaemia and Lymphoma Group (ALLG)
2
Acute Myeloid Leukemia (AML)
This trial is suitable for acute myeloid leukaemia patients who have achieved first complete remission after intensive chemotherapy. Various treatment domains will be added to this trial with time but at present patients will be randomised to Venetoclax alone or in combination with a chemotherapy called Low Dose Cytarabine (LDAC); or standard of care which is generally observation. Venetoclax will be taken by mouth daily and LDAC is administered under the skin for a total of 24 months.
Inclusion Criteria
- ECOG 0-2
- AML (excluding APL) in first complete remission with bone marrow blasts <5%
- Age 18+
- Adequate renal function demonstrated by creatinine clearance greater than or equal to 30mL/min
- Adequate liver function
Exclusion Criteria
- Chemotherapy or investigational agents within 28 days of planned Cycle 1 Day 1
- Impaired hematologic recovery 8 weeks after last chemotherapy
- History of malignancy requiring active systemic treatment
- Prior bone marrow or stem cell transplantation
- Viral infection with known HIV or viral hepatitis type B or C not adequately controlled by antiviral medication
- Intent to undertake stem cell transplant procedure within next three months
- Consumption of grapefruit, seville oranges or star fruit within three days prior to first dose of study drug
- Treatment with steroid therapy for anti-neoplastic intent or moderate to strong CYP3A inhibitors
AMLM22/D2
ACTRN12619000280101