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A phase Ib/II clinical evaluation of Ponatinib in combination with 5-azacytidine in patients failing prior therapy for FLT3-ITD positive acute myeloid leukaemia (AML M21)
Australasian Leukaemia and Lymphoma Group (ALLG)
The study is evaluating Ponatinib in combination with 5-azacytidine in patients failing prior therapy for FLT3-ITD positive acute myeloid leukaemia (AML M21).
Who is it for? You may be eligible to join this study if you are aged over 18 years, have enrolled in the Australasian Leukaemia and Lymphoma Acute Myeloid Leukaemia ( ALLG AML) registry, have FLT3-ITD AML (except Acute Promyelocytic Leukaemia) failing prior chemotherapy (excluding hydroxyurea and thioguanine).
This study has two parts: Phase Ib which involves finding the best dose of Azacytidine to combine with Ponatinib in terms of patient tolerability and safety.
In Phase II of the study, patients will be randomly (by chance) assigned to 3 groups; one group will receive Ponatinib alone, the other will receive Azacytidine alone and the last group will receive both drugs.