A phase Ib/II clinical evaluation of Ponatinib in combination with 5-azacitidine in FLT3-ITD positive acute myeloid leukaemia (AMLM21)
| DOI number | 10.58109/e78k-5034 |
| Publisher | Australasian Leukaemia and Lymphoma Group (ALLG) |
| Creator(s) | Australasian Leukaemia and Lymphoma Group (ALLG) Andrew Wei (The Alfred Hospital) |
| Date Made Available | 2026 |
| Dataset | Individual participant data (IPD) in aggregate form |
| Description of Dataset | This dataset includes data for ALLG AMLM21 trial participants (19 male, 14 female, ages 24-87) with FLT3-ITD or CBL mutant AML (except Acute Promyelocytic Leukaemia) failing prior chemotherapy (i.e. relapsed or refractory) or who are considered unfit for frontline intensive chemotherapy, taking part in the PHASE Ib/II AMLM21 study. Data for the single treatment ARM is available (Ponatinib plus azacitidine). Participants were recruited at sites Australia wide, and includes data from treatment until disease progression, and up to a 5 year period in follow up. The study commenced in 2016 and conducted the last patient last visit in 2025. Dataset includes Timepoints at screening, end of each cycle up to cycle 24 and at relapse, Correlative samples (Collected), QOL (Collected, via EQ-5D and QLQ-C30). |
| Funding | Australasian Leukaemia and Lymphoma Group (ALLG) |
| Subject (ANZSRC Category) | Cancer therapy (excl. chemotherapy and radiation therapy) |
| ANZCTR Reference | ACTRN12614000810617 |
| Publication(s) | |
| Dataset Access | Access can be requested via the Health Data Australia catalogue. Search for the ACTRN number in the catalogue to find datasets associated with this trial or email enquiries to info@allg.org.au |
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