MAGIC-AML
Project data
Project financing: 32 205 666,50 zł (including financing for UMED: 19 198 375,50 zł), financed by the Medical Research Agency (ABM) - ABM/2022/1
Project description:
The Project funded by the Medical Research Agency under the competition for non-commercial clinical trials – 2022/ABM/1 introduces a comprehensive, modern and personalised treatment of acute myeloid leukaemia (AML), which is one of the most aggressive haematopoietic malignancies and accounts for approximately 80% of all acute leukaemias in adults.
The Medical University of Lodz is the Project Leader in a consortium with the M. Kopernik Regional Multispecialist Oncology and Traumatology Centre in Lodz and the Association of the Polish Adult Leukaemia Group (PALG).
The multicentre “MAGIC-AML” clinical trial will be conducted in 13 polish voivodeships: Łódzkie, Śląskie, Podkarpackie, Małopolskie, Pomorskie, Dolnośląskie, Lubelskie, Wielkopolskie, Warmińsko-Mazurskie, Mazowieckie, Kujawsko-Pomorskie and Świętokrzyskie. The study is planned to provide care to approximately 150-200 patients per year to reach the target number of 520 patients within the 42-month recruitment period.
The main goal is to combine the standard of care induction treatment (daunorubicin+cladribine, DAC) with targeted therapies in 3 subgroups of patients: those with CBF-AML mutation (DAC+Gemtuzumab Ozogamycin), those with FLT3 mutation (DAC+Midostaurin) and in other mutations (DAC+Venetoclax vs. Placebo) in order to increase the remission rate after the induction treatment (EFS), as well as to increase the overall survival (OS).
In addition, the study has the exploratory objectives to analyse the impact of the additional mutations presence in the treatment outcomes in each arm of the study; and to verify the feasibility of monitoring MRD (Minimal Residual Disease) by NGS (Next Generation Sequencing) and the usefulness of multimodal MRD assessment (FC + RT-PCR + NGS) as well as the kinetics of MRD changes during treatment and its relevance for identifying key points for changes in therapeutic decisions.
The clinical trial “MAGIC-AML” and its’ results will consist a basis for the creation of a modern AML treatment algorithm in Poland and worldwide.
Beneficiary
Consortium composed of:
Medical University of Lodz (Leader)
Regional Multi-specialty Centre of Oncology and Traumatology them. M. Copernicus in Łódź (Partner)
Polish Adult Leukemia Group PALG (Partner)
Coordinating Principal Investigator
prof. Agnieszka Wierzbowska, MD, PhD