ACT-AML-101
Research type
Research Study
Full title
A Phase II, Randomised, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination with Venetoclax and Azacitidine versus Intensive Chemotherapy in Fit Adults with High Risk Newly Diagnosed Acute Myeloid Leukaemia
IRAS ID
1006624
Contact name
Cecilia Adetola
Contact email
Sponsor organisation
DIDACT Foundation
Research summary
This study is for people with a type of cancer of the bone marrow called Acute Myeloid Leukaemia (AML). The purpose of this study is to test the safety and effectiveness of a new combination of three medicines (magrolimab, venetoclax and azacitidine; Arm B) compared with the normal standard of care intensive chemotherapy treatment (Arm A), in fit adults with newly diagnosed AML. The aim is to increase the number of patients who can proceed to a potentially curative stem cell transplant.
Magrolimab is a new medicine which is currently under investigation in other studies for patients with AML but has not yet been tested in patients who need intensive treatment. Venetoclax and azacitidine are already given together to patients with AML who cannot have intensive chemotherapy.
Patients will be assigned randomly to one of two groups (Arms A and B). Patients in both Arms will receive a minimum of two cycles of induction treatment.
Standard of care induction chemotherapy will be either daunorubicin and cytarabine (DA), DA and gemtuzumab ozogamicin (DA+GO), a combination of daunorubicin and cytarabine called CPX-351 (Vyxeos), or fludarabine, cytarabine, granulocyte-colony stimulating factor (G-CSF) and idarubicin (FLAG-Ida).
There will be about 164 people taking part in this study within 18 UK hospital research sites. Patients will be male and female, aged 18 to 70 years. Patients will be recruited over approximately 18 months and followed up for up to 5 years. This study will consist of Screening, Study Treatment, Study Treatment Discontinuation, Long-Term Follow-Up and Survival Follow Up periods.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
23/NE/0047
Date of REC Opinion
11 Sep 2023
REC opinion
Further Information Favourable Opinion