ACT-AML-902
Research type
Research Study
Full title
A Phase II, Randomized, Open-Label trial comparing Quizartinib/VEN/AZA (intervention) versus DA/Quizartinib (control) in Older Fit Adults with Newly Diagnosed FLT3-ITD mutated Acute Myeloid Leukaemia (QUIZZICAL)
IRAS ID
1012898
Contact name
Paul Robinson
Contact email
Sponsor organisation
DIDACT Foundation
Research summary
This study is for adults who have been recently diagnosed with a type of blood cancer called acute myeloid leukaemia (AML) with a specific genetic change known as FLT3-ITD. In this study, intensive chemotherapy treatment, which is normally used to treat patients with AML, is known as “Standard of Care” treatment. This study has been designed to compare this standard intensive chemotherapy, with a new combination of three chemotherapy drugs that are less intensive but have the potential to be equally or more effective. The hope is that this new combination may offer patients a better chance of reaching the stem cell transplant stage with fewer side effects.
Previous studies have shown that treatments including quizartinib can be effective and generally well tolerated in people with newly diagnosed FLT3-ITD positive acute myeloid leukaemia. This study is being performed to compare two commonly used treatment approaches to see which leads to longer event-free survival (the length of time before the disease comes back, worsens, or a new treatment is needed).
Participants will be randomised into one of two treatment groups:
• The standard of care group ARM A, will receive standard intensive chemotherapy (Daunorubicin and Cytarabine) together with a medicine called quizartinib. This treatment is usually in one or two cycles.
• Experimental treatment group ARM B, will receive a combination of three medicines VENETOCLAX/AZACITIDINE/QUIZARTINIB. These medicines are already used to treat this condition, but they are being studied together to see how effective they are when combined.
Recruitment of the 140 participants is anticipated to take about 24 months. Each participant will be followed for at least 12 months from the date of the last participants to enter the study. Total study duration could be up to 36 months for some participants. Patients will be recruited from UK and US sites.REC name
London - Chelsea Research Ethics Committee
REC reference
26/LO/0292
Date of REC Opinion
14 Jul 2026
REC opinion
Further Information Favourable Opinion