At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Quizartinib (drug), Placebo (drug), Chemotherapy (drug)
- How long the study runs
- Study runs about 67 months (dates as stated)
- About the drug or intervention
- Quizartinib — drug: Participants will receive quizartinib at 60 mg/day orally once daily · Placebo — drug: Participants will receive placebo at 60 mg/day orally once daily · Chemotherapy — drug: Participants will receive commercially available cytarabine (cytosine arabinoside) and anthracycline (daunorubicin or idarubicin).
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 70 Years
- Who
- All
- Number of participants
- 700
- Started
- 2024-11-19
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for leukemia
- • Phase3 - 700 participants
- • This study will compare the effects of Quizartinib versus placebo in combination with chemotherapy in participants with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML)
Who can take part?
- • Ages 18 Years to 70 Years
- • Diagnosed with leukemia
Where?
- • Birmingham - Queen Elizabeth Hospital
- • Harrow - Northwick Park Hospital
- • London - King'S College Hospital
- • London - Hammersmith Hospital
- • +4 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This study will compare the effects of Quizartinib versus placebo in combination with chemotherapy in participants with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML).
More detail
This is a clinical trial to compare the effect of quizartinib versus placebo (administered with standard induction and consolidation chemotherapy, then administered as maintenance therapy for up to 36 cycles) on the primary endpoint of overall survival (OS) in adult patients with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML). Participants will be tested for FLT3-ITD mutation status in a central laboratory using a validated assay.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 70 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Must be competent and able to comprehend, sign, and date an Ethics Committee (EC)- or Institutional Review Board...
- ✓≥18 years or the minimum legal adult age (whichever is greater) and ≤70 years (at Screening).
- ✓Newly diagnosed, morphologically documented primary AML based on the World Health Organization (WHO) 2016...
- ✓activity scale (ECOG) performance status (at the time the participant signs their ICF) of 0-2.
- ✓Participant is a candidate for standard "7+3" induction drug treatment regimen as specified in the protocol per...
Who cannot take part
- ✗Diagnosis of AML secondary to prior drug treatment or radiotherapy.
- ✗Participants with newly diagnosed AML with FLT3-ITD mutations (FLT3-ITD \[+\]) present at ≥5% VAF (or ≥0.05 SR)...
- ✗Prior treatment for AML, except for the following allowances prior to Day 1 of drug treatment:
- ✗Leukapheresis;
- ✗Treatment for hyperleukocytosis with hydroxyurea;
See the full criteria
Where Is This Study? (8 UK sites)
Queen Elizabeth Hospital
Birmingham, United Kingdom
Northwick Park Hospital
Harrow HA1 3UJ, United Kingdom
King'S College Hospital
London SE5 9NU, United Kingdom
Hammersmith Hospital
London W12 0HS, United Kingdom
Maidstone Hospital
Maidstone ME16 9QQ, United Kingdom
Denise Day / Julie Knowles
mtw-tr.researchgovernance@nhs.net01622 225627Manchester Royal Infirmary
Manchester M13 9WL, United Kingdom
Churchill Hospital
Oxford OX3 7LJ, United Kingdom
Torbay Hospital
Torquay TQ2 7AA, United Kingdom
