Trial to Compare Efficacy and Safety of Chemotherapy/Quizartinib vs Chemotherapy/Placebo in Adult… (NCT04107727) | Clinical Trial Compass
CompletedPhase 2
Trial to Compare Efficacy and Safety of Chemotherapy/Quizartinib vs Chemotherapy/Placebo in Adults FMS-like Tyrosine Kinase 3 (FLT3) Wild-type Acute Myeloid Leukemia (AML)
Spain273 participantsStarted 2019-09-05
Plain-language summary
Randomized phase II trial to compare the efficacy and safety of standard chemotherapy plus quizartinib versus standard chemotherapy plus placebo in adult patients with newly diagnosed FLT3 wild-type Acute Myeloid Leukemia
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Written informed consent in accordance with national, local, and institutional guidelines. The patient must provide informed consent before the first screening procedure. The patient and the investigator must sign informed consent form.
✓. Diagnosis of untreated AML (according to the World Health Organization (WHO) 2008/2016 definition)
✓. Age ≥ 18 and ≤70 years old at the time of screening
✓. Non-FLT3-ITD (allelic ratio \<0.03) at diagnosis
✓. Considered eligible to receive intensive chemotherapy as per investigator judgment
✓. Eastern Cooperative Oncology Group (ECOG) 0-2
✓. No contraindications for quizartinib
✓. The subject is receiving standard "7+3" induction chemotherapy regimen as specified in the protocol
Exclusion criteria
✕. Patients with a genetic diagnosis of acute promyelocytic leukemia
✕. Age \<18 years or \>70 years
✕. ECOG performance status of 3 or 4
✕. Prior treatment for AML, except for the following allowances:
✕. Blastic phase of bcr/abl chronic myeloid leukemia.
What they're measuring
1
Event-free survival rate
Timeframe: Through study completion, an average of 5 years