Phase II trial compares quizartinib vs placebo with chemotherapy in FLT3 wild-type AML
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Key Takeaway
Review the trial design comparing quizartinib to placebo with chemotherapy in FLT3 wild-type AML.
This multicenter, prospective, randomized, placebo-controlled, double-blinded phase II trial compared 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. The trial enrolled 273 patients and was conducted in two phases. First, an open-label safety run-in phase involved 9 patients receiving cytarabine 200 mg/m² (days 1-7), idarubicin 12 mg/m² (days 1-3), and quizartinib 60 mg/day for 14 days (or 30 mg with a strong CYP3A inhibitor) during one induction cycle to establish the final dose for the randomized phase. Second, a randomized double-blinded phase assigned patients in a 2:1 ratio to receive quizartinib at the established dose versus placebo, both combined with the chemotherapy backbone. The primary outcome measure was event-free survival rate. The study started on September 5, 2019, and reached primary completion on October 3, 2024. The abstract does not report specific efficacy results, safety data, or statistical comparisons between the treatment arms.
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View Original Abstract ↓
Status: COMPLETED | Phase: PHASE2
Condition(s): Acute Myeloid Leukemia
Intervention(s): Quizartinib (DRUG), Placebo oral tablet (DRUG), Cytarabine (DRUG), Idarubicin (DRUG)
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
Detailed: Multicenter, prospective, randomized, placebo-controlled, double-blinded phase II trial to assess the efficacy and safety of an oral quizartinib vs. placebo containing front-line chemotherapy-based schedule in FMS-like tyrosine kinase 3 internal tandem duplications (FLT3-ITD) wild-type Acute Myeloid Leukemia patients.
The trial will be conducted in two phases:
An open-label safety run-in phase: Cytarabine 200 mg/m2 (days 1-7), Idarubicin 12 mg/m2 (days 1-3) Quizartinib 60 mg/d x 14 days (30mg with strong Cytochrome P450 Family 3 Subfamily A (CYP3A) inhibitor) in a total of 9 patients, being observed during 1 cycle of induction to define the final dose for the randomized phase.
A randomized double-blinded phase 2:1 quizartinib (at the established dose) vs. placebo.
Experimental Arm: Cyt
Primary Outcome(s): Event-free survival rate
Enrollment: 273 (ACTUAL)
Lead Sponsor: PETHEMA Foundation
Start: 2019-09-05 | Primary Completion: 2024-10-03
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