QuANTUM-Wild: A phase 3, randomized, double-blind, placebo-controlled trial of quizartinib in combination with chemotherapy and as single-agent maintenance in FLT3 -ITD–negative acute myeloid leukemia (AML)
Abstract
TPS6580
Background:
Quizartinib (Quiz) is an oral, selective, type-II FLT3 inhibitor with potent activity against wild-type (wt) FLT3, FLT3-ITDs, and other kinase domain variants. Quiz is approved for patients (pts) with
FLT3
-ITD+ newly diagnosed (ND) AML based on results from the QuANTUM-First trial (NCT02668653). Mutations in the
FLT3
gene are observed in ~30% of AML cases, most commonly as ITDs, but
they are not the only mechanism affecting FLT3 activation. Elevated expression of the FLT3 receptor is observed in nearly all cases of AML, and high levels of
FLT3
gene expression are detected in 70–100% of AML blasts, independent of the presence of
FLT3
gene mutations, potentially contributing to leukemic cell survival and proliferation. Evidence from preclinical and clinical studies supports Quiz activity in
FLT3
-ITD–negative (
FLT3
-ITDneg) AML. In the phase 2 QUIWI trial, the addition of Quiz to standard chemotherapy and as single-agent maintenance significantly prolonged overall survival (OS) vs placebo (Pbo) in ND
FLT3
-ITDneg AML. QuANTUM-Wild is a global, phase 3, double-blind, Pbo-controlled trial evaluating Quiz with standard induction/consolidation chemotherapy and as maintenance in ND
FLT3
-ITDneg AML (NCT06578247).
Methods:
Eligible pts are aged 18–70 years with
FLT3
-ITD allelic frequency < 5%. Treatment includes standard induction with cytarabine and an anthracycline plus Quiz/Pbo, followed by up to 4 cycles of consolidation (+/– allo-HSCT) with high-dose…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
Read the paper
Related studies
- Chaos and quantum thermalization
- The Dalton quantum chemistry program system
- Quantum dots: synthesis, bioapplications, and toxicity
- Cord Blood Leptin and Adiponectin as Predictors of Adiposity in Children at 3 Years of Age: A Prospective Cohort Study
- A Guide to In Silico Drug Design
- Quantitative metabolomics by H-NMR and LC-MS/MS confirms altered metabolic pathways in diabetes
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.