FLT3-TKD mutation

P=N/A, N=20, Recruiting, The First Affiliated Hospital of Soochow University

Studies have shown that the FLT3-ITD mutation is the most prevalent mutation among Iranian AML patients. Following this, the most common mutations identified were NPM1, CEBPA, DNMT3A, and WT1, in that order.

Absence of pathogenic variants in the cord blood supports de novo leukemogenesis. These findings implicate host or microenvironmental factors in driving leukemic transformation and highlight potential shared selective pressures in FLT3-TKD mutant AML.

P3, N=300, Not yet recruiting, Institute of Hematology & Blood Diseases Hospital, China | Initiation date: Jan 2026 --> Apr 2026

All fit patients with FLT3m-AML must receive intensive chemotherapy plus a FLT3i (midostaurin or quizartinib) and be evaluated for allo-HSCT. For unfit patients, the current standard of HMA + venetoclax is considered suboptimal, making the search for alternative strategies imperative...In the R/R setting, retesting the FLT3 status is mandatory, and gilteritinib is the standard treatment, serving as a bridge-to-transplant and for post-HSCT maintenance. The integration of FLT3i has shifted FLT3m-AML into a more favorable intermediate prognostic category, enhancing the role of curative strategies like allo-HSCT. This consensus paper provides a structured evidence-based comprehensive guide, translating complex data into clear actionable clinical recommendations that minimize practice variability and ultimately optimize management for this high-risk population.

P3, N=300, Not yet recruiting, Institute of Hematology & Blood Diseases Hospital, China

P2, N=19, Active, not recruiting, Centre Antoine Lacassagne | Recruiting --> Active, not recruiting | N=50 --> 19 | Trial completion date: Mar 2027 --> Jul 2028 | Trial primary completion date: Mar 2027 --> Jul 2028

P2, N=153, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2027

The complexity of AML was influenced by various cytogenetic and molecular abnormalities, which contributed to patients' heterogeneous presentation and survival outcomes. In addition to the previous data, IDH1, IDH2, and DNMT3A mutations might have affected survival outcomes in AML patients in our retrospective cohort. However, further studies with larger sample sizes are needed to validate these observations.

Triplet combinations of an HMA, venetoclax and a FLT3 inhibitor result in durable remission and encouraging long-term OS in older adults with newly diagnosed FLT3-mutated AML. However, better strategies to prevent FLT3 wild type relapses and to overcome RAS pathway-mediated resistance are still needed.

P1, N=22, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial primary completion date: Jan 2025 --> Feb 2027 | Trial completion date: May 2026 --> Mar 2027

We described the distribution of FLT3 mutations; further work is needed to understand prevalence estimate heterogeneity.