Trial reportBlood advances2026
Long-term outcomes of azacitidine, venetoclax, and gilteritinib in newly diagnosed FLT3-mutated AML.
Trial report in Blood advances, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04140487 (A Phase I/II Study of Azacitidine, Venetoclax, and Gilteritinib for Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome With an Activating FLT3 Mutation), which is not on this map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase I/II Study of Azacitidine, Venetoclax, and Gilteritinib for Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome With an Activating FLT3 Mutation
Who cites it
2 citing papers in PubMed.
- Current and future therapies for acute myeloblastic leukemia.Journal of hematology & oncology · 2026Review
- Stretching a doublet into a triplet for FLT3 AML.Blood advances · 2026Article
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Authors and funding
22 authors.
Funding
Abstract
abstractAmong patients with FLT3-mutated acute myeloid leukemia (AML) who receive frontline azacitidine plus venetoclax, relapses are commonly driven by the expansion of the FLT3-mutated clone, supporting FLT3 inhibitor-based triplet lower-intensity regimens. We report long-term outcomes of a phase 2 study of azacitidine, venetoclax, and gilteritinib for adults with newly diagnosed FLT3-mutated AML who were unfit for intensive chemotherapy. Thirty patients were treated; median age was 71 years, and 22 (73%) had an FLT3 internal tandem duplication (FLT3-ITD) mutation. The complete remission (CR)/CR with incomplete hematologic recovery rate was 96%, and 14 patients (47%) underwent allogeneic hematopoietic stem cell transplantation (HSCT) in first remission. With a median follow-up of 41.5 months, 11 patients (37%) relapsed; in 67% of evaluable relapses, the FLT3 mutation was not detectable. The median relapse-free survival (RFS) and overall survival (OS) were 23.4 and 29.7 months, respectively, and the 3-year RFS and OS rates were 43% and 46%, respectively. Among patients with FLT3-ITD-mutated AML, the median RFS and OS were 17.0 and 21.8 months, respectively, and the 3-year RFS and OS rates were 32% and 36%, respectively. The presence of a baseline RAS pathway mutation was associated with worse outcomes. Survival rates were similar regardless of HSCT in first remission. Among patients who received ≥1 consolidation cycle, 68% had a reduction in the dose or duration of at least one of the study drugs. The triplet regimen of azacitidine, venetoclax, and gilteritinib is associated with durable remissions and encouraging long-term survival. Randomized studies comparing this regimen to standard of care approaches are warranted. This trial was registered at www.clinicaltrials.gov as #NCT04140487.
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