Trial reportBlood2022
Phase 3 trial of gilteritinib plus azacitidine vs azacitidine for newly diagnosed FLT3mut+ AML ineligible for intensive chemotherapy.
Trial report in Blood, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02752035 (A Phase 3 Multicenter, Open-label, Randomized Study of ASP2215), which is not on this map. Cited by 84 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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 3 Multicenter, Open-label, Randomized Study of ASP2215 (Gilteritinib), Combination of ASP2215 Plus Azacitidine and Azacitidine Alone in the Treatment of Newly Diagnosed Acute Myeloid Leukemia With FLT3 Mutation in Patients Not Eligible for Intensive Induction Chemotherapy
Who cites it
84 citing papers in PubMed, 5 syntheses or guidelines pooled it, 121 citations in OpenAlex.
- Antileukemic therapies for older adults with AML ineligible for conventional therapy: systematic review and meta-analysis.Blood advances · 2026Pooled it
- American Society of Hematology 2025 guidelines for treating newly diagnosed acute myeloid leukemia in older adults.Blood advances · 2026Guideline
- Safety profile of FLT3 inhibitors in acute myeloid leukemia: a systematic review and meta-analysis of adverse events.Clinical and experimental medicine · 2026Pooled it
- Efficacy and safety of FLT3 inhibitors for acute myeloid leukemia: a network meta-analysis.Frontiers in oncology · 2026Pooled it
- Comparative efficacy and safety in low-intensity treatment for acute myeloid leukemia in older patients: a systematic review and network meta-analysis.European journal of medical research · 2025Pooled it
- Long-term outcomes of azacitidine, venetoclax, and gilteritinib in newly diagnosed FLT3-mutated AML.Blood advances · 2026Trial
- Trial
- Quizartinib and omacetaxine mepesuccinate combination therapy in FLT3-ITD AML: a phase II trial.Nature communications · 2026Trial
- Trial
- Midostaurin added to 10-day decitabine, for patients unfit for intensive chemotherapy with AML and higher risk MDS, irrespective of FLT3 mutational status, does not improve outcome.Annals of hematology · 2025Trial
- Trial
- Azacitidine, Venetoclax, and Gilteritinib in Newly Diagnosed and Relapsed or RefractoryJournal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024Trial
- Pegylated Liposomal Doxorubicin Combined with Cytarabine and Granulocyte Colony-Stimulating Factor for Treating Newly Diagnosed Older and Unfit Acute Myeloid Leukemia Patients: A Prospective, Single-Center, Single-arm, Phase II Study.Technology in cancer research & treatmentTrial
- HMA + venetoclax triplet regimens for the initial treatment of AML in adults.Blood advances · 2026Article
- Current and future therapies for acute myeloblastic leukemia.Journal of hematology & oncology · 2026Review
- Frailty and Fitness in Older Adults With Acute Myeloid Leukemia: From Chronological Age to Multiparametric Assessment.European journal of haematology · 2026Review
- FLT3-mutated AML: standards of care and ongoing investigation.Blood research · 2026Review
- Caring for Older Adults with Acute Myeloid Leukemia: Best Practices for Aligning Patient Fitness and Preference with Available Therapies.Drugs & aging · 2026Review
- Real-World Outcomes of Acute Myeloid Leukemia Patients Undergoing Treatment With Tyrosine Kinase Inhibitor (TKI) Therapy Targeting FLT3, IDH1, or IDH2.Cancer reports (Hoboken, N.J.) · 2026Article
- Novel treatment strategies in acute myeloid leukemia.Blood research · 2026Review
24 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
21 authors at 15 institutions in 12 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Treatment results for patients with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-mutated (FLT3mut+) acute myeloid leukemia (AML) ineligible for intensive chemotherapy are disappointing. This multicenter, open-label, phase 3 trial randomized (2:1) untreated adults with FLT3mut+ AML ineligible for intensive induction chemotherapy to receive gilteritinib (120 mg/d orally) and azacitidine (GIL + AZA) or azacitidine (AZA) alone. The primary end point was overall survival (OS). At the interim analysis (August 26, 2020), a total of 123 patients were randomized to treatment (GIL + AZA, n = 74; AZA, n = 49). Subsequent AML therapy, including FLT3 inhibitors, was received by 20.3% (GIL + AZA) and 44.9% (AZA) of patients. Median OS was 9.82 (GIL + AZA) and 8.87 (AZA) months (hazard ratio, 0.916; 95% CI, 0.529-1.585; P = .753). The study was closed based on the protocol-specified boundary for futility. Median event-free survival was 0.03 month in both arms. Event-free survival defined by using composite complete remission (CRc) was 4.53 months for GIL + AZA and 0.03 month for AZA (hazard ratio, 0.686; 95% CI, 0.433-1.087; P = .156). CRc rates were 58.1% (GIL + AZA) and 26.5% (AZA) (difference, 31.4%; 95% CI, 13.1-49.7; P < .001). Adverse event (AE) rates were similar for GIL + AZA (100%) and AZA (95.7%); grade ≥3 AEs were 95.9% and 89.4%, respectively. Common AEs with GIL + AZA included pyrexia (47.9%) and diarrhea (38.4%). Gilteritinib steady-state trough concentrations did not differ between GIL + AZA and gilteritinib. GIL + AZA resulted in significantly higher CRc rates, although similar OS compared with AZA. Results support the safety/tolerability and clinical activity of upfront therapy with GIL + AZA in older/unfit patients with FLT3mut+ AML. This trial was registered at www.clinicaltrials.gov as #NCT02752035.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.