NCT07425808Not yet recruitingPhase 2/3

FLT3-ITD Targeted Therapy in Fit AML Patients

Gilteritinib in Combination With Azacitidine and Venetoclax Compared to Induction Chemotherapy "7+3" in Combination With a FLT3-inhibitor in Fit, Newly Diagnosed, FLT3-ITD Mutated Adult AML Patients: a Randomized Trial of the EORTC Leukemia Group and GIMEMA.

Source: ClinicalTrials.gov · Last updated 23 Feb 2026

Brief summary (registry, in English)

This international, multicenter, randomized (1:1), open-label phase II/III trial will evaluate the efficacy and safety of gilteritinib combined with azacitidine and venetoclax (experimental arm) versus standard "7+3" induction plus a FLT3inhibitor (quizartinib or midostaurin) (control arm) in newly diagnosed FLT3-ITD mutated AML patients eligible for intensive chemotherapy.

Status (registry): Not yet recruiting
Phase (registry): Phase 2/3
Study type: Interventional
Enrollment: 230 (estimated)
First submitted: 12 Feb 2026
Start date: 1 Dec 2026
Primary completion date: 1 Oct 2028
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Diseases: Acute myeloid leukemia
NCT number: NCT07425808

What you commit to

Study type: Interventional · Phase 2/3
Planned participants: 230
From 1 Dec 2026 to the primary completion date, 1 Oct 2028
No sites listed in no country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Newly diagnosed AML cytopathologically confirmed according to the 5th WHO classification
Age between 18 and 75 years
FLT3-ITD mutation as per local IVDR-compliant testing. Positivity is defined as a FLT3-ITD / FLT3-wild type (WT) ratio of ≥ 0.05 (5%))
Eligibility for standard induction chemotherapy
ECOG PS ≤ 2
WBC ≤25 x 10\^9/L (hydroxyurea, leukapheresis or cytarabine in specific clinical circumstances, are allowed to meet this criterion. Please refer to Section 4.1.1 - Inclusion Criteria).
Adequate hepatic function (as indicated by total serum bilirubin level ≤2.5 x the institutional upper limit of normal range (UNL), unless due to Gilbert's syndrome, hemolysis or the underlying leukemia approved by the investigator; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤3 x UNL)
Adequate renal function as defined by an eGFR ≥ 30 mL/min according to the 2021 CKD-EPI equation
- Main Exclusion Criteria:
Acute promyelocytic leukemia (APL)
BCR-ABL positive leukemia or Ph1-positive chronic myeloid leukemia
History of myeloproliferative neoplasm (MPN), including myelofibrosis, essential thrombocythemia, polycythemia vera
Active central nervous system involvement by AML
Active, uncontrolled infection (viral, bacterial or fungal): an infection controlled with an approved or closely monitored antibiotic/antifungal treatment is allowed.
HIV, HBV or HCV active infection
Grade \>3 CTCAE (v. 6) clinically relevant (as per local investigator) adverse events at the time of enrolment
Prior treatment for myelodysplastic syndrome (MDS) with Venetoclax or hypomethylating agents (decitabine, azacitidine).
Any prior AML therapies (except for emergency treatment with hydroxyurea or cytarabine for hyperleukocytosis) Note: Subjects who undergo diagnostic workup for APL and treatment with all-trans retinoic acid, but who are found not to have APL, are eligible (treatment with all-trans retinoic acid must be discontinued before starting induction chemotherapy).
Any prior treatment with a FLT3 inhibitor
Serious organ dysfunction as left ventricular ejection fraction \<40%, FEV1, FVC, DLCO (diffusion capacity) \<40% of predicted
Cardiovascular disability status of New York Heart Association class ≥ 2
Congenital long QT syndrome or QT Interval Corrected Using Fridericia's Formula (QTcF) \>450 msec Note: repeat electrocardiograms after correction of electrolytes or discontinuation of QT prolonging medications are allowed to meet entry criteria. In cases where QTcF \>450 msec is considered to be falsely increased due to inaccurate automated reading and not clinically significant (e.g. due to bundle branch block), patients are still eligible if cardiologist reviews and documents that QTcF is ≤ 450 msec when manually measured.
Participant with a prior or concurrent malignancy or autoimmune disease requiring immunosuppressive therapy.
- Note: diseases whose natural history or treatment is not anticipated to interfere with the safety or efficacy assessment of the investigational regimen may be included only after discussion with the 2467 medical monitor and the study coordinator.
Consumed strong or moderate inducers of Cytochrome P450, family 3, subfamily A (CYP3A) or p-glycoprotein within 14 days of study enrolment or requiring treatment with such a medication during the trial.
Inability to swallow and/or any gastrointestinal disorders, malabsorption or other abnormalities that would interfere with absorption of the oral study drug.
Other life-threatening concurrent disease.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.