Gilteritinib for acute myeloid leukemia with an FLT3-ITD mutation and leftover cancer cells
Tests gilteritinib in adults with FLT3-ITD acute myeloid leukemia to clear remaining cells.
Plain-language title generated from the registry record
Registry title: Administration of Gilteritinib to eliminate MRD in patients with AML and FLT3-ITD mutation.
Key facts
- Where
- Athens, Chaïdári, and Thessaloniki, GreeceSee the 4 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 75 with newly diagnosed FLT3-ITD mutated acute myeloid leukemia who still have measurable residual disease after 2 cycles of intensive chemotherapy with an FLT3 inhibitor.
- Age
- 18 to 75 years
- Sex
- All sexes
- Disease stage
- New diagnosis of primary (de novo) FLT3-ITD mutated acute myeloid leukemia (AML), WHO 2017 criteria. Life expectancy over 3 months. ECOG performance status below 2. Body weight over 40 kg (88 lb).
- Earlier treatment
- Must have had 2 cycles of intensive chemotherapy together with an FLT3 inhibitor, and still have positive measurable residual disease (MRD).
- Biomarker or test result
- FLT3-ITD mutation. Positive MRD by PCR-NGS for FLT3-ITD after 2 cycles of intensive chemotherapy with an FLT3 inhibitor.
Main reasons for not taking part
- Secondary AML, including AML caused by earlier treatment or following another blood disorder (MDS, MPN)
- Acute promyelocytic leukemia
- HIV, or active hepatitis B or hepatitis C infection
- Pregnant or breastfeeding, or not willing to use effective contraception
- Malabsorption syndrome or another condition that prevents taking the drug by mouth
Read by machine on 9 November 2026.
Where in Greece
- Evaggelismos HospitalAthens, GreeceTaking people
- Laiko General Hospital of AthensAthens, GreeceTaking people
- University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"Chaïdári, GreeceTaking people
- Geniko Nosokomeio Thessalonikis George PapanikolaouThessaloniki, GreeceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorTrial details
- Who runs it
- Hellenic Society Of Hematology
- Trial code
- EU 2025-521875-30-00
- Record updated
- 12 October 2026
- Original description
To evaluate the efficacy of Gilteritinib treatment in eradication of measurable residual disease (MRD) by PCR-NGS for FLT3-ITD.Read full original descriptionShow less
An open-label, phase 2 study, evaluating the efficacy of treatment with Gilteritinib in measurable residual disease eradication in patients with FLT3-ITD mutated acute myeloid leukemia
To evaluate the efficacy of Gilteritinib treatment in eradication of measurable residual disease (MRD) by PCR-NGS for FLT3-ITD.
Inclusion: Patients must provide signed and dated informed consent for the study that has been approved by an Independent Ethics Committee (IEC) and the relevant Institution Review Board (IRB) of each participating centre, before performing any screening or study procedure; Female patients of reproductive potential using hormonal contraceptives should add a barrier method of contraception; Female subjects of child-bearing potential are eligible if they commit to contraception and if they are not pregnant, breastfeeding, nor considering becoming pregnant during the study or for at least 6 months after the last dose of Gilteritinib; If male, and subject is sexually active with female partner(s) of childbearing potential, he must agree, to use effective contraception during treatment and for at least 4 months after the last dose of Gilteritinib; Subjects must be willing and able to return to the clinical site for adequate follow-up and to comply with the protocol as required; Patients with positive MRD (by PCR-NGS for FLT3-ITD) after 2 cycles of intensive chemotherapy in combination with an FLT3- inhibitor will be eligible for enrolment; Adult male or female patients.. Aged 18 – 75 years old on the day of signing informed consent; Subjects must have a new diagnosis of primary/de novoFLT3-ITD mutated AML according to the WHO criteria (2017); Body weight >40kg; Subjects must be willing and able to comply with the relevant procedures, according to the protocol; Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of < 2 (See Appendix 1: ECOG Performance Status); Subjects must have an estimated life expectancy of >3 months; Female patients of childbearing potential: negative serum pregnancy test at the screening visit and negative urine pregnancy test within seven days prior to starting treatment with Gilteritib; Female patients of reproductive potential must agree to use an effective method of contraception during treatment with Gilteritinib and for at least 6 months after stopping Gilteritinib.
Exclusion: Subjects with secondary AML, including treatment-related [e.g., due to prior anthracycline use], as well as subjects with progression of antecedent hematological disorder [e.g., MDS, MPN or MDS/MPN ‘overlap’ syndrome]; Subjects with a serious concurrent illness that in the opinion of the Investigator would pose an undue risk to the subject participating in the clinical study (such as active/uncontrolled infection at the time of screening); History of clinically significant medical conditions or any other reason that the investigator determines would interfere with the subject's participation in this study or would make the subject an unsuitable candidate to receive study drug; Subjects with a diagnosis of human immunodeficiency virus (HIV), active hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection. Subjects with HBV inactive carrier status and/or HCV with low viral titres on antivirals (non-exclusionary medications) are eligible. Low viral hepatitis titre is defined per institutional guidelines; Known hypersensitivity to the active substance or to any of the excipients of Gilteritinib; Has a known psychiatric or substance abuse disorder that would interfere with the participant’s ability to cooperate with the requirements of the study; Malabsorption syndrome or other condition that precludes oral route of administration; Subjects with acute promyelocytic leukemia; Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of Gilteritinib; Patients not willing to comply with effective contraception.