Efficacy of Gilteritinib in Combination With FLAI as Induction Therapy of FLT3-positive Acute Mye… (NCT06667973) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Efficacy of Gilteritinib in Combination With FLAI as Induction Therapy of FLT3-positive Acute Myeloid Leukemia
80 participantsStarted 2025-06
Plain-language summary
The goal of this clinical trial is to evaluate the efficacy of gilteritinib as induction therapy in FLT3-positive adult acute myeloid leukemia patients. The main question it aims to answer is:
Is gilteritinib in combination to chemotherapy able to improve the complete remission rate of FLT3-positive AML?
Participants will receive up to 2 induction cycles with gilteritinib in combination with FLAI (fludarabine, cytarabine, idarubicine) and up to 3 consolidation cycles with gilteritinib and high-dose cytarabine.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. The patient is ≥ 18 and ≤65 years old.
✓. The patient has an Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 0 to 2.
✓. The patient has adequate baseline organ function, including cardiac, renal, and hepatic function:
✓. Left ventricular ejection fraction (LVEF) ≥institutional lower limit of normal as measured by multigated acquisition (MUGA) scan or 2-dimensional (2-D) echocardiography (ECHO) within 21 days before start of therapy and no clinically significant abnormalities on a 12-lead electrocardiogram (ECG).
✓. ECG: QTcF≤450 male ≤480 female
✓. Serum creatinine ≤ 1.5 x ULN or an estimated glomerular filtration rate of \> 50 mL/min as calculated by the Modification of Diet in Renal Disease equation.
✓. Bilirubin ≤3 times the upper limit of normal ULN mg/dL except for Gilbert's condition
✓. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 times the upper limit of normal (ULN)., except if due to leukemic involvement.
Exclusion criteria
✕. Patient was diagnosed as acute promyelocytic leukemia.
✕. Patient has BCR-ABL-positive leukemia or chronic myelogenous leukemia in blast crisis.
✕. Patient has clinically active central nervous system leukemia.
What they're measuring
1
Complete remission rate after induction
Timeframe: 2 months
Trial details
NCT IDNCT06667973
SponsorGruppo Italiano Malattie EMatologiche dell'Adulto
. Patient has been diagnosed with another malignancy, unless disease-free for at least 3 years. Subjects with treated nonmelanoma skin cancer, in situ carcinoma or cervical intraepithelial neoplasia, papillary thyroid carcinoma, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed. Subjects with organ-confined prostate cancer with no evidence of recurrent or progressive disease are eligible if hormonal therapy has been initiated or the malignancy has been surgically removed or treated with definitive radiotherapy.
✕. Patient has had major surgery within 4 weeks prior to the first study dose.
✕. Patient has radiation therapy within 4 weeks prior to the first study dose.
✕. Patient has congestive heart failure New York Heart Association (NYHA) class 3 or 4 or patient with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram performed within 1 month prior to study entry results in a left ventricular ejection fraction that is ≥ 45%.
✕. Patient has an active uncontrolled infection.