Acute Myeloid Leukemia Clinical Trial
Study of Iadademstat and Gilteritinib in Patients With R/R AML With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+)
This is an escalation/expansion, open label, single arm, study to investigate the safety and the RP2D of the combination of iadademstat with gilteritinib in FLT3-mutated R/R AML.
This study consists of 2 parts. A dose finding part to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and emerging activity of iadademstat and gilteritinib combination, and to determine the pharmacologically-active dose (i.e., the minimum safe and biologically active dose) of iadademstat in combination with gilteritinib, and an expansion part at the specific dose/s selected to evaluate the activity of iadademstat in combination with gilteritinib in patients with FLT3-mutated R/R AML.
Main Inclusion Criteria:
Diagnosis of primary AML or AML with myelodysplasia-related changes (AML-MRC)
Patient is in first or second relapse or has refractory disease. Patients must have had histologic verification of AML at the original diagnosis.
Patient must be positive for the following FLT3 mutations in bone marrow or PB: FLT3 internal tandem duplication (ITD), FLT3 tyrosine kinase domain (TKD) D835 or I836 or FLT3-ITD and specified FLT3-TKD.
ECOG performance status 0-2
Life expectancy of at least 3 months in the opinion of the investigator.
Normal hepatic and renal function.
Patient is able to swallow oral medications.
Female patients are postmenopausal, documented as surgically sterile, use two methods of contraception or practice true abstinence and have a negative urine pregnancy test at screening.
Male patients even if surgically sterilized agree to practice true abstinence or use highly effective barrier contraception.
Main Exclusion Criteria:
Diagnosis of acute promyelocytic leukemia.
Known BCR-ABL-positive leukemia.
AML secondary to prior chemotherapy for other neoplasms (except for MDS).
AML that has relapsed after or is refractory to more than 2 lines of therapy.
Clinically active central nervous system leukemia or prior history of NCI CTCAE Grade ≥ 3 drug-related CNS toxicity.
Major surgery or radiation therapy within 4 weeks prior to the first study dose.
Prior treatment with iadademstat or FLT3 inhibitors (except sorafenib or midostaurin used in first line as part of induction).
Patients not eligible to receive gilteritinib per label.
Prior treatment with 3 or more lines of AML therapy.
Treatment with any investigational products within 3 weeks prior to first dose of study treatment.
Uncontrolled hypertension or poorly controlled diabetes.
Evidence of active uncontrolled viral, bacterial, or systemic fungal infection.
Pregnant or lactating women.
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