Study of Iadademstat and Gilteritinib in Patients With R/R AML With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+)

ID#: NCT05546580

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 1

Recruitment Status: Recruiting

Start Date: November 14, 2022

End Date: July 30, 2025

Contact Information:
Ana Limón, PhD
+34 935151313
Sonia Gutiérrez, MSc
+34 935151313
Summary: Iadademstat is being studied as a treatment for subjects with Relapsed or Refractory Acute Myeloid Leukemia (R/R AML) with FMS-like tyrosine kinase mutation (FLT3 mut+). During the trial, iadademstat will be given in combination with gilteritinib, a drug that is already approved to treat patients with FLT3-mutated R/R AML.
Eligibility: 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.