An Escalation/Expansion, Open Label, Multicenter Study of Iadademstat and Gilteritinib in Patients with Relapsed or Refractory Acute Myeloid Leukemia (R/R AML) with FMS-Like Tyrosine Kinase Mutation (FLT3 mut+): The FRIDA Study.
Primary Objectives:
- To evaluate the safety and tolerability of iadademstat in combination with gilteritinib in patients with FLT3-mutated R/R AML.
- To determine the recommended Phase 2 dose (RP2D) of iadademstat in combination with gilteritinib in patients with FLT3-mutated R/R AML
Secondary Objective:
- To evaluate the activity of iadademstat in combination with gilteritinib at the selected expansion dose/s in FLT3-mutated R/R AML.
Ladademstat
- Rutgers Cancer Institute of New Jersey
- Principal Investigator
- Neil Palmisiano MD
- Principal Investigator
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.
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.