Study of Iadademstat and Gilteritinib in Patients With R/R AML With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorOryzon Genomics S.A.
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Iadademstat
- Gilteritinib Oral Tablet
Treatment groups
50 Participants
are divided into 1 treatment groupLocations
13Arizona
Banner MD Anderson Cancer Center85234, Gilbert United States
The University of Arizona Cancer Center - North Campus85724-5024, Tucson United States
Florida
Miami Cancer Institute33176, Miami United States
Sylvester Comprehensive Cancer Center33136, Miami United States
Sponsors and collaborators
Oryzon Genomics S.A.
Lead sponsor
Source ClinicalTrials.gov