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

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Oryzon Genomics S.A.
Study ID
NCT05546580
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Acute Myeloid Leukemia Refractory
  • Acute Myeloid Leukemia, in Relapse

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Iadademstat — DRUG
    iadademstat oral solution
  • Gilteritinib Oral Tablet — DRUG
    120 mg Gilteritinib

Study Details

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.

Key Dates

First listed
Sep 21, 2022
Start date
Nov 14, 2022
Status verified
Aug 2026
Primary completion
Jan 30, 2026
Completion
Dec 5, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Active arm
    iadademstat and gilteritinib

Primary Outcome Measure

Adverse Events (AE) [ Time Frame: Up to 18 months ]

Locations (13)

FacilityCityStateZIPSite coordinators
Banner MD Anderson Cancer CenterGilbertArizona85234-
The University of Arizona Cancer Center - North CampusTucsonArizona85724-5024-
Miami Cancer InstituteMiamiFlorida33176-
Sylvester Comprehensive Cancer CenterMiamiFlorida33136-
The John Hopkins University School of MedicineBaltimoreMaryland21287-0013-
Massachusetts General Hospital (MGH)BostonMassachusetts02114-
Rutgers, The State UniversityPiscatawayNew Jersey08854-
Icahn School of Medicine at Mount Sinai and Mount Sinai HospitalNew YorkNew York10029-
Duke University Medical CenterDurhamNorth Carolina27705-
Oregon Health & Science UniversityPortlandOregon97239-
Sarah Cannon Research Institute, LLCNashvilleTennessee37203-
West Virginia UniversityMorgantownWest Virginia26506-
Froedtert Hospital & The Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Gilbert, AZ

By research site
Banner MD Anderson Cancer Center· Gilbert, AZThe University of Arizona Cancer Center - North Campus· Tucson, AZMiami Cancer Institute· Miami, FLSylvester Comprehensive Cancer Center· Miami, FLThe John Hopkins University School of Medicine· Baltimore, MDMassachusetts General Hospital (MGH)· Boston, MA

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