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
Recruiting
Apply to this trial

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

Start date
Nov 14, 2022
Status verified
Jul 2024
Primary completion
Nov 30, 2025
Completion
Nov 30, 2025

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 ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
Banner MD Anderson Cancer CenterGilbertArizona85234
Rajneesh Nath, MD
[email protected]
+34 935151313
The University of Arizona Cancer Center - North CampusTucsonArizona85724-5024
Sharad Khurana, MD, MSc
[email protected]
+34935151313
Sharad Khurana, MD (PRINCIPAL_INVESTIGATOR)
Miami Cancer InstituteMiamiFlorida33176
Guenther Koehne, MD, PhD
[email protected]
+34 935151313
Sylvester Comprehensive Cancer CenterMiamiFlorida33136
Sangeetha Venugopal, MD
[email protected]
+34935151313
The John Hopkins University School of MedicineBaltimoreMaryland21287-0013
Alexander J Ambiender, MD
[email protected]
+34 935151313
Massachusetts General Hospital (MGH)BostonMassachusetts02114
Amir Fathi, MD
[email protected]
+34935151313
Rutgers, The State UniversityPiscatawayNew Jersey08854
Neil D Palmisiano, MD, MS
[email protected]
+34 935151313
Icahn School of Medicine at Mount Sinai and Mount Sinai HospitalNew YorkNew York10029
Jonathan Feld, MD
[email protected]
+34935151313
Duke University Medical CenterDurhamNorth Carolina27705
Harry P Erba, MD
[email protected]
+34935151313
Oregon Health & Science UniversityPortlandOregon97239
Theodore P Braun, MD PhD
[email protected]
+34 935151313
Sarah Cannon Research Institute, LLCNashvilleTennessee37203
Stephen Strickland, MD
[email protected]
+34935151313
West Virginia UniversityMorgantownWest Virginia26506
Konstantinos Sdrimas, MD
[email protected]
+34935151313
Froedtert Hospital & The Medical College of WisconsinMilwaukeeWisconsin53226
Guru SG Murthy, MD
[email protected]
+34935151313

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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