Actively Recruiting
Study of Iadademstat and Gilteritinib in Patients With R/R AML With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+)
Led by Oryzon Genomics S.A. · Updated on 2024-07-29
50
Participants Needed
13
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Iadademstat and Gilteritinib in Patients With R/R AML With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of primary AML or AML with myelodysplasia-related changes (AML-MRC)
- Patient is in first or second relapse or has refractory disease with histologic verification of AML at original diagnosis
- Positive for FLT3 mutations in bone marrow or peripheral blood: FLT3 internal tandem duplication (ITD), FLT3 TKD D835 or I836, or both
- ECOG performance status between 0 and 2
- Life expectancy of at least 3 months as judged by investigator
- Normal liver and kidney function
- Able to swallow oral medications
- Female patients must be postmenopausal, surgically sterile, use two contraception methods or practice true abstinence, and have a negative pregnancy test
- Male patients must agree to true abstinence or use effective barrier contraception
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia
- Known BCR-ABL-positive leukemia
- AML secondary to prior chemotherapy for other cancers (except MDS)
- AML refractory or relapsed after more than 2 therapy lines
- Active central nervous system leukemia or severe drug-related CNS toxicity history
- Major surgery or radiation within 4 weeks before first dose
- Prior iadademstat treatment
- Recent treatment with KDM1A/LSD1 inhibitors or investigational products within 3 weeks before first dose
- Ineligibility to receive gilteritinib per label
- More than 3 prior AML therapy lines
- Uncontrolled hypertension or poorly controlled diabetes
- Active uncontrolled infections
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Actively Recruiting
2
The University of Arizona Cancer Center - North Campus
Tucson, Arizona, United States, 85724-5024
Actively Recruiting
3
Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
4
Miami Cancer Institute
Miami, Florida, United States, 33176
Actively Recruiting
5
The John Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287-0013
Actively Recruiting
6
Massachusetts General Hospital (MGH)
Boston, Massachusetts, United States, 02114
Actively Recruiting
7
Rutgers, The State University
Piscataway, New Jersey, United States, 08854
Actively Recruiting
8
Icahn School of Medicine at Mount Sinai and Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
9
Duke University Medical Center
Durham, North Carolina, United States, 27705
Actively Recruiting
10
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
11
Sarah Cannon Research Institute, LLC
Nashville, Tennessee, United States, 37203
Actively Recruiting
12
West Virginia University
Morgantown, West Virginia, United States, 26506
Actively Recruiting
13
Froedtert Hospital & The Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
M
Mónica Reale-Vidal, MD
CONTACT
S
Sonia Gutiérrez, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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