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New treatment option for Acute Myeloid Leukemia, in Relapse
Official title Study of Iadademstat and Gilteritinib in Patients With R/R AML With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+)
ClinicalTrials.gov ID: NCT05546580
What this study is testing
What is Iadademstat?
Iadademstat is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for acute myeloid leukemia, in relapse.
Also referred to as ORY-1001, RO7051790.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Main
- 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...
- ECOG performance status 0-2
You likely can't join if
- 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.
See the full eligibility criteria
- Main
- 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
- 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 is not allowed. Treatment with any other agents with KDM1A/LSD1 inhibitory activity is only allowed if treatment finalized at least 3 weeks prior to first dose on study. Previous...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Gilbert, Arizona, United States
- Tucson, Arizona, United States
- Miami, Florida, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Piscataway, New Jersey, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Portland, Oregon, United States
- Nashville, Tennessee, United States
- Morgantown, West Virginia, United States
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gilbert, Arizona, United States; Tucson, Arizona, United States; Miami, Florida, United States; Baltimore, Maryland, United States; Boston, Massachusetts, United States; Piscataway, New Jersey, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.