Clinical Trials in the USA / NCT05546580
Active, not recruiting
Phase 1
Study of Iadademstat and Gilteritinib in Patients With R/R AML With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+)
NCT05546580 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Acute Myeloid Leukemia, in RelapseAcute Myeloid Leukemia Refractory
Investigational drug(s) / intervention(s)
IadademstatGilteritinib Oral Tablet →
Iadademstat: iadademstat oral solution
Gilteritinib Oral Tablet: 120 mg Gilteritinib
Study summary
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
Main Inclusion Criteria:
* 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 Exclusion Criteria:
* 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 treatment with FLT3 inhibitors is allowed in the following cases: midostaurin and sorafenib are allowed when used in first-line therapy regimen as part of induction, consolidation and/or maintenance: quizartinib and gilteritinib are allowed when used in first-line therapy regimen, as part of induction, consolidation and/or maintenance, ONLY if patients were not refractory to the drugs or if responding, relapse did not occur while on these drugs.
* 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.
Primary outcome measure(s)
- Adverse Events (AE) — Up to 18 months
Number of participants with Adverse Events (AE) after treatment with iadademstat in combination with gilteritinib in patients with FLT3-mutated R/R AML. - Laboratory value abnormalities and/or adverse events (AE) — Up to 18 months
Number of participants with laboratory value abnormalities and/or Adverse Events (AE) after treatment with iadademstat in combination with gilteritinib in patients with FLT3-mutated R/R AML. - Vital sign abnormalities and/or adverse events (AEs) — Up to 18 months
Number of participants with vital signs abnormalities and/or Adverse Events (AE) after treatment with iadademstat in combination with gilteritinib in patients with FLT3-mutated R/R AML. - Routine 12-lead electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs) — Up to 18 months
Number of participants with Routine 12-lead electrocardiogram (ECG )abnormalities and/or Adverse Events (AE) after treatment with iadademstat in combination with gilteritinib in patients with FLT3-mutated R/R AML. - Recommend Phase 2 dose (RP2D) — Up to 18 months
Determine the recommended Phase 2 dose (RP2D) of iadademstat in combination with gilteritinib in patients with FLT3-mutated R/R - iadademstat tmax — Up to 26 days
Measurement of the time it takes for iadademstat to reach the maximum concentration (Cmax) in blood. - Iadademstat Cmax — Up to 26 days
Measurement of the highest concentration of iadademstat in the blood after a dose is given. - iadademstat Cmin — Up to 26 days
Measurement of the lowest concentration of iadademstat in the blood, after a dose is given. - iadademstat AUC — Up to 26 days
Measurement of how much iadadmestat reaches a person's bloodstream in a given period of time after a dose is given. - iadademstat Target Engagement (TE) — Up to 26 days
Percent of drug covalently bound to LSD1 molecule - OR rate — Up to 18 months
Proportion of patients achieving complete remission (CR), CR with incomplete hematologic recovery (CRi), and partial remission (PR).
Trial sites (13)
| Facility | City | Region | Status |
|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | |
| The University of Arizona Cancer Center - North Campus | Tucson | Arizona | |
| Sylvester Comprehensive Cancer Center | Miami | Florida | |
| Miami Cancer Institute | Miami | Florida | |
| The John Hopkins University School of Medicine | Baltimore | Maryland | |
| Massachusetts General Hospital (MGH) | Boston | Massachusetts | |
| Rutgers, The State University | Piscataway | New Jersey | |
| Icahn School of Medicine at Mount Sinai and Mount Sinai Hospital | New York | New York | |
| Duke University Medical Center | Durham | North Carolina | |
| Oregon Health & Science University | Portland | Oregon | |
| Sarah Cannon Research Institute, LLC | Nashville | Tennessee | |
| West Virginia University | Morgantown | West Virginia | |
| Froedtert Hospital & The Medical College of Wisconsin | Milwaukee | Wisconsin |
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05546580 on ClinicalTrials.gov ↗ ← All trials in the USA