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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-14

Study Completion Date

2025-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML)

NCT05756777

Acute Myeloid Leukemia (AML)

RECRUITING PHASE1

Expanded Access Study of Gilteritinib (ASP2215) in Patients With FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or FLT3-Mutated AML in Complete Remission (CR) With Minimal Residual Disease (MRD)

NCT03070093

Acute Myeloid Leukemia (AML) FMS-like Tyrosine Kinase-3 (FLT3) Mutations

APPROVED_FOR_MARKETING

A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation

NCT02421939

Leukemia, Acute Myeloid (AML)

COMPLETED PHASE3

Treatment Patterns and Key Healthcare Resource Use in Acute Myeloid Leukemia (AML) With or Without FMS-like Tyrosine Kinase-3 (FLT3) Mutation Study Based on Retrospective Chart Review

NCT03047083

Acute Myeloid Leukemia (AML)

COMPLETED

Efficacy of Gilteritinib in Combination With FLAI as Induction Therapy of FLT3-positive Acute Myeloid Leukemia

NCT06667973

Acute Myeloid Leukemia FLT3 Gene Mutation Adult AML +1 more

NOT_YET_RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is an escalation/expansion, open label, single arm, study to investigate the safety and the RP2D of the combination of iadademstat with gilteritinib in FLT3-mutated R/R AML.

This study consists of 2 parts. A dose finding part to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and emerging activity of iadademstat and gilteritinib combination, and to determine the pharmacologically-active dose (i.e., the minimum safe and biologically active dose) of iadademstat in combination with gilteritinib, and an expansion part at the specific dose/s selected to evaluate the activity of iadademstat in combination with gilteritinib in patients with FLT3-mutated R/R AML.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Myeloid Leukemia, in Relapse Acute Myeloid Leukemia Refractory

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Escalation/extension open label study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active arm

iadademstat and gilteritinib

Group Type EXPERIMENTAL

Iadademstat

Intervention Type DRUG

iadademstat oral solution

Gilteritinib Oral Tablet

Intervention Type DRUG

120 mg Gilteritinib

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Iadademstat

iadademstat oral solution

Intervention Type DRUG

Gilteritinib Oral Tablet

120 mg Gilteritinib

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ORY-1001, RO7051790 XOSPATA®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No