RECRUITING

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

Conditions

Acute Myeloid Leukemia, in Relapse Acute Myeloid Leukemia Refractory Acute Myeloid Leukemia, FLT3 mut

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

An Escalation/Expansion, Open Label, Multicenter Study of Iadademstat and Gilteritinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML) With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+): The FRIDA Study

Quick Facts

Study Start:2022-11-14

Study Completion:2025-11-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05546580

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Mónica Reale-Vidal, MD

CONTACT

+34 935151313

FRIDA_queries@oryzon.com

Sonia Gutiérrez, MSc

CONTACT

+34 935151313

FRIDA_queries@oryzon.com

Principal Investigator

Mónica Reale-Vidal, MD

STUDY_CHAIR

Oryzon Genomics

Study Locations (Sites)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234

United States

The University of Arizona Cancer Center - North Campus

Tucson, Arizona, 85724-5024

United States

Sylvester Comprehensive Cancer Center

Miami, Florida, 33136

United States

Miami Cancer Institute

Miami, Florida, 33176

United States

The John Hopkins University School of Medicine

Baltimore, Maryland, 21287-0013

United States

Massachusetts General Hospital (MGH)

Boston, Massachusetts, 02114

United States

Rutgers, The State University

Piscataway, New Jersey, 08854

United States

Icahn School of Medicine at Mount Sinai and Mount Sinai Hospital

New York, New York, 10029

United States

Duke University Medical Center

Durham, North Carolina, 27705

United States

Oregon Health & Science University

Portland, Oregon, 97239

United States

Sarah Cannon Research Institute, LLC

Nashville, Tennessee, 37203

United States

West Virginia University

Morgantown, West Virginia, 26506

United States

Froedtert Hospital & The Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Oryzon Genomics S.A.

Mónica Reale-Vidal, MD, STUDY_CHAIR, Oryzon Genomics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-14

Study Completion Date2025-11-30

Study Record Updates

Study Start Date2022-11-14

Study Completion Date2025-11-30

Terms related to this study

Keywords Provided by Researchers

Acute Myeloid Leukemia, FLT3 mut

Additional Relevant MeSH Terms

Acute Myeloid Leukemia, in Relapse
Acute Myeloid Leukemia Refractory