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

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.

Conditions

Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia Refractory

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Acute Myeloid Leukemia, in Relapse
Intervention / Treatment

-

Contacts and Locations

Gilbert

Banner MD Anderson Cancer Center, Gilbert, Arizona, United States, 85234

Tucson

The University of Arizona Cancer Center - North Campus, Tucson, Arizona, United States, 85724-5024

Miami

Sylvester Comprehensive Cancer Center, Miami, Florida, United States, 33136

Miami

Miami Cancer Institute, Miami, Florida, United States, 33176

Baltimore

The John Hopkins University School of Medicine, Baltimore, Maryland, United States, 21287-0013

Boston

Massachusetts General Hospital (MGH), Boston, Massachusetts, United States, 02114

Piscataway

Rutgers, The State University, Piscataway, New Jersey, United States, 08854

New York

Icahn School of Medicine at Mount Sinai and Mount Sinai Hospital, New York, New York, United States, 10029

Durham

Duke University Medical Center, Durham, North Carolina, United States, 27705

Portland

Oregon Health & Science University, Portland, Oregon, United States, 97239

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Oryzon Genomics S.A.,

Mónica Reale-Vidal, MD, STUDY_CHAIR, Oryzon Genomics

Study Record Dates

2025-11-30