The FRIDA Study (Relapsed or Refractory Acute Myeloid Leukemia)

Purpose of this Study

We are doing this study to find the most effective, safe dose of an experimental drug called iadademstat (the study drug). We want to know if the study drug is beneficial for people with R/R AML that have the FLT3 mutation when it is given in combination with gilteritinib.

Who Can Participate?

Eligibility

Adults ages 18+ who:
  • Are diagnosed with primary AML or AML with myelodysplasia related changes
  • Have relapsed from previous treatment or have cancer that is not responding to current treatment
  • Are positive for FLT3 mutations in the bone marrow
  • Do not have a diagnosis of acute promyelocytic leukemia
  • Do not have BCR-ABL positive leukemia
For more information about who can join this study, please contact the study team at 919-660-7262.

What is Involved?

Description

If you choose to join this study, you will go through a screening period to find out if you are eligible. During this screening period, you will:
  • Have a physical exam
  • Have a heart scan (ECG)
  • Have blood draws
  • Have a bone marrow biopsy and/or aspiration
If you are eligible, you will proceed to the study drug period. During this part of the study, you will take both gilteritinib (tablets by mouth) and iadademstat (liquid by mouth) at the same time each day. You will have the following tests and procedures during the course of the study:
  • Physical exams
  • Blood tests
  • ECG
  • Bone marrow biopsy and/or aspiration
You will take the study regimen until the study doctor determines that it is no longer necessary or you are no longer receiving a benefit. After you stop taking the study drugs, you will come in for a follow-up visit and we will keep in touch with you for about a year.

Study Details

Full 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

Principal Investigator

Harry
Erba

Protocol Number

PRO00113157

NCT ID

NCT05546580

Phase

I

Enrollment Status

Open to Enrollment
ClinicalTrials.gov