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:<ul>
<li>Are diagnosed with primary AML or AML with myelodysplasia related changes</li>
<li>Have relapsed from previous treatment or have cancer that is not responding to current treatment</li>
<li>Are positive for FLT3 mutations in the bone marrow</li>
<li>Do not have a diagnosis of acute promyelocytic leukemia</li>
<li>Do not have BCR-ABL positive leukemia</li></ul>
For more information about who can join this study, please contact the study team at 919-660-7262.
<li>Are diagnosed with primary AML or AML with myelodysplasia related changes</li>
<li>Have relapsed from previous treatment or have cancer that is not responding to current treatment</li>
<li>Are positive for FLT3 mutations in the bone marrow</li>
<li>Do not have a diagnosis of acute promyelocytic leukemia</li>
<li>Do not have BCR-ABL positive leukemia</li></ul>
For more information about who can join this study, please contact the study team at 919-660-7262.
What is Involved?
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:<ul>
<li>Have a physical exam</li>
<li>Have a heart scan (ECG)</li>
<li>Have blood draws</li>
<li>Have a bone marrow biopsy and/or aspiration</li></ul>
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:<ul>
<li>Physical exams</li>
<li>Blood tests</li>
<li>ECG</li>
<li>Bone marrow biopsy and/or aspiration</li></ul>
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.
<li>Have a physical exam</li>
<li>Have a heart scan (ECG)</li>
<li>Have blood draws</li>
<li>Have a bone marrow biopsy and/or aspiration</li></ul>
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:<ul>
<li>Physical exams</li>
<li>Blood tests</li>
<li>ECG</li>
<li>Bone marrow biopsy and/or aspiration</li></ul>
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