Purpose of this Study
We are doing this study to find out if an experimental drug called KO-539 (study drug) is a safe and effective treatment for AML. We want to know if it might be beneficial for people with AML that is resistant to standard treatments.
Who Can Participate?
Eligibility
Adults ages 18+ who have AML that is not responding to standard therapies.
For more information about who can join this study, please contact the study team at 919-660-2077.
For more information about who can join this study, please contact the study team at 919-660-2077.
What is Involved?
If you choose to join this study, you will take the study drug by mouth each day. This drug is taken once a day continuously in 28-day cycles.
Your study doctor will assess how you are doing at the end of each drug cycle. How many drug cycles you do will depend on:
- How well you tolerate the study drug
- How well your cancer responds to the drug
- Your overall health
When you stop taking the study drug, we will follow up with you each month either over the phone or in the clinic to see how you are doing. This monthly follow-up may continue for up to 6 months.
Your study doctor will assess how you are doing at the end of each drug cycle. How many drug cycles you do will depend on:
- How well you tolerate the study drug
- How well your cancer responds to the drug
- Your overall health
When you stop taking the study drug, we will follow up with you each month either over the phone or in the clinic to see how you are doing. This monthly follow-up may continue for up to 6 months.
Study Details
Full Title
A Phase 1/2A First in Human Study of the Menin-MLL(KMT2A) Inhibitor
KO-539 in Patients with Relapsed or Refractory Acute Myeloid Leukemia
KO-539 in Patients with Relapsed or Refractory Acute Myeloid Leukemia
Principal Investigator
Harry
Erba
Protocol Number
PRO00106997
NCT ID
NCT04067336
Phase
I/II
Enrollment Status
OPEN TO ACCRUAL