Acute Myeloid Leukemia (AML) Clinical Trial
Official title:
Phase I/II Study of IRX5183 in Relapsed and Refractory Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS)
The purpose of this study is to evaluate the use of IRX5183 in 1) patients with relapsed and/or refractory AML and 2) patients with high-risk MDS or chronic myelomonocytic leukemia (CMML).
This research is being done to learn about the safety and effectiveness of an investigational
drug, IRX5183, in treating acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).
IRX5183 is a derivative of Vitamin A. IRX5183 is a drug that is designed to cause cancer
cells to mature and then die. It is thought that it will stop the uncontrolled growth of
leukemia cells.
These are 2 parts to this study. The purpose of the first part is to test the safety of
IRX5183 at different dose levels. The investigators want to find out what effects, good
and/or bad, it has on AML or MDS. Once the investigators figure out the best and safest dose
of IRX5183, the investigators will enter the second part of the study using this dose. The
purpose of the second part is to see if IRX5183 is effective as a treatment for AML or MDS.
To date, IRX5183 has been used in about 25 people.
The first part of the study is called a "Phase I" study. Phase I studies use drugs starting
at low doses and slowly increase the amounts of the study drugs that are given to people
until the side effects of the drugs are too high to give more. This means that not all people
in the study will get the same dose of IRX5183. Doses at the beginning of the study will be
lower than doses at the end of the study. Because of the design of the study, some people may
get doses that are too low to have an effect, and other people will probably get doses that
cause side effects.
People with AML, MDS, or CMML that has 1) not responded to standard therapy or 2) has
returned after a previous response may join.
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