ONC201 in Relapsed/Refractory Acute Leukemias and High-Risk Myelodysplastic Syndromes (HR-MDS)
Status:
Active, not recruiting
Trial end date:
2023-11-30
Target enrollment:
Participant gender:
Summary
The goal of Phase I of this clinical research study is to find the highest tolerable dose of
ONC201 alone or in combination with low dose cytarabine (LDAC) that can be given to patients
with relapsed or refractory AML, ALL, or MDS. The goal of Phase II of this study is to learn
if the dose of ONC201 given alone or in combination with LDAC that is found in Phase I can
help to control the disease.
The safety of the study drug will be studied in both phases of this study. This is the first
study using ONC201 in humans.
ONC201 given alone or in combination with LDAC is in a very early stage of development for
use in humans. Providing direct medical benefit to you is not the purpose of this study.
While Phase II will look at the effectiveness of the study drug given alone or in combination
with LDAC, the main purpose of this study is to learn about the safety of the drug.