This phase I trial studies the side effects and the best dose of selinexor when give together with standard chemotherapy, high dose cytarabine and mitoxantrone hydrochloride, in treating patients with acute myeloid leukemia. Selinexor may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cytarabine and mitoxantrone hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving selinexor together with standard chemotherapy may be a better treatment for patients with acute myeloid leukemia.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Given per standard of care
Given per standard of care
Given PO
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
MTD of selinexor based on the dose-limiting toxicity graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Time frame: 56 days
Allo-SCT success rate
Time frame: After completion of induction therapy (6 months to a year)
Incidence of adverse events graded according to NCI CTCAE version 4.03
Time frame: Up to 30 days post-treatment
Incidence of non-relapse mortality
Time frame: Up to 1 year
Overall survival (OS) rates
The median duration of OS will be estimated based on the 50th percentile of the Kaplan-Meier distribution; additional summary statistics will be presented, including the 25th and 75th percentiles, 95% CIs on the median and other percentiles, and proportion of censored data. Kaplan-Meier survival rates will also be calculated.
Time frame: Date induction chemotherapy to the date of disease relapse or death, assessed up to 1 year
Progression-free survival (PFS) rates
PFS will be estimated based on the 50th percentile of the Kaplan-Meier distribution; additional summary statistics will be presented, including the 25th and 75th percentiles, 95% confidence intervals (CIs) on the median and other percentiles, and proportion of censored data. Kaplan-Meier survival rates will also be calculated.
Time frame: Date induction chemotherapy to the date of disease relapse or death, assessed up to 1 year
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