Selinexor With Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT02573363|
Recruitment Status : Active, not recruiting
First Posted : October 9, 2015
Last Update Posted : June 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Drug: Cytarabine Drug: Mitoxantrone Hydrochloride Drug: Selinexor||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Investigator Sponsored Study to Assess the Tolerability and Efficacy of Selinexor in Combination With High Dose Cytarabine (HiDAC) and Mitoxantrone Chemotherapy for Remission Induction in Acute Myelogenous Leukemia (AML)|
|Actual Study Start Date :||October 7, 2015|
|Actual Primary Completion Date :||January 1, 2018|
|Estimated Study Completion Date :||January 2020|
Experimental: selinexor, cytarabine, and mitoxantrone
INDUCTION CHEMOTHERAPY: Patients receive high-dose cytarabine and mitoxantrone hydrochloride per standard of care on days 1 and 5, and selinexor PO on days 2, 4, 9, and 11.
CONSOLIDATION CHEMOTHERAPY: Patients receive high-dose cytarabine per standard of care on days 1, 3, and 5, and selinexor PO on days 2, 4, 9, and 11. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE CHEMOTHERAPY: Patients achieving at least stable disease after consolidation chemotherapy may receive selinexor PO on days 1, 8, 15, and 22 at the discretion of principal investigator.
Given per standard of care
Other Name: Ara-C
Drug: Mitoxantrone Hydrochloride
Given per standard of care
Other Name: Mitroxone
Other Name: KPT-330
- 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 [ Time Frame: Date induction chemotherapy to the date of disease relapse or death, assessed up to 1 year ]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.
- Progression-free survival (PFS) rates [ Time Frame: Date induction chemotherapy to the date of disease relapse or death, assessed up to 1 year ]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.
- MRD status as measured by WT1 transcript levels using quantitative real time-PCR [ Time Frame: Up to 1 year ]Cox models may be used to determine MRD status during the treatment course.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02573363
|United States, Illinois|
|University of Chicago Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Hongtao Liu||University of Chicago Comprehensive Cancer Center|