Selinexor With Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia



Status:Active, not recruiting
Conditions:Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:Any
Updated:6/13/2018
Start Date:October 7, 2015
End Date:January 2020

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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)

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.


Inclusion Criteria:

- Signed, written informed consent in accordance with federal, local, and institutional
guidelines

- Patients with newly diagnosed or relapsed/refractory AML, except acute promyelocytic
leukemia (APL), requiring intensive induction chemotherapy

- Eastern Cooperative Oncology Group (ECOG) performance status of =< 2

- Creatinine clearance > 30 cc/min calculated using the Cockcroft and Gault (1976)
formula or measured

- Total bilirubin =< 2 mg/dl unless high indirect bilirubin is due to a congenital
disorder

- Transaminases (aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) =<
3.0 x upper limit of normal (ULN) unless due to leukemia infiltration

- Prothrombin time (PT) and partial thromboplastin time (PTT) =< 2 x ULN

- Willingness and ability to comply with scheduled visits, treatment plans, laboratory
tests and other study procedures

- It is important patients understand the need to use birth control while on this study;
female patients of child-bearing potential must agree to use dual methods of
contraception and have a negative serum pregnancy test at screening (< 3 days prior to
first dose), male patients with partners of childbearing potential must agree to use
effective contraception during the study period and a period of 3 months after the
last dose of study drug; for both male and female patients, effective methods of
contraception must be used throughout the study and for three months following the
last dose

Exclusion Criteria:

- Treatment with any investigational agent within two weeks prior to first dose in this
study; hydroxyurea is allowed to control the AML prior to treatment on the study

- AML central nervous system (CNS) involvement

- Major surgery within 2 weeks of first dose of study drug; patients must have recovered
from the effects of any surgery performed greater than 2 weeks previously

- Patient has a concurrent advantage active malignancy under treatment

- Unstable cardiovascular function:

- Symptomatic ischemia, or

- Uncontrolled clinically significant conduction abnormalities (i.e., ventricular
tachycardia on antiarrhythmic agents are excluded; 1st degree atrioventricular
[AV] block or asymptomatic left anterior fascicular block/right bundle branch
block [left anterior fascicular block (LAFB)/right bundle branch block (RBBB)]
will not be excluded), or

- Congestive heart failure (CHF) New York Heart Association (NYHA) class >= 3, or

- Myocardial infarction (MI) within 3 months

- Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals
within one week prior to first dose; infections controlled on concurrent
anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional
guidelines is acceptable

- Known active hepatitis B virus (HBV) or C virus (HCV) infection; or known to be
positive for HCV ribonucleic acid (RNA) or HBsAg (HBV surface antigen)

- Known human immunodeficiency virus (HIV) infection

- Any medical condition which, in the investigator's opinion, could compromise the
patient's safety

- Patients unable to swallow tablets or patients with malabsorption syndrome, or any
other disease significantly affecting gastrointestinal function

- Seizure or cerebrovascular accident (CVA) in the last year
We found this trial at
1
site
5841 S Maryland Ave
Chicago, Illinois 60637
1-773-702-6180
Principal Investigator: Hongtao Liu
Phone: 773-834-0589
University of Chicago Comprehensive Cancer Center The University of Chicago Comprehensive Cancer Center (UCCCC) is...
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mi
from
Chicago, IL
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