Selinexor in Combination With Fludarabine and Cytarabine in Patients With Refractory or Relapsed Acute Myeloid Leukemia

Exclusion Criteria

• •History of cerebellar toxicity or cerebellar neurological findings on exam.
• •Must not be pregnant or breastfeeding. Female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential. Acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal. For both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose.
• •Use of investigational agents, with the exception of gemtuzumab ozogamicin, within 30 days.
• •Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, study participation, follow up, or interpretation of study research.
• •Unstable cardiovascular function:
• •* symptomatic ischemia
• •* congestive heart failure NYHA Class \> 3
• •* 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 are acceptable.
• •Known human immunodeficiency virus (HIV) infection (pre-study testing not required).
• •Patients with malabsorption syndrome, or any other disease significantly affecting gastrointestinal function.
• •Prior treatment with selinexor.