Clinical trial NCT02299518 (phase 1, status: completed)
Conditions: adult acute myeloid leukemia with 11q23 (mll) abnormalities, adult acute myeloid leukemia with del(5q), adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), recurrent adult acute myeloid leukemia, secondary acute myeloid leukemia
ICD codes: R19.5, H35.09, M26.50, M26.59, Q99.8, R06.89, R06.9, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2, D75.1, E26.1, N91.1, N91.4, N94.5, A51.41, A51.43
Drugs: mitoxantrone hydrochloride, etoposide, cytarabine, selinexor
SMILES: OCCNCCNC1=CC=C(NCCNCCO)C2=C1C(=O)C1=C(C(O)=CC=C1O)C2=O, OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1, ClCCN(CCCl)P1(=O)NCCCO1, FC(F)(F)C1=CC(=CC(=C1)C1=NN(\C=C/C(=O)NNC2=NC=CN=C2)C=N1)C(F)(F)F
Eligibility criteria:

        Inclusion Criteria:

          -  Patients with relapsed or refractory AML; Cohort A patients must be < 60 years of age
             and have failed at least one prior induction regimen for AML; Cohort B patients must
             be ≥ 60 years of age, unfit for intensive therapy (physician opinion), and have failed
             an induction regimen for AML. The maximum number of prior lines of induction for both
             cohorts is 3

          -  Patients with secondary AML or therapy related disease (t-AML) are eligible

          -  If the patient has co-morbid medical illness, life expectancy attributed to this must
             be greater than 6 months

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

          -  Total bilirubin < 2.0 mg/dL, except when patient is known to have Gilbert's Syndrome,
             the total bilirubin can be ≤3.0 mg/dL.

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
             < 2.5 X institutional upper limit of normal

          -  Creatinine (Cr) clearance > 50 mL/min by Modification of Diet in Renal Disease (MDRD)
             calculation

          -  New York Heart Association (NYHA) congestive heart failure (CHF) class II or better

          -  Cardiac ejection fraction >= 50%

          -  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

          -  Ability to understand and willingness to sign the written informed consent document

        Exclusion Criteria:

          -  Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for
             nitrosoureas or mitomycin C) prior to entering the study

          -  Patients receiving any other investigational agents or patients that have received
             other investigational agents within 14 days of enrollment

          -  Patients with active central nervous system (CNS) malignancy; asymptomatic small
             lesions are not considered active; treated lesions may be considered inactive if they
             are stable for at least 3 months; patients with malignant cells in their cerebrospinal
             fluid (CSF) without CNS symptoms may be included

          -  Major surgery within 2 weeks before day 1

          -  Uncontrolled active infection; patients with infection requiring parenteral
             antibiotics are eligible if the infection is controlled

          -  Patients with significantly diseased or obstructed gastrointestinal tract or
             uncontrolled vomiting or diarrhea

          -  History of seizures, movement disorders or cerebrovascular accident within the past 3
             years prior to cycle 1 day 1

          -  Patients with macular degeneration, uncontrolled glaucoma, or markedly decreased
             visual acuity

          -  Uncontrolled intercurrent illness including, but not limited to, symptomatic
             congestive heart failure (New York Heart Association [NYHA) class III or IV), unstable
             angina pectoris, myocardial infarction within 6 months prior to enrollment, severe
             uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute
             ischemia or active conduction system abnormalities; prior to study entry, any
             electrocardiogram (ECG) abnormality at screening has to be documented by the
             investigator as not medically relevant

          -  Patients with serious medical or psychiatric illness likely to interfere with
             participation in this clinical study

          -  Pregnant women or women who are breastfeeding are excluded from this study;
             confirmation that the subject is not pregnant must be established by a negative serum
             beta (β)-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during
             screening; pregnancy testing is not required for post-menopausal or surgically
             sterilized women

          -  Patients with advanced malignant solid tumors

          -  Patients whom, in the opinion of the investigators, are significantly below their
             ideal body weight

          -  Patients who are not able to swallow capsules or tablets