Decitabine and Selinexor in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Completed · Phase 1

Conditions studied: Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia

In brief

This phase I trial studies the side effects and best dose of Selinexor when given together with decitabine in treating patients with acute myeloid leukemia that has returned after treatment (relapsed) or does not respond to treatment (refractory). Drugs used in chemotherapy, such as decitabine and Selinexor, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

Key facts

Study ID: NCT02093403
Run by: Bhavana Bhatnagar
People needed: 25
Starts: 2014-03-01
Expected to finish: 2016-11-26
Last updated by the study team: 2017-12-08

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients with relapsed or refractory AML
Newly diagnosed elderly AML patients (> 60 years) unfit for intensive chemotherapy with cytarabine and anthracyclines are also eligible to this trial given that no clinically beneficial therapy exists for these patients
Patients with secondary AML or therapy related disease (t-AML) are eligible; patients who received decitabine or 5-azacytidine as prior treatment for myelodysplastic syndrome (MDS) or AML remain eligible; however, none of these agents is permitted within 6 months of study entry
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
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 < 2.0 mg/d
Glomerular filtration rate (GFR) > 50 mL/min
New York Heart Association (NYHA) congestive heart failure (CHF) class II or better
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
Human immunodeficiency virus (HIV) infection without history of acquired immune deficiency syndrome (AIDS) and sufficiently high cluster of differentiation (CD)4 cells (> 400/mm\^3) and low HIV viral loads (< 30,000 copies/ml plasma) not requiring anti-HIV therapy are eligible
Patients must have recovered from the toxicity of prior therapy to less than grade 2

You may not qualify if…

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
Patients with history of allergic reactions attributed to compounds of similar chemical or biologic composition to decitabine that are not easily managed
Major surgery within 2 weeks before day 1
Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose
Known active hepatitis A, B, or C infection; or known to be positive for hepatitis C virus (HCV) ribonucleic acid (RNA) or HBsAg (hepatitis B virus [HBV] surface antigen)
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-human chorionic gonadotropin (beta-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 are excluded
Patients with renal failure (GFR < 50 mL/min) are excluded
Patients that in the opinion of the investigators are significantly below their ideal body weight

Where it is running

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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