Ibrutinib, Idarubicin and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Exclusion Criteria

• •Received anticancer therapy (chemotherapy, immunotherapy, radiotherapy, or investigational therapy) within 2 weeks prior to starting study treatment \[EXCEPTION: Hydroxyurea (hydrea) to control high white blood cell count is permitted\]
• •Receiving any other investigational agents within 14 days or 5 effective half lives (whichever is shorter) prior to 1st dose of ibrutinib
• •Prior treatment with ibrutinib
• •Known acute promyelocytic leukemia (French-American-British Class M3-AML)
• •Known active central nervous system (CNS) leukemia
• •Prior bone marrow transplant presenting with active uncontrolled graft vs host disease (GvHD)
• •Known congenital bleeding disorders, such as hemophilia
• •Known history of stroke or intracranial hemorrhage within 6 months prior to study treatment
• •Concomitant use of warfarin or other vitamin K antagonists
• •Requires treatment with strong CYP3A inhibitors at the time of study enrollment. Washout period is 5 effective half-lives is required prior to 1st dose of ibrutinib
• •Requires treatment with strong CYP3A inducers at the time of study enrollment. Washout period is 5 effective half-lives is required prior to 1st dose of ibrutinib
• •Known active uncontrolled systemic infection
• •Major surgery within 4 weeks of 1st dose of ibrutinib
• •Unable to swallow capsules
• •Known Malabsorption syndrome
• •Known Disease significantly affecting gastrointestinal function
• •Resection of the stomach or small bowel
• •Uncontrolled symptomatic inflammatory bowel disease
• •Ulcerative colitis
• •Bowel obstruction, partial or complete
• •Congestive heart failure with ejection fraction (EF) \< 45%
• •Uncontrolled cardiac disease, including uncontrolled cardiac arrhythmia or coronary artery disease (CAD) with active symptoms due to CAD defined as unstable angina
• •History of allergic reactions attributed to compounds of similar chemical or biologic composition to ibrutinib; idarubicin; or cytarabine
• •Uncontrolled intercurrent illness including, but not limited to:
• •Active infection
• •Psychiatric illness/social situations that would limit compliance with study requirements
• •Pregnant
• •Lactating
• •Known positive HIV
• •Known active hepatitis C
• •Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)