Lenalidomide, Cytarabine, and Idarubicin in Treating Patients With Acute Myeloid Leukemia

Inclusion Criteria:

• Cohort 1: Patients must be age >18 and < 65 with relapsed or refractory AML or high risk myelodysplastic syndrome (MDS); high risk MDS is defined as international prognosis scoring system (IPSS) score of 1.5 or higher; eligible patients will have a score of 1.5 or higher at any time from diagnosis to screening

  • Cohort 2: Patients must be age > 18 with previously untreated AML; favorable risk AML patients < 60 years of age are excluded; these are defined as core binding factor (CBF) AML patients and characterized by cytogenetic or molecular evidence of CBF leukemia; untreated AML patients < 60 years of age must be negative on screening for CBF leukemia by cytogenetic or molecular analysis (Note: Prior therapy for MDS is permitted)
• Patients with secondary AML or therapy-related AML are eligible
• No granulocytic sarcoma as the sole site of disease
• No advanced malignant solid tumors or additional active hematologic malignancies
• No active central nervous system (CNS) disease
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Total bilirubin < 2.0 mg/dL
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 2.5 times upper limit of normal
• Creatinine < 2.0 mg/dL AND creatinine clearance > 50 mL/min
• Left ventricular ejection fraction (LVEF) ≥ 40%
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective double-method contraception (one highly effective method and one additional effective method) for ≥ 28 days before, during, and for ≥ 28 days after completion of study treatment

• Patients with active infection are eligible provided the infection is under control

  • Patients with uncontrolled infection may be enrolled after the infection is treated and brought under control
• Patients with a comorbid medical illness are eligible provided their life expectancy attributed to the illness is > 6 months
• No comorbidities that would preclude safety evaluation of study treatment

• No uncontrolled concurrent illness including, but not limited to, any of the following:

  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Serious cardiac arrhythmia
  • Psychiatric illness or social situations that would limit compliance with study requirements
  • Myocardial infarction within the past 6 months
  • NYHA class III-IV heart failure
  • Severe uncontrolled ventricular arrhythmias
  • Electrocardiographic evidence of acute ischemia or active conduction system abnormalities
• No serious medical or psychiatric illness that would interfere with study participation
• No known HIV positivity
• No history of medically serious allergic reactions or non-hematologic toxicities attributed to the agents in this study such as lenalidomide or thalidomide or compounds of similar chemical or biologic composition that are not easily managed, or patients with a history of cerebellar toxicity to cytarabine
• No history of neurologic toxicity with cytarabine
• Prior lenalidomide, cytarabine, and/or idarubicin allowed provided that the combination of the 3 agents has never before been administered and that no lenalidomide has been administered for ≥ 6 months
• Recovered from the adverse events due to agents administered > 4 weeks ago
• More than 2 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) or radiotherapy
• At least 14 days since prior and no other concurrent investigational agents
• No concurrent palliative radiotherapy
• No other concurrent commercial agents or therapies administered with the intent to treat the patient's leukemia