Clinical trial NCT02255162 (phase 1, status: terminated)
Conditions: acute myeloid leukemia (aml), acute myelocytic leukemia, acute myelogenous leukemia, acute granulocytic leukemia, acute non-lymphocytic leukemia
ICD codes: 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
Drugs: lenalidomide, cytarabine
SMILES: NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O, ClCCN(CCCl)P1(=O)NCCCO1
Reason stopped: 
    slow accrual
  
Eligibility criteria:

        Inclusion Criteria:

          -  Recipient Inclusion Criteria

          -  Adults, aged 18 through 75 years of age, with pathologically confirmed acute
             myelogenous leukemia, in pathologically confirmed complete remission following
             anti-leukemic therapy.

          -  AST, ALT and Alkaline Phosphatase <5x Upper Limit normal (ULN), direct bilirubin < 2.0
             mg/dl.

          -  Adequate renal function as defined by: calculated creatinine clearance ≥ 60 mL/min
             (Cockcroft-Gault Formula) or serum Cr less than institution ULN (the elderly will
             often have < 60 GFR)

          -  ECOG performance status 0-2.

          -  Have a diagnosis of high-risk AML as established by a poor-risk karyotype, adverse
             risk by ELN criteria, a therapy-related AML, age ≥ 60 or with antecedent hematologic
             disorder

          -  LVEF must be equal to or greater than 40%, as measured by MUGA scan or echocardiogram

          -  Patients, or appropriate designee, must be able to provide informed consent.

          -  Must not have received systemic anti-neoplastic therapy, including radiotherapy within
             14 days of study treatment.

          -  Female patients of childbearing age must have negative pregnancy test.

          -  Male subject agrees to use an acceptable method for contraception during the entire
             study treatment period and through 6 months after the last dose of lenalidomide.

          -  All study participants must be registered into the mandatory Revlimid REMS® program,
             and be willing and able to comply with the requirements of the REMS® program.

          -  Females of reproductive potential must adhere to the scheduled pregnancy testing as
             required in the Revlimid REMS® program. If needed, patients should be able to take
             aspirin (81 or 325 mg) daily as prophylactic anticoagulation.

          -  Donor Inclusion Criteria

          -  Haploidentical 1st-degree relative as defined by 3/6 or 4/6 HLA-matched at HLA -A, -B,
             or -DRB1 who is 18-70 years of age

          -  ECOG performance status 0 or 1

          -  Excellent health per conventional pre-donor history (medical and psychosocial
             evaluation)

          -  No positive testing for viral infection (HbsAg, HIV, HCV)

          -  Donor ability to understand and provide informed consent

          -  Meets standard institutional criteria for GCSF mobilized PBSC donation

        Exclusion Criteria:

          -  Recipient Exclusion Criteria

          -  Diagnosis of acute promyelocytic leukemia

          -  Active refractory or relapsed acute leukemia

          -  Prior use of fludarabine, as this agent has been associated with higher subsequent
             rates of graft versus host disease

          -  Individuals with a history of a different malignancy are ineligible except for the
             following circumstances. Individuals with a history of other malignancies are eligible
             if they have been disease-free for at least 3 years and are deemed by the investigator
             to be at low risk for recurrence of that malignancy. Individuals with the following
             cancers are eligible if diagnosed and treated within the past 3 years: cervical cancer
             in situ, and basal cell or squamous cell carcinoma of the skin.

          -  Uncontrolled intercurrent illness that would limit compliance with study requirements.

          -  HIV-positive individuals on combination antiretroviral therapy are ineligible because
             of the potential for pharmacokinetic interactions with study drug. In addition, these
             individuals are at increased risk of lethal infections when treated with
             marrow-suppressive therapy.

          -  A diagnosis of active hepatitis B or C as defined by detectable viral load assays in
             the blood

          -  Known hypersensitivity to thalidomide or lenalidomide.

          -  The development of erythema nodosum if characterized by a desquamating rash while
             taking lenalidomide.

          -  Significant cardiac disease as determined by the investigator including:

               -  Known or suspected cardiac amyloidosis

               -  Congestive heart failure of Class III or IV of the NYHA classification

               -  Uncontrolled angina, hypertension or arrhythmia

               -  Myocardial infarction in past 6 months

               -  Any uncontrolled or severe cardiovascular disease

               -  Prior cerebrovascular event with persistent neurologic deficit

          -  Medical conditions that, in the investigator's opinion, would impose excessive risk to
             the subject.

          -  Equal to or greater than grade 2 ataxia, cranial or peripheral neuropathy.

          -  Systemic infection requiring IV antibiotic therapy within 7 days preceding the first
             dose of study drug, or other severe infection.

          -  Pregnant women are excluded from this study.