Lenalidomide in Older Patients With Acute Myeloid Leukemia Without Chromosome 5q Abnormalities
Condition: Leukemia, Myeloid, Acute
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Lenalidomide
Intervention MeSH terms: Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No

Summary:

      This study is designed to test the safety and efficacy of lenalidomide in older patients (age
      > 60 years) with untreated acute myeloid leukemia without chromosomal abnormalities involving
      5q.
    

Eligibility criteria:

        Inclusion Criteria:

          -  AML, de novo, secondary to prior therapy, or transformed from MDS, as defined by the
             International Working Group (except acute promyelocytic leukemia (AML M3). Patients
             must not have abnormalities of chromosome 5q as assessed by routine cytogenetics or
             FISH. Diagnosis of AML by WHO criteria (≥20% blasts) is determined by CBC, bone marrow
             assessment, and immunophenotypic analysis performed within 2 weeks of study
             enrollment.

          -  Intermediate or poor-risk cytogenetics as defined by SWOG criteria

          -  Age ≥ 60 years at the time of signing the informed consent form.

          -  Understand and voluntarily sign an informed consent form.

          -  Able to adhere to the study visit schedule and other protocol requirements.

          -  No previous treatment for AML, however hydroxyurea, steroids, and leukopheresis are
             allowed

          -  ECOG performance status of ≤ 2 at study entry.

          -  Life expectancy > 2 months

          -  Adequate organ function as defined by:

          -  Serum creatinine ≤ 1.5X institution upper limit of normal (ULN)

          -  Total bilirubin ≤ 2.0 mg/dL

          -  AST (SGOT) and ALT (SGPT) ≤ 5 x ULN

          -  Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy
             test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again
             within 24 hours of starting lenalidomide and must either commit to continued
             abstinence from heterosexual intercourse or begin TWO acceptable methods of birth
             control, one highly effective method and one additional effective method AT THE SAME
             TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to
             ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact
             with a FCBP even if they have had a successful vasectomy. All patients must be
             counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal
             exposure.

          -  Disease free of prior malignancies for ≥ 5 years with exception of currently treated
             basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix
             or breast.

        Exclusion Criteria:

          -  Received prior treatment for AML

          -  Favorable risk cytogenetic abnormalities as defined by SWOG criteria
             (http://www.bloodjournal.org/cgi/content/abstract/96/13/4075) that include:
             inv(16)/t(16;16)/del(16q), t(15;17) with/without secondary aberrations, t(8;21)
             lacking del(9q) or complex karyotype (16). Prior to enrollment, FISH, molecular
             studies or routine cytogenetics must be completed to rule out these cytogenetic
             abnormalities.

          -  Known CNS leukemia

          -  Any serious medical condition, laboratory abnormality, or psychiatric illness that
             would prevent the subject from signing the informed consent form.

          -  Any condition, including the presence of laboratory abnormalities, which places the
             subject at unacceptable risk if he/she were to participate in the study or confounds
             the ability to interpret data from the study.

          -  Use of any other experimental drug or therapy within 30 days of enrollment.

          -  Known hypersensitivity to thalidomide.