Lenalidomide in Treating Patients With High Risk Acute Myeloid Leukemia in Remission
Condition: Alkylating Agent-Related Acute Myeloid Leukemia; Secondary Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Laboratory Biomarker Analysis; Lenalidomide
Intervention description: Correlative studies; Given PO
Intervention MeSH terms: Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well lenalidomide works in treating patients with acute
      myeloid leukemia that have had a decrease in or disappearance of signs and symptoms of
      cancer, although cancer still may be in the body and may be likely to come back or spread.
      Biological therapies, such as lenalidomide, use substances made from living organisms that
      may kill cancer cells by blocking blood flow to the cancer and by stimulating white blood
      cells to kill the cancer cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients aged 18 to 55 years with high risk AML who have achieved their FIRST complete
             remission (CR) or complete remission with incomplete recovery (CRi) within 12 months
             of enrollment and are not immediately candidates for allogeneic stem cell transplant;
             patients above age 55 who are not eligible for other protocols may be considered for
             enrollment on a case by case basis after discussion with the principal investigator
             (PI)

          -  Patients in their FIRST CR or CRi may be eligible for enrollment only if they have a
             high risk feature, including, but not limited to: adverse karyotype, fms-related
             tyrosine kinase 3 (FLT3) mutation, history of antecedent hematologic disorder (AHD),
             presence of dysplasia in the bone marrow, therapy-related AML, history of requiring
             more than 1 cycle of intensive induction chemotherapy to achieve first remission, or
             presence of persistent minimal residual disease (detected by cytogenetics, molecular
             markers, or flow cytometry) at any point after initial induction cycle; patients aged
             >= 18 years with AML who have achieved a SECOND CR or CRi within 12 months of
             enrollment and are not immediately candidates for allogeneic stem cell transplant are
             also eligible

          -  Patients should have received induction chemotherapy for AML and at least 1
             consolidation

          -  Patients with history of extramedullary AML, except for central nervous system (CNS)
             involvement that is currently controlled, will not be eligible for enrollment

          -  Eastern Cooperative Oncology Group (ECOG) performance status of < or = 3

          -  Serum total bilirubin < or = to 1.5 X the upper limit of normal (ULN)

          -  Serum creatinine < or = to 2.5 x ULN

          -  Absolute neutrophil count (ANC) > 0.5 x 10^9/L

          -  Platelet count > or = 30 x 10^9/L

          -  For females of childbearing age, they may participate it they: a. have a negative
             serum or urine pregnancy test within 10 to 14 days of enrolling (a second pregnancy
             test will be performed within 24 hours (hrs) of starting therapy and both negative
             pregnancy tests will be required for starting therapy); b. agree to either abstinence
             or 2 effective contraceptive methods throughout the treatment period and up to 28 days
             after discontinuing treatment

          -  For male patients with a female partner of childbearing age, they may participate if
             they agree to either abstinence or 2 effective contraceptive methods throughout the
             treatment period and up to 28 days after discontinuing treatment

          -  All study participants be willing and able to comply with the requirements of the Risk
             Evaluation and Mitigation Strategies (REMS) program

          -  Females of reproductive potential must adhere to the scheduled pregnancy testing as
             required in the Revlimid REMS program

          -  Ability to understand and sign informed consent

        Exclusion Criteria:

          -  Diagnosis of acute promyelocytic leukemia (APL), AML - M3 by French American British
             (FAB) classification based on morphology, immunophenotype, molecular, or cytogenetics
             studies

          -  Diagnosis of AML associated with the following karyotypes: inversion (inv)(16),
             t(16;16), t(8;21), t(15;17), or t(9;22)

          -  Uncontrolled intercurrent illness including, but not limited to ongoing or active
             uncontrolled infection, symptomatic congestive heart failure, unstable angina
             pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would
             limit compliance with study requirements

          -  Previous treatment with lenalidomide for AML

          -  Patients with documented hypersensitivity to any components of the study program

          -  Females who are pregnant

          -  Patients with active CNS disease