Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia Who Have Undergone Stem Cell Transplant

PRIMARY OBJECTIVES:

I. To determine the safety and efficacy of maintenance lenalidomide post autologous
peripheral blood stem cell transplantation (PBSCT) for elderly patients with acute myeloid
leukemia (AML).

SECONDARY OBJECTIVES:

I. To define maximum tolerated dose (MTD) and establish therapeutic dose level (TDL) of
lenalidomide given post autologous transplant for AML.

II. To determine the progression free survival for patients treated with this approach.

III. To determine the overall survival for patients treated with this approach. IV. To
determine the role of residual AML stem cells on efficacy of lenalidomide maintenance after
autologous PBSCT.

OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.

Patients receive lenalidomide orally (PO) once daily (QD) on days 1-21. Courses repeat 4
weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then every 6
months thereafter.

Inclusion Criteria:

- Patients must have a confirmed diagnosis of non-M3 AML; antecedent myelodysplastic
syndrome (MDS) is acceptable

- Post autologous stem cell transplant bone marrow biopsy core that is consistent with
morphologic remission

- Must have received induction and consolidation chemotherapy, and autologous stem cell
transplant for AML

- Life expectancy of greater than 12 months

- Karnofsky performance status 70 or greater

- Leukocytes >= 2,000/mcL

- Absolute neutrophil count >= 1,000/mcL

- Platelets >= 75,000/mcL

- Total bilirubin =< 4 X institutional upper limit of normal unless 2nd to Gilbert's
disease

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and
alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 4 X
institutional upper limit of normal

- Creatinine < 1.5 X institutional upper limit of normal OR creatinine clearance >= 30
mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

- Able to take aspirin, or warfarin, or low molecular weight heparin as prophylactic
anticoagulation

- Ability to understand and the willingness to sign a written informed consent document

- Must be registered into the mandatory RevAssist® program and be willing and able to
comply with the requirement of RevAssist®

Exclusion Criteria:

- Patient received chemotherapy or radiotherapy within 2 weeks prior to entering the
study or has not recovered from adverse events due to agents administered more than 4
weeks earlier

- Patient received another investigational agent after post autologous stem cell
transplant

- Patient who will be receiving another investigational product during the study

- Patient who is growth factor or transfusion dependent

- Patient has central nervous system (CNS) leukemia

- History of allergic reactions attributed to thalidomide or lenalidomide

- History of erythema nodosum, characterized by a desquamating rash while taking
thalidomide or similar drugs

- Prior malignancies except resected basal cell carcinoma or treated cervical carcinoma
in situ; cancer treated with curative intent < 5 years

- Uncontrolled illness including, but not limited to ongoing or active infection,
unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social
situations that would limit compliance with study requirements; patients must not
have suffered recent (< 6 months) myocardial infarction, unstable angina,
uncontrolled hypertension, or difficult to control cardiac arrhythmias

- Evidence of uncontrolled congestive heart failure (CHF)

- Active hepatitis B as defined by hepatitis B surface antigen positivity, unless able
to start dual anti-hepatitis B (HepB) therapy, or already on dual anti-HepB therapy

- Patients who are positive for hepatitis B core antibody, but negative for the
hepatitis B surface antigen, should be on lamivudine 100 mg daily until at least 3
months post-transplant

- Patient is positive for human immunodeficiency virus (HIV) or human T-cell
lymphotropic virus (HTLV)-1

- Women of childbearing potential (defined as a sexually mature woman who has not
undergone a hysterectomy or who has had menses at any time in the preceding 24
consecutive months)

- Men who did not agree not to father a child and who refused to use a latex condom
during any sexual contact with women of childbearing potential while taking
lenalidomide and for 4 weeks after therapy is stopped, even if they have undergone a
successful vasectomy