Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia

Inclusion Criteria:

Morphologically confirmed diagnosis of acute myeloid leukemia (AML) by bone marrow aspiration and biopsy within the past 14 days

Diagnostic biopsy within the past 28 days with marrow blast percentage ≥ 70% allowed provided no potentially antileukemic therapy was received after biopsy
Cytogenetic evidence of del (5q) abnormality by conventional karyotyping or fluorescence in situ hybridization (FISH)

Previously untreated disease

Must have declined standard AML cytotoxic chemotherapy regimens
WBC ≤ 30,000/mm³
History of prior myelodysplastic syndromes (MDS) allowed
No acute promyelocytic leukemia (FAB M3)
No blastic transformation of chronic myelogenous leukemia
Zubrod performance status 0-2
Bilirubin ≤ 2.5 times upper limit of normal (ULN) (unless elevation is due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert's syndrome or hemolysis, but not to liver dysfunction)
AST and ALT ≤ 3.5 times ULN
Creatinine ≤ 1.5 times ULN
HIV negative
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use 2 forms of effective contraception at least 4 weeks prior to, during, and for 4 weeks after completion of study treatment
No known allergy to thalidomide
Concurrent enrollment on SWOG-S9910 allowed (for SWOG patients)

No prior systemic chemotherapy for acute leukemia except hydroxyurea

Single-dose intrathecal chemotherapy allowed before or concurrently with induction chemotherapy
No prior AML induction-type chemotherapy or high-dose chemotherapy with hematopoietic stem cell support
Prior hematopoietic growth factors, thalidomide, arsenic trioxide, signal-transduction inhibitors, azacitidine, and low-dose cytarabine (i.e., < 100 mg/m²/day) for treatment of MDS allowed
At least 30 days since prior therapy for MDS (excluding growth factors)
No prior lenalidomide for MDS
At least 6 months since prior chemotherapy or radiotherapy for another malignancy
No concurrent therapy for another malignancy
Concurrent hormonal therapy allowed