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