A Phase II Study of Lenalidomide (REVLIMID, NSC-703831) for Previously Untreated Non-M3, Deletion 5Q Acute Myeloid Leukemia (AML) in Patients Age 60 or Older Who Decline Remission Induction Chemotherapy

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