Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia
Condition: Adult Acute Basophilic Leukemia; Adult Acute Eosinophilic Leukemia; Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Secondary Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Leukemia, Monocytic, Acute; Leukemia, Myelomonocytic, Acute; Leukemia, Megakaryoblastic, Acute; Leukemia, Erythroblastic, Acute; Leukemia, Basophilic, Acute; Leukemia, Eosinophilic, Acute; Hypereosinophilic Syndrome
Intervention: lenalidomide
Intervention description: Given orally
Intervention MeSH terms: Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well lenalidomide works in treating older patients with
      acute myeloid leukemia with abnormal chromosome 5q. Biological therapies, such as
      lenalidomide, may stimulate the immune system in different ways and stop cancer cells from
      growing.
    

Eligibility criteria:

        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