Lenalidomide in Acute Leukemias and Chronic Lymphocytic Leukemia.

Rationale:

Lenalidomide has properties of thalidomide and appears to have some activity against cancer
in laboratory tests. Researchers are still learning how lenalidomide works against cancer in
patients. Some ways that this drug seems to produce anti-cancer effects include through
stimulating the immune system and blocking blood vessels contributing to cancer growth. The
current study will explore different dose levels in patients to gather more information about
lenalidomide.

Purpose:

This study will assess the maximum tolerated dose of lenalidomide in patients with relapsed
or refractory acute leukemias and chronic lymphocytic leukemias. Toxicity or side effects
within patients will also be evaluated. Other purposes of this study include analyzing
preliminary clinical activity, pharmacokinetics, and pharmacodynamics. Pharmacokinetics
refers to the activity of drugs in the body over a period of time, including how drugs are
absorbed, distributed, localized in tissues, and excreted. Pharmacodynamics refers to the
bodily processes that lead the drug to effect cancer and other cellular components in the
body.

Treatment:

Study participants will be given lenalidomide through intravenous infusions once every 28
days. A 28-day period constitutes a cycle. Since this study will assess the maximum tolerated
dose of lenalidomide, some study participants will receive different amounts of this drug
compared to others depending upon when each individual enrolls in the study. Each group of 3
to 6 study participants will receive a higher dose of lenalidomide until the maximum
tolerated dose is established. Several tests will be performed throughout the study,
including bone marrow biopsies. Imaging exams will be conducted as well. Treatments will be
discontinued due to disease growth or intolerable adverse effects. Lenalidomide
administration will be repeated for 12 or more cycles in patients that experience clinical
benefit.

Inclusion Criteria:

- Blood blast count must be < 40,000/uL prior to initiation of therapy. Hydroxyurea (up
to 6g/day) may be administered prior to initiation of therapy and during the first
week to maintain blood blast count < 40,000/uL

- ECOG(Eastern Cooperative Oncology Group)performance status 0-2.

- Patients with CNS(central nervous system)involvement will be considered eligible for
this study if no residual leukemic cells are detected in the CSF (cerebrospinal
fluid)following intrathecal chemotherapy or radiation.

Exclusion Criteria:

- Patients with acute promyelocytic leukemia are excluded unless patient has failed
salvage therapy with arsenic.

- Patients with HIV are excluded due to increased risk of infectious complications,
marrow suppression, and potential interactions with antiviral therapy.

- CLL patients who have had chemotherapy (with the exception of hydroxyurea) or
radiotherapy within 4 weeks prior to entering the study are excluded. CLL patients
receiving corticosteroids (within 2 weeks) for treatment of disease (other than
autoimmune manifestations of CLL) are not eligible.

- Patients who have received mitomycin C or nitrosourea require a six weeks recovery
period before they can be enrolled on the current study.

- Patients with the following abnormal clinical values are excluded (unless
abnormalities in these parameters are directly attributable to malignancy): Serum
creatinine >2.0 mg/dl Total bilirubin > 2 x upper limit of normal (unless due to
Gilbert's syndrome) ALT and AST > 5 x upper limit of normal