Phase I Study of Lenalidomide in Acute Leukemias and Chronic Lymphocytic Leukemia.
- 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 performance status 0-2.
- Patients with CNS involvement will be considered eligible for this study if no
residual leukemic cells are detected in the CSF following intrathecal chemotherapy or
- 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