| Inclusion Criteria: | 1) Patients with histological confirmation of mycosis fungoides and Sézary Syndrome (pathology report must read diagnostic or consistent with MF/SS). Stage of disease at study entry may include stage IA to stage IVB according to TNMB classification.
2) Patients must have failed at least one prior topical treatment including steroids, nitrogen mustard, retinoids, phototherapy, photochemotherapy, radiation, and total skin electron beam.
3) Patients must have an ECOG/WHO performance status of </= 2.
4) Patients must have measurable disease, and one or more indicator lesions must be designated prior to study entry (Composite Assessment (CA) of Index Lesion Severity). Erythrodermic patients will also qualify and be assessed by criteria outlined in section 13.0.
5) Age >/= 18 years.
6) Patients must be free of acute infection requiring systemic treatment.
7) Patients must have preserved organ function including a serum creatinine </= 2.0 mg/dL total serum bilirubin </= 2.2 mg/dL serum AST (SGOT) and ALT (SGPT) </= 2 x ULN, leukocyte count >/= 3,000/mm^3 with absolute neutrophil count >/= 1,500/mm^3, and platelet count >/= 100,000/mm^3
8) Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 – 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide (continues in eligibility #9)
9) FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex* condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
10) Patients must be disease free of prior malignancies for >/= 5 years with exception of currently treated squamous cell and basal cell carcinoma of the skin, carcinoma in situ of the cervix, or surgically removed melanoma in situ of the skin (Stage 0), with histological confirmed free margins of excision.
11) Patients must give written informed consent prior to registration on study.
12) No serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
13) No condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
14) No prior use of lenalidomide.
15) No concurrent use of other anti-cancer agents or treatments.
16) Not known to be positive for HIV or infectious hepatitis, type A, B or C. |