Open-label Pilot Study of Lenalidomide (Revlimid) as Adjuvant Treatment for Refractory Cutaneous T Cell Lymphoma

Patients ≥ 18 years of age (at the time of signing the informed consent).

Able to adhere to the study visit schedule and other protocol requirements.

Histologically confirmed mycosis fungoides or Sezary syndrome

Stage IB to IVB disease at screening (TNMB classification, see Protocol Attachment C)

Refractory disease after at least 2 prior therapies, which may include topicals, phototherapy, bexarotene, interferon, and/or photopheresis. Patients may be currently taking these medication and therapies may be used in combination.

Determined to have adequate baseline organ function defined as:

Hepatic: Total bilirubin ≤ 1.5 x upper limit of normal (ULN),AST and ALT ≤ 3.0 x ULN

Hematologic: Platelets ≥ 75 x 109/L

Absolute neutrophil count (ANC) ≥ 1.0 x 109/L,Hemoglobin ≥ 8.0 mg/dL

Renal: Creatinine clearance ≥ 30 ml/min (Appendix; Cockcroft-Gault formula)

* At least 3 months since the initiation of any new CTCL treatments.

* Stable or progressive disease despite current treatment regimen over the last 3 months.

* All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.

* 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 prior to prescribing lenalidomide (prescriptions must be filled within 7 days) 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.

* 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.

* A female of childbearing potential is a sexually mature woman who:

1. has not undergone a hysterectomy or bilateral oophorectomy

2. has not been naturally postmenopausal for at least 24 consecutive months (has had menses at any time in the preceding 24 consecutive months). See Appendix: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.

* Disease free of prior malignancies for ≥ 5 years, with exception of basal cell and squamous cell carcinoma of the skin, or breast or cervix in situ carcinoma.

* Expected survival of \> 6 months.

* Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation. Patients intolerant to aspirin may use warfarin or low molecular weight heparin.

What this study is about