A Randomized Phase II Study of Oral Sapacitabine in Patients With Advanced Cutaneous T-cell Lymphoma

Inclusion Criteria:

   - Adult patients with advanced CTCL

   - Have had at least 2 systemic therapies

   - Must have evaluable disease

   - Eastern Cooperative Oncology Group performance status 0-2

   - Adequate bone marrow, hepatic and renal function

   - At least 3 weeks from prior therapies

   - Not receiving topical steroids or have been on a stable dose of topical steroids for
   at least 2 weeks

   - Able to swallow capsules

   - At least 3 weeks from major surgery

   - Agree to practice effective contraception

   - Able to understand and willing to sign the informed consent form

Exclusion Criteria:

   - Receiving systemic steroids

   - Receiving topical or systemic retinoids or vitamin A

   - Receiving radiotherapy, biological therapy,or any other investigational agents

   - Uncontrolled intercurrent illness

   - Pregnant or lactating women

   - Known to be HIV-positive

   - Active hepatitis B and/or hepatitis C infection