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

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

This is an open label, randomized phase II study designed to evaluate the tolerability and response rate of high-dose and low-dose regimens in patients with advanced cutaneous T-cell lymphoma (CTCL).

This is an open label, randomized phase II study designed to evaluate the tolerability and response rate of high-dose and low-dose regimens in patients with advanced cutaneous T-cell lymphoma (CTCL) who have had progressive, recurrent, or persistent disease on or following 2 systemic therapies.

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