Cutaneous T-cell Lymphoma (CTCL)
Conditions
Keywords
CTCL
Brief summary
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).
Detailed description
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.
Interventions
DRUGSapacitabine
Sapacitabine
Sponsors
Cyclacel Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| response rate in overall skin disease | over the course of study | Decrease of lesion from baseline |
Countries
United States
Outcome results
None listed