Cutaneous T-cell Lymphoma, Mycosis Fungoides, Sezary Syndrome
Conditions
Keywords
CTCL
Brief summary
A study for patients diagnosed with advanced cutaneous T-cell lymphoma (stage 1B or higher) who have progressive, persistent, or recurrent disease on or following 2 other therapies, one of which must have contained Targretin (bexarotene)or for patients who are not candidates or could not tolerate Targretin therapy.
Interventions
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with Cutaneous T-cell Lymphoma (Stage 1B or higher) * Age: over 18 years of age * Have the ability to swallow capsules. * You must be at least 3 weeks from any prior chemotherapy or anticancer therapy treatment and have recovered from any side effects of that treatment. * Patients also require adequate heart, liver, and kidney function.
Exclusion criteria
* Pregnant and nursing women and those with known allergy to the study drug are excluded from this study. * Patients are excluded if they are currently receiving chemotherapy, radiation therapy, or other investigational anti-cancer therapy. * Patients diagnosed with HIV, active hepatitis or who require intravenous antibiotics or antifungal agents are not permitted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate in patients with progressive, persistent, or recurrent disease. | — |
Secondary
| Measure | Time frame |
|---|---|
| Response duration, relief of pruritis, time to progression, time to objective response, safety & tolerability in this population. | — |
Outcome results
None listed