Cutaneous T-Cell Lymphomas
Conditions
Interventions
Patients are p.o. administrated a 300 mg/m2 dose of bexarotene once daily for 8 weeks.
Patients are p.o. administrated a 300 mg/m2 dose of bexarotene once daily for 8 weeks. Patients are treated with
Sponsors
Nagoya City University Graduate School of Medical Sciences Department of Geriatric and Environmental Dermatology
Osaka City University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must have met all of the following inclusion criteria: 1. A clinical diagnosis of cutaneous T-cell lymphomas confirmed by biopsy to be histologically consistent with CTCL diagnosis by dermatopathologist 2. Age >= 20, written approval of patient
Exclusion criteria
Exclusion criteria: 1. Contraindications (severe liver failure, known hypersensitivity to bexarotene, systemic therapy with vitamin A or oral retinoid therapy at the entry in this study, hypervitaminosis A) 2. Patients with pregnancy, breast-feeding or intent to become pregnant 3. Skin-directed therapies, local chemotherapy, topical steroids, etc. within 2 weeks of study entry. Low- and mid-potency topical corticosteroids were allowed only for subjects using a stable dose regimen at least 2 weeks prior to study entry. High potency topical corticosteroids were not allowed permitted. 4. Prior therapy for the treatment of CTCL: therapy with UVA or UBV within 3 weeks of study entry 5. Prior therapy for the treatment of CTCL: radiotherapy within 4 weeks of study entry 6. Prior therapy for the treatment of CTCL: therapy with bexarotene within4 weeks of study entry 7. Known allergic reaction or hypersensitivity to bexarotene or other component of Targretin capsules 8. History of severe allergic reaction or hypersensitivity to any other drugs or prior therapy for the treatment of CTCL 9. Unwillingness or inability to minimize exposure to sunlight and antificial UV light while receiving bexarotene 10. Principal investigator or subinvestigator judged inadequate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endopoints evaluated though the 8 weeks of treatment were follows: Modified Severity-weighted Assessment Tool (mSWAT), Physician's Global Assessment (PGA) | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: time to cutaneous tumor response, time to cutaneous tumor progression, amount of irradiation and UV dose, amount of bexarotene, capsules, and compliance rate, LDH, sIL-2R, TARC, T-cell receptor repertoire analysis Safety: adverse events, hematology, blood chemistry | — |
Countries
Japan
Contacts
Public ContactAkimichi Morita
Nagoya City University Graduate School of Medical Sciences Department of Geriatric and Environmental Dermatology
Outcome results
None listed