Efficacy and safety of Targretin capsule 75-mg alone or in combination with phototherapy in Japanese patients with Cutaneous T-cell Lymphomas
- Conditions
- Cutaneous T-Cell Lymphomas
- Registration Number
- JPRN-UMIN000029537
- Lead Sponsor
- agoya City University Graduate School of Medical Sciences Department of Geriatric and Environmental Dermatology
- Brief Summary
We conducted the comparative study on the efficacy and safety between the Targretin monotherapy and the Targretin/phototherapy combination therapy for CTCL. In the efficacy, no difference was observed in the therapeutic effect of the two therapies evaluated by mSWAT and PGA at 8 weeks, but the two therapies have been shown to have therapeutic effects. In the combination therapy, 4 subjects were diagnosed to be the complete response, and it was suggested that the combination therapy may have a high effect.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 53
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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