Efficacy and safety of bexarotene or bexarotene plus phototherapy in CTCL

JRCT ID: jRCTs041180094

Registered date:13/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: cutaneous T-cell Lymphoma (CTCL)
• Date of first enrollment: 03/04/2019
• Target sample size: 60
• Study type: Interventional

Intervention(s)

Targretin alone: Patients are p.o. administrated a 300 mg/m2 dose of bexarotene once daily for 8 weeks.
Targretin + phototherapy: Patients are p.o. administrated a 300 mg/m2 dose of bexarotene once daily for 8 weeks.
Patients are treated with psoralen baths preceding treatment with UVA radiation 5 times weekly. The initial dose of UVA was 0.5 J/cm2, dose incrementof 0.5 J/cm2, dose incrementof 0.5 J/cm2 each radiation. The maximum dose was 4.0 J/cm2.
The initial dose of narrowband UVB administered is 50-70% of the MPD or 0.5-0.7 J/cm2. The dose of NB-UVB for the subsequent NB-UVB sessions is elevated 20% increment with each successive treatment session. The maximum dose is 2.0 J/cm2.

Outcome(s)

Primary Outcome

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

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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 UVB 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 within 4 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 artificial UC light while receiving bexarotene
10. Principal investigator or subinvestigator judged inadequate

Related Information

• Primary Sponsor: Morita Akimichi
• Source(s) of Monetary Support: Minophagen Pharmaceutical Co., LTD
• Secondary ID(s): UMIN000029537