Efficacy and safety of bexarotene combined with phototherapy in Japanese patients with Cutaneous T-cell Lymphomas

Efficacy and safety of bexarotene combined with phototherapy in Japanese patients with Cutaneous T-cell Lymphomas - Efficacy and safety of bexarotene combined with phototherapy in Japanese patients with Cutaneous T-cell Lymphomas

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000024532

Enrollment

Registered

2016-10-24

Start date

2016-10-24

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous T-Cell Lymphomas

Interventions

Patients are p.o. administrated a 300 mg/m2 dose of bexarotene once daily for 24 weeks. Patients are treated with psoralen baths preceding treatment with UVA radiation 5 times weekly. The initial do

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. Principal investigator or subinvestigator judged inadequate

Design outcomes

Primary

Measure	Time frame
Modified Severity-weighted Assessment Tool (mSWAT) Physician's Global Assessment (PGA)	—

Secondary

Measure	Time frame
Safety: adverse events, hematology, blood chemistry, computed tomography of the abdomen and pelvis, ophthalmologic slit lamp examinations Efficacy: LDH, sIL-2R, biopsy, response rate, duration of response, amount of irradiation and UV dose	—

Countries

Japan

Contacts

Public ContactAkimichi Morita

Nagoya City University Graduate School of Medical Sciences Department of Geriatric and Environmental Dermatology

amorita@med.nagoya-cu.ac.jp052-853-8261

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026