Efficacy and safety of bexarotene or bexarotene plus phototherapy in CTC

Phase 4

• Conditions: cutaneous T-cell Lymphoma (CTCL); CTCL; CTC

• Registration Number: JPRN-jRCTs041180094
• Lead Sponsor: Morita Akimichi

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 CR, and it was suggested that the combination therapy may have a high effect.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-13
• Study Completion: 2019-12-24
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 53

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

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

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<br>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<br>Safety: adverse events, hematology, blood chemistry