PUVA Maintenance Therapy in Mycosis Fungoides

• Status: Completed
• Trial end date: 2018-07-02
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine whether psoralen plus UVA (PUVA) photochemotherapy maintenance treatment prolongs disease-free survival of cutaneous T cell lymphoma (mycosis fungoides) patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Graz
• Treatments: Methoxsalen

Criteria

Inclusion Criteria:

• Histopathologically documented MF clinical stage IA-IIB (see Table1) confirmed by current or previous diagnostic lesion biopsy

• A Karnofsky performance score > 60

• No previous PUVA treatment

• Anti-ds-DNA (antinuclear antibodies) or anti-Ro/La antibodies: negative

• Acceptable organ function defined as follows:

SGOT (AST) and SGPT (ALT) < 2.5 times the upper limit of normal for the institution

• Creatinine < 2 times the upper limit of normal for the institution

• No evidence of severe cardiac insufficiency (NYHA grade III-IV)

• Women of child bearing potential must have a negative serum pregnancy test (ß-HCG) within seven (7) days prior to randomization

• Absence of any serious intercurrent illness or infection at time of entry into the study that could interfere with planned treatment

• Patients must be willing to accept limiting sun exposure on the day receiving PUVA treatment

• Written informed consent

Exclusion Criteria:

• Pregnancy and Lactation

• Photosensitive diseases such as lupus erythematosus or basal cell nevus syndrome

• Skin cancer syndromes such as xeroderma pigmentosum or basal cell nevus syndrome