NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Mycosis fungoides or Sezary syndrome
Date of first enrollment	01/4/2012
Target sample size	15
Countries of recruitment
Study type	INTERVENTIONAL
Intervention(s)	Intervention name : S-6810 Dosage And administration of the intervention : Intravenous Control intervention name : null

Outcome(s)

Primary Outcome	Efficacy (response rate)
Secondary Outcome	Safety

Key inclusion & exclusion criteria

Age minimum	20
Age maximum
Gender	BOTH
Include criteria	Main inclusion criteria 1. Patients with mycosis fungoides or Sezary syndrome confirmed by cutaneous symptom, histopathological diagnosis or hematological evidence 2. Patients whose TNMB staging criterion is T1-4N0-2M0B0-2 and meet any of the following: a) untreated mycosis fungoides/Sezary syndrome b) at least 4 weeks after treatment for mycosis fungoides/Sezary syndrome c) the effect of topical steroid, topical vitamin D3 derivatives, or ultraviolet therapy for mycosis fungoides/Sezary syndrome is stable or progressive within 4 weeks 3. Patients whose ECOG performance status is grade 0-2
Exclude criteria	Main exclusion criteria: Patients whose visceral metastasis was found by imaging evaluation within 4 weeks prior to enrollment