NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-121825

Registered date:

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedMycosis fungoides or Sezary syndrome
Date of first enrollment01/4/2012
Target sample size15
Countries of recruitment
Study typeINTERVENTIONAL
Intervention(s)Intervention name : S-6810 Dosage And administration of the intervention : Intravenous Control intervention name : null

Outcome(s)

Primary OutcomeEfficacy (response rate)
Secondary OutcomeSafety

Key inclusion & exclusion criteria

Age minimum20
Age maximum
GenderBOTH
Include criteriaMain 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 criteriaMain exclusion criteria: Patients whose visceral metastasis was found by imaging evaluation within 4 weeks prior to enrollment

Related Information

Contact

public contact
Name Shionogi & Co., Ltd. Corporate Communications Department
Address http://www.shionogi.co.jp/information/inquiry_entrance.html
Telephone
E-mail
Affiliation
scientific contact
Name
Address
Telephone
E-mail
Affiliation