Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 1:03 AM
NCT ID:
NCT00099593
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed diagnosis of Sezary syndrome
* Must be willing to discontinue concomitant medications for CTCL, including: \*Oral steroids above 10 mg - 30 day washout, unless subject has Addison's Disease or adrenal insufficiency, \*PUVA or UVB - 2 week washout, sunbathing, tanning beds, etc. and for the duration of the study, \*Electron Beam - for the duration of the study, \*Chemotherapeutic agents - 30 day washout, \*Bexarotene capsules or other oral biologics - 3 week washout, \*Topical nitrogen mustard - 2 week washout, \*Extracorporeal photopheresis - 4 week washout and for the duration of the study.
* Must be at least 18 years of age and must be able to understand the written informed consent.
* Subjects must have no evidence of active infection. Subjects with active infections (whether or not they require antibiotic therapy) may be eligible for continuation of therapy after complete resolution of the infection. Subjects on antibiotic therapy must be off antibiotics for at least 7 days before beginning treatment.
Exclusion Criteria:
* Subjects with autoimmune disease, HIV, and/or hepatitis
* Subjects who are pregnant or lactating
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00099593
Study Brief:
Protocol Section:
NCT00099593