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:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2025-12-24 @ 1:00 PM
NCT ID:
NCT02213861
Eligibility Criteria:
Inclusion Criteria:
* Histological confirmation of CTCL; a documented verifiable biopsy report is required
* Documented clinical stage IA, IB or IIA CTCL
* Skin lesion involvement of at least 2% of BSA accessible for topical application of study drug
* ECOG performance status of 0-2
Exclusion Criteria:
* CTCL with histologic evidence of folliculotropic variant or large cell transformed CTCL
* Palpable lymph node ≥1.5 cm in diameter (unless the lymph node has been biopsied and designated as Stage IA-IIA disease)
* Co-existent second malignancy or history of prior solid organ malignancy within previous 5 years (excluding basal or squamous cell carcinoma, in situ carcinoma of the cervix (CIN3), papillary or follicular thyroid cancer or prostate cancer that has been treated curatively
* Any prior history of hematologic malignancy (other than CTCL) within past 5 years
* CTCL disease that is known to be refractory to systemic histone deacetylase inhibitors
* Prior or concurrent central nervous system (CNS) metastases
* History of or current major gastrointestinal, pulmonary, cardiovascular, genitourinary or hematologic disease, CNS disorders, infectious disease or coagulation disorders as determined by the Investigator
* Evidence of active Hepatitis B or C or HIV
* Circulating atypical cells of clinical significance
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02213861
Study Brief:
Protocol Section:
NCT02213861