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 @ 6:43 PM
Ignite Modification Date:
2025-12-24 @ 6:43 PM
NCT ID:
NCT03837457
Eligibility Criteria:
Key Inclusion Criteria:
* Must have participated in the comparator arm of the SOLAR clinical trial and completed the study (confirmed disease progression).
Key Exclusion Criteria:
* Sézary syndrome or mycosis fungoides with B2 involvement, defined as documented history of B2 and/or B2 staging at screening.
* Evidence of large cell transformation.
* Visceral involvement related to MF at screening.
* Unresolved toxicities from prior vorinostat treatment, defined as having not resolved to CTCAE v5.0 grade 0 or 1.
* Any CTCL systemic therapy after completion of the SOLAR study and prior to Day 1 for PRISM.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03837457
Study Brief:
Protocol Section:
NCT03837457