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 @ 3:15 PM
Ignite Modification Date:
2025-12-24 @ 3:15 PM
NCT ID:
NCT05515692
Eligibility Criteria:
Inclusion Criteria:
* Documented informed consent of the participant and/or legally authorized representative
* Agreement to allow the use of archival tissue from diagnostic tumor biopsies
* If unavailable, exceptions may be granted with study principal investigator (PI) approval
* Permitting to perform clinical photography
* Age: \>= 18 years
* Histologically confirmed sclerodermatous GHVD
* Relapsed/refractory sclerodermatous cGVHD
* Measurable disease of at least 2.0 cm
* Failed at least \>= 2 prior frontline therapies for sclerodermatous chronic GvHD
* Fully recovered from the acute toxic effects (except alopecia) to =\< Grade 1 to prior therapy
* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
* To be performed within 7 days prior to Day 1 of protocol therapy unless otherwise stated
* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 1 month after the last dose of protocol therapy
* Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
Exclusion Criteria:
* Chemotherapy, radiation therapy, biological therapy, immunotherapy within 21 days prior to Day 1 of protocol therapy
* Herbal medications
* Females only: Pregnant or breastfeeding
* Inability to comprehend and sign inform consent
* Individuals known to carry germline gene mutations in TP53, NBS and ATM.
* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05515692
Study Brief:
Protocol Section:
NCT05515692