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:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-26 @ 11:08 AM
NCT ID:
NCT04188912
Eligibility Criteria:
Inclusion Criteria:
* Adults age 18 or older
* Scheduled for allogeneic HCT from any donor for any indication, with a risk of cGVHD of \> 25% (see below in exclusion criteria for treatment plans with a cGVHD risk \< 25%)
* Ability and willingness to comply with the intensive assessment schedule including evaluation every other month at a participating site
* Ability to communicate in English or Spanish, to allow completion of patient surveys and clear communication with the study team
Exclusion Criteria:
* Receipt of umbilical cord blood, bone marrow with post-transplant cyclophosphamide (peripheral blood with post-transplant cyclophosphamide is allowed), anti-thymocyte globulin, alemtuzumab, or ex-vivo T-cell depletion. These patients are excluded because they have a cGVHD risk of \< 25%
* Hematologic malignancy with active disease at the time of transplant. Minimal residual disease is allowed
* Hematopoietic cell transplant co-morbidity index \> 4 based on parameters known at time of enrollment
* Prior allogeneic transplant
* Prior autoimmune disease with ongoing symptoms
* History of noncompliance
* Inability to comply with study requirements due to geographic, logistic, social or any other factors
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04188912
Study Brief:
Protocol Section:
NCT04188912