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 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT03763318
Eligibility Criteria:
Inclusion Criteria:
1. Male or female subject at least 18 years of age for Part A, and at least 12 years of age for Part B.
2. Recipients of allogeneic hematopoietic stem cell transplantation (alloHSCT) using myeloablative or non myeloablative conditioning regimens.
3. Have a clinical diagnosis of acute GVHD requiring systemic immune suppressive therapy.
4. Deemed by the investigator to be likely to comply with the planned procedure as required by the protocol for the duration of the study
Exclusion Criteria:
1. Presence of morphologic relapsed primary malignancy, treatment for relapse after alloHSCT was performed, or requirement for rapid immunosuppressive treatment withdrawal for early malignancy relapse.
2. Evidence of graft failure based on cytopenia(s), and as determined by the investigator.
3. Evidence of post-transplant lymphoproliferative disease.
4. Any prior therapy for acute GVHD, except for alloHSCT prophylaxis regimens or systemically administered corticosteroids.
5. As determined by the investigator, any medical, psychiatric, or other condition or circumstance that is likely to negatively affect: the subject's participation in this clinical study, the subject's safety, or the reliability of the study data.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT03763318
Study Brief:
Protocol Section:
NCT03763318