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 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT03689894
Eligibility Criteria:
Inclusion Criteria:
1. Men and women ≥18 years old who are recipients of an allogeneic bone marrow, cord blood or peripheral blood stem cell transplant. (There will be no restrictions based upon underlying disease, donor source, degree of human leukocyte antigen (HLA) match, intensity of pre-transplant conditioning regimen or use of prior donor lymphocyte infusion(s).)
2. Chronic GVHD that is confirmed by clinical assessment and/or biopsy.
3. Either steroid-refractory or steroid-dependent cGVHD.
4. Karnofsky performance status ≥ 60.
Exclusion Criteria:
1. History of treatment with a tyrosine kinase inhibitor (eg, imatinib) or other moderate-to-significant Cyclophilin A4 inhibitor within 2 weeks of enrollment.
2. Renal insufficiency as follows: creatinine \> 2.5 mg/deciliters (dL) or Creatinine Clearance \< 30 ml/min.
3. Hepatic insufficiency as follows: serum bilirubin \>3 mg/dL or transaminitis \>3x upper limit of normal (ULN) (unless deemed due to GVHD).
4. History of cardiac dysrhythmias or known cardiovascular disease without formal Cardiology clearance.
5. History of cerebro-vascular accident or intracranial hemorrhage within 6 months prior to enrollment.
6. History of non-intracranial hemorrhage and/or coagulopathy without formal Coagulation clearance.
7. Uncontrolled infections not responsive to antibiotics, anti-viral medicines, or anti-fungal medicines; or infection requiring systemic treatment that was completed ≤14 days before enrollment.
8. History of other hematologic malignancy.
9. History of human immunodeficiency virus (HIV).
10. History of active hepatitis B virus (HBV) or hepatitis C virus (HCV) without formal Infectious Disease clearance.
11. Patients incapable of complying with routine follow up schedule or unable to be compliant with study therapy.
12. Active or within 3 months use of prohibited medications or substances (e.g., illicit drugs).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03689894
Study Brief:
Protocol Section:
NCT03689894