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 @ 9:50 PM
Ignite Modification Date:
2025-12-24 @ 9:50 PM
NCT ID:
NCT04189432
Eligibility Criteria:
Inclusion Criteria:
* Subjects who are males or females aged \>= 19 years, 40kg to 80kg in weight
* Steroid dependent/refractory chronic graft versus host disease (cGVHD) defined as the National Institutes of Health (NIH) criteria (2014) below at any time post-hematopoietic cell transplant (post-HCT):
Refractory disease, defined as, 1) when cGVHD manifestations progress despite the use of a regimen containing glucocorticoid (prednisolone at \>=1 mg/kg/day for at least 2 weeks) or 2), 3) Persist without improvement despite continued treatment with glucocorticoid (prednisolone at \>=0.5 mg/kg/day or 1 mg/kg every other day) for at least 4 weeks Dependent disease, defined as, 4), 5) when glucocorticoid (prednisolone doses greater than or equal to \[\>=\] 0.25 milligram per kilogram per day (mg/kg/day)or \>=0.5 milligram per kilogram (mg/kg) every other day) are needed to prevent recurrence or progression of manifestations as demonstrated by unsuccessful attempts to taper the dose to lower levels on at least 2 occasions, separated by at least 8 weeks.
* Participants must be receiving less than 3 systemic glucocorticoid therapies or other immunosuppressive therapies in addition to glucocorticoids for cGVHD for at least 4 weeks before Screening visit. The dose of steroids or Immunosuppressant must be stable for 14 days(2 weeks) prior to starting SCM-CGH or Placebo.
* Laboratory test sufficiency as follows; Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 Serum creatinine \< 2 x upper limit of normal (ULN)
Exclusion Criteria:
* Active acute graft versus host disease (GVHD)
* Active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus (HCV)
* Uncontrolled underlying disease such as moderate or severe infections and hemorrhage
* Severe Heart failure (NYHA class III/IV), congestive heart failure or arrhythmia requiring treatment
* History of allogenic hematopoietic stem cell more than once
* Positive reaction of a Penicillin test at screening
* History of relapse of causative diseases (ALL, CML, CLL, AML, NHL, multiple myeloma e.t.c.) with hematopoietic stem cell transplantation or diagnosed with secondary malignant diseases after hematopoietic stem cell transplantation
* History of Anti-thymocyte globulin(ATG) for 2 weeks before Screening visit
* History of pulmonary embolism or deep venous thrombosis for 24 weeks before Screening visit
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT04189432
Study Brief:
Protocol Section:
NCT04189432