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 @ 7:49 PM
Ignite Modification Date:
2025-12-24 @ 7:49 PM
NCT ID:
NCT04289103
Eligibility Criteria:
Inclusion Criteria:
* Patients who develop a first episode of aGvHD stage ≥ II (Przepiorka et al., 1995), resistant to a first line therapy with steroids (lack of improvement after 5 days or progression after 3 days of treatment with corticosteroids at 2 mg/Kg methylprednisolone equivalent dose)
* Age 28 days to \< 18 years old
* Allo-HSCT with any type of donor, stem cell source, GVHD prophylaxis or conditioning regimen
* Patients receiving Allo-HSCT for any indication (i.e. malignant or non-malignant disease)
* Signature of informed and written consent by the patient and/or by the patient's legally acceptable representative(s)
Exclusion Criteria:
* Isolated stage 1 skin SR-aGvHD
* Overlap chronic GvHD as defined by the NIH Consensus Criteria (Jagasia MH, 2015)
* Acute GvHD after donor lymphocytes infusion (DLI)
* Relapsed/persistent malignancy requiring rapid immune suppression withdrawal
* Other systemic drugs than corticosteroids for GvHD treatment (including extra-corporeal photopheresis). Drugs already being used for GvHD prevention (e.g. calcineurin inhibitors) are allowed.
* Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy
* Known allergy or intolerance to Leukotac of one of its ingredients
* Pregnancy: positive urinary or blood test in female of childbearing potential; lactation; absence of effective contraceptive method for female and male of childbearing potential
* Other ongoing interventional protocol that might interfere with
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
28 Days
Maximum Age:
18 Years
Study:
NCT04289103
Study Brief:
Protocol Section:
NCT04289103