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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT03371667
Eligibility Criteria:
Inclusion Criteria:
* Adults patients (\>=18 years old) with hematological diseases, who develop a first episode of acute GVHD (grade II-IV) requiring systemic therapy
* First allo-SCT, with any type of donor, stem cell source, GVHD prophylaxis or conditioning regimen
* Biopsy of acute GVHD target organ is recommended, but not required. Enrollment should not be delayed awaiting biopsy or pathology results
* The patient must have received no previous systemic immune suppressive therapy for treatment of acute GVHD, except for a maximum 72 hours of prior corticosteroid therapy
* Absolute neutrophil count (ANC) greater than 0.5 G/L
* Platelets count greater than 20 G/L
* Signed informed consent
* Affiliation to a social security system (recipient or assign)
* Women who are of childbearing potential must have a negative serum pregnancy test and agree to use a medically acceptable method of contraception until 6 months after the end of treatment.
Men with a partner of childbearing potential must agree to use a medically acceptable method of contraception until 6 months after the end of treatment.
Exclusion Criteria:
* Hyper-acute GVHD as defined by the MD Anderson's criteria (Saliba, de Lima et al. 2007)
* Flare of GVHD in a patient already on corticosteroid treatment
* Overlap chronic GVHD as defined by the NIH Consensus Criteria (Jagasia, Greinix et al. 2015)
* MTX given within 7 days of enrollment
* Active uncontrolled infection
* Relapsed/persistent malignancy requiring rapid immune suppression withdrawal
* Acute GVHD after donor lymphocytes infusion (DLI)
* Other systemic drugs for GVHD treatment (including extra-corporeal photopheresis)
* If any prior steroid therapy (for indication other than GVHD), treatment at doses \> 0.5 mg/kg/day methyl-prednisolone within 7 days prior to onset of acute GVHD
* Patients who are pregnant, breast feeding, or if sexually active, unwilling to use effective birth control for the duration of the study
* Patient on dialysis
* Patients with veno-occlusive disease of the liver or with significant liver abnormalities who in the judgment of the treating physician cannot receive MTX
* Patients requiring after inclusion in the protocol the continuation of one or more of the following medication: probenecide, trimethoprime (alone or in combination with sulfametoxazole), phenylbutazone or yellow fever vaccine
* Patients with a history of intolerance/allergy to MTX
* Hypersensitivity to the active substance or to any of the excipients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03371667
Study Brief:
Protocol Section:
NCT03371667