European Leukemia Trial Registry
Trial: Gravitas-301 (MEDPACE)

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Scientific Title A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids for the Treatment of First-Line Acute Graft Versus-Host Disease
Short Title Gravitas-301 (MEDPACE)
Id KN/ELN LN_NN_2018_657
Trialgroup NN
Type of Trial multicentric, randomized, placebo-kontrolliert, double-blind, double-group
Phase Phase III
Disease Acute lymphoblastic leukemia(ALL) Stem cell transplantation
Stage of Disease .
Category stem cell transplantation
Therapiestudie
Inclusion Criteria
  • Male or female, 18 years of age or older.
  • Has undergone 1 allo-HSCT from any donor (related or unrelated with any degree of HLA matching) and any donor source (bone marrow, peripheral blood stem cells, or cord blood) for a hematologic malignancy or disorder. Recipients of myeloablative and reduced-intensity conditioning regimens are eligible.
  • Clinically suspected Grade II to IV aGVHD as per MAGIC criteria, occurring after allo-HSCT and any GVHD prophylaxis regimen. Biopsies should be obtained to pathologically confirm aGVHD; in cases where a biopsy is negative, is unable to be obtained, or is clinically contraindicated, clinical suspicion of aGVHD by the treating physician is sufficient, provided that alternative diagnoses of drug effects or infection are adequately ruled out
  • Evidence of myeloid engraftment (eg, absolute neutrophil count >= 0.5 x 109/L for 3 consecutive assessments if ablative therapy was previously used). Use of growth factor supplementation is allowed.
Exclusion Criteria
  • Has received more than 1 allo-HSCT.
  • Has received more than 2 days of systemic corticosteroids for acute-GVHD.
  • Presence of GVHD overlap syndrome.
  • Presence of an active uncontrolled infection.
Age >= 18 years
Status Active
Start of Recruitment 01.02.2018
Scientific Contact Neubauer, Prof. Dr. med., Andreas (Prüfer)
Shortprotocol Shortprotocol
Sponsors Incyte Corporation
Other Registers European Clinical Trials Database - EUDRACT 2017-000538-78
created 27.01.2020 Student Studienregister
changed 27.01.2020 Student Studienregister
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