Multicenter, prospective, randomized clinical trial to assess two different doses of anti-human-T-lymphocyte immune serum preparation derived from rabbit in GVHD profilaxis in pediatric population with haematologic malignancies riceiving non allogenic stem cell transplantation.

Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2008
INTERVENTION: Trade Name: ATG‐Fresenius Pharmaceutical Form: Solution for infusion INN or Proposed INN: Antithymocyte immunoglobulin (rabbit) Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20‐ CONDITION: graft versus host disease profilactic use ; MedDRA version: 9.1 Level: LLT Classification code 10018653 Term: Graft‐versus‐host disease PRIMARY OUTCOME: Main Objective: to evaluate different ATG doses on acute GVHD incidence and severity. Primary end point(s): cumulative incidence of acute GVHD (grade II‐IV) Secondary Objective: to compare incidence of chronic GVHD in two treatment groups. INCLUSION CRITERIA: patients affected with LLA, LMA, LNH, LMC Ph+ RC, AREB, AREB‐t, LMMC; age 0‐19 years; written inform consensus; ... Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Epistemonikos ID: 855860d731d5043443f33962bb343501b087356d
First added on: Aug 21, 2024