graft versus host disease profilactic use MedDRA version: 9.1 Level: LLT Classification code 10018653 Term: Graft-versus-host disease
Conditions
Interventions
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: eq
Sponsors
OSPEDALE POLICLINICO S. MATTEO
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: presence of compatible donor identified by molecolar tecnique of HLA loci A, B, C and DrB1, with more than one antigenic diparity, prior allogenic emopoietic stem cell transpltantation, use of sperimental product within 3 mounths, known or suspectied allergic reaction, ...
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate different ATG doses on acute GVHD incidence and severity.;Secondary Objective: to compare incidence of chronic GVHD in two treatment groups.;Primary end point(s): cumulative incidence of acute GVHD (grade II-IV) | — |
Countries
Italy
Outcome results
None listed