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. - ND
- Conditions
- graft versus host disease profilactic useMedDRA version: 9.1Level: LLTClassification code 10018653Term: Graft-versus-host disease <GVHD>
- Registration Number
- EUCTR2008-000101-11-IT
- Lead Sponsor
- OSPEDALE POLICLINICO S. MATTEO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
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, ...
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method