Status:
UNKNOWN
Randomized Study of ATG for Graft Versus Host Disease (GVHD) Prevention in Paediatric Patients Given an Unrelated Donor Stem Cell Transplantation
Lead Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Collaborating Sponsors:
Italian Association for Pediatric Hematology Oncology
Conditions:
Paediatric Patients Affected by Haematological Malignancies and Eligible to Undergo HSCT From an Unrelated Volunteer
Eligibility:
All Genders
1-19 years
Phase:
PHASE3
Brief Summary
Paediatric patients affected by haematological malignancies and eligible to undergo HSCT from an unrelated volunteer will be stratified according to the degree of compatibility with their donor, the s...
Detailed Description
Study rationale Several reports have documented that patients given HSCT from an unrelated volunteer have: * Increased incidence and severity of acute GVHD; * Increased incidence and severity of chr...
Eligibility Criteria
Inclusion
- Unrelated donor selected using high-resolution molecular typing of HLA-A, B, C and DrB1 loci, perfectly matched or with a single allelic disparity at one of the HLA loci or with 2 allelic disparities and with an antigenic disparity at the HLA loci;
- Age comprised between 0 and 19 years;
- Life-expectancy of at least 2 months;
- Use of G-CSF mobilized PB- or BM-derived haematopoietic stem cells
Exclusion
- Unrelated donor selected using high-resolution molecular typing of HLA-A, B, C and DrB1 loci, with more than one antigenic disparity or more than 2 allelic disparities at the HLA loci;
- Previous allogeneic HSCT;
- Cord blood as source of haematopoietic stem cells;
- Previous treatment with rabbit ATG in the last 3 months before HSCT;
- History of allergic reactions to rabbit ATG;
- Absence of written informed consent.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00934557
Start Date
March 1 2008
Last Update
July 8 2009
Active Locations (1)
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1
Franco Locatelli
Pavia, Pavia, Italy, 27100