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ALL-SCT BFM
ALL-SCT BFM international is an open, multicentre, controlled, prospective study for therapy and therapy optimisation in patients with acute lymphoblastic leukaemia (ALL) and an indication for allogeneic hematopoietic stem cell transplantation (HSCT). The target group are children and adolescents less than 18 years old with the diagnosis ALL in first or any following remission with high risk of recurrence of their leukemia.
The main objectives are to evaluate whether HSCT from matched family or unrelated donors (MD) is equivalent to the HSCT from matched sibling donors (MSD) and to evaluate the efficacy of HSCT from mismatched family or unrelated donors (MMD) as compared to
The main objectives are to evaluate whether HSCT from matched family or unrelated donors (MD) is equivalent to the HSCT from matched sibling donors (MSD) and to evaluate the efficacy of HSCT from mismatched family or unrelated donors (MMD) as compared to
HSCT from MSD/MD. The standardisation of the treatment options during HSCT from different donor types aims at the optimal comparison of survival after HSCT with survival after chemotherapy only. The incidence of acute and chronic GvHD after HSCT from MSD, from MD and from MMD is evaluated and compared prospectively.
The primary endpoints contain event-free and overall survival after allogeneic HSCT, occurrence of acute and chronic Graft-versus-Host-Disease (GvHD), occurrence and course of late effects after chemotherapy with subsequent allogeneic HSCT.
The primary endpoints contain event-free and overall survival after allogeneic HSCT, occurrence of acute and chronic Graft-versus-Host-Disease (GvHD), occurrence and course of late effects after chemotherapy with subsequent allogeneic HSCT.
Inclusion criteria:
all patients with ALL (except patients with B-ALL) who fulfill the following criteria:
- age at time of initial diagnosis or relapse diagnosis, respectively ≤18 years
- indication for allogeneic HSCT
- complete remission (CR) is achieved before SCT
- written consent of the parents (legal guardian) and, as the case may be, of the minor patient via "Informed Consent Form"
- no pregnancy
- no secondary malignancy
- no previous HSCT
- HSCT is performed in a study participating centre.
Participating countries:
Austria
Belarus
Chile
Czech Republic
Denmark
France
Israel
Italy (Monza)
the Netherlands
Poland
Slovakia
Sweden (Lund)
TurkeyEthics committee: approved by the Ethics Committee of the University of Vienna, 15.1.2007
EudraCT Number: 2005-005106-23
international study coordinator:
Christina Peters, MD, PhD
St. Anna Kinderspital
Kinderspitalgasse 6
1090 Vienna
Austria
tel.: +43-1-40170-3106
fax: +43-1-40170-7430
email: christina.peters@stanna.at
Christina Peters, MD, PhD
St. Anna Kinderspital
Kinderspitalgasse 6
1090 Vienna
Austria
tel.: +43-1-40170-3106
fax: +43-1-40170-7430
email: christina.peters@stanna.at
technical support:
AIT Austrian Institute of Technology GmbH
Department Safety & Security
Reininghausstrasse 13
8020 Graz
Austria
tel.: +43-316-586570-0
fax: +43-316-586570-11
email: sctbfmi@ehealth-systems.at
AIT Austrian Institute of Technology GmbH
Department Safety & Security
Reininghausstrasse 13
8020 Graz
Austria
tel.: +43-316-586570-0
fax: +43-316-586570-11
email: sctbfmi@ehealth-systems.at
AIT Austrian Institute of Technology GmbH, 2008. All rights reserved