The goal of this trial is to compare the outcome after partially matched (single mismatch) unrelated donor transplantation with haploidentical transplantation in a randomized controlled setting.
For patients with an indication for allogeneic HCT, the search for a stem cell donor is a challenge. 20% of patients who need an allograft have an HLA-identical sibling available, and for approximately 70% of the remaining patients, a suitable, HLA-well-matched (10/10), unrelated volunteer can be found. For the remaining patients, partially matched (single mismatch) unrelated donors or haploidentical donors are alternative options. Recently published retrospective single center and registry studies suggest comparable outcomes for HCT from unrelated donors matched at HLA -A, -B, -C, and -DRB1 and haploidentical donors. The number of haploidentical HCT evaluated in these studies was still relatively small and a selection bias for the retrospective comparisons cannot be excluded. The goal of this trial is to evaluate overall survival of patients with high-risk AML, ALL or MDS after partially matched unrelated or haploidentical donor transplantation..
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
98
Hematopoietic stem cell transplantation with PBSC
Universitätsklinikum Bonn
Bonn, Germany
Universitätsklinikum Dresden
Dresden, Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, Germany
Universitätsklinikum Halle (Saale)
Halle, Germany
Overall survival
Overall survival calculated from the time of randomization will be the primary endpoint of this trial. Death from any reason will be considered as event.
Time frame: 2 years
Engraftment rate
Engraftment
Time frame: day 56
Immune-reconstitution rate
Immune-reconstitution rate
Time frame: day56
Infections
Severe infections rate
Time frame: 2 months after HCT
Event Free Survival
Event Free Survival
Time frame: 1 year
Graft vs Host Disease
Graft vs Host Disease rate
Time frame: 1 year
Graft vs Host Disease-free survival
Graft vs Host Disease-free survival rate
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Universitätsmedizin Mannheim
Mannheim, Germany
Universitätsklinikum Münster
Münster, Germany
Klinikum Nürnberg Nord
Nuremberg, Germany
Robert-Bosch-Krankenhaus
Stuttgart, Germany
Universitätsklinikum Tübingen
Tübingen, Germany