1. To evaluate whether stem cell transplantation from a matched sibling donor is equivalent to a matched unrelated donor in in a second complete remission of acute myeloid leukemia (AML). 2. To evaluate whether stem cell transplantation (SCT) after chemotherapy (FLAMSA-schema) increases survival compared to a threshold derived from historical data 3. To evaluate whether SCT from haploidentical donors for children having no matched donor will result in better survival with acceptable toxicity.
Target variables: * Treatment response * Event Free Survival * Leukemia Free Survival * Graft Versus Host Disease * Regimen related toxicity
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
154
\> = 2 x 10\*8 nucleated cells (WBC)/kg body weight of the recipient or rather \> = 4 x 10\*6 nucleated CD34+ cells / kg body weight are required for engraftment. Suspension of stem cells is administered via intravenous infusion.
Graz University Hospital
Graz, Austria
To evaluate whether stem cell transplantation (SCT) from a matched sibling donor (MSD) is equivalent to a matched unrelated donor (MUD) in second complete remission (CR2).
Time frame: day 100
To evaluate whether "FLAMSA" increases leukemia free survival (LFS) and overall survival (OS) as compared to a historic control group
Time frame: day 100
To evaluate whether SCT from haploidentical donors for children having no matched donor will result in an acceptable toxicity profile and a better LFS as compared to historic controls.
Time frame: day 100
Prospective evaluation of event free survival (EFS), LFS, and OS after SCT from either a MSD or a MUD
Time frame: day 100
To evaluate whether it is feasible to standardize transplantation procedures in children with AML within the AML-Berlin/Frankfurt/Münster (BFM) study network
Time frame: day 100
Decrease of transplantation associated mortality by standardized donor selection criteria
Time frame: day 100
To further evaluate the contribution of immunomediated effects for the treatment of children suffering from very high risk AML
Time frame: day 100
Prospective evaluation of late toxicities
Time frame: day 100 and year 5
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Innsbruck, Austria
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Prague, Czechia
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Freiburg im Breisgau, Baden-Wurttemberg, Germany
Heidelberg University Hospital
Heidelberg, Baden-Wurttemberg, Germany
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Tübingen, Baden-Wurttemberg, Germany
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Ulm, Baden-Wurttemberg, Germany
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Erlangen, Bavaria, Germany
Dr. von Haunersches Kinderspital
München, Bavaria, Germany
...and 14 more locations