Allogenic Stem Cell Transplantation for Children, Adolescents and Young Adults With Relapsed or Refractory AML

Allogenic Stem Cell Transplantation for Children, Adolescents and Young Adults With Relapsed or Refractory AML; Multi Center Therapy Concept

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

Inclusion Criteria:

• Aged between 0-21 years
• Patients suffering from either refractory de novo AML or relapsed AML or patients with very high risk AML in CR1
• In sexually active patients two reliable contraception methods are used. This includes every combination of a hormonal contraceptive (such as injection, transdermal patch, implant, cervical ring) or of an intrauterine device(IUD) with a barrier method (e.g. diaphragm, cervical cap, or condom) or with a spermicide.
• Written informed consent of patient, parents or legal guardians

Exclusion Criteria:

• Severe renal impairment (GFR < 30% predicted for age)
• Pregnant or lactating females
• Current participation in another clinical trial
• Patients ≥ 12 years old for Group 1 ("BuCyMel") (patients younger that 12 years continue to be included)