AML SCT-BFM 2007

Study objectives

1. To evaluate whether stem cell transplantation from a matched sibling donor is equivalent to a matched unrelated donor in a second complete remission.
2. To evaluate whether “FLAMSA” increases survival as compared to a survival rate estimated from historical data (studies AML-BFM and Relapsed AML 2001/1, 1-year pSurvival 10%) in children suffering from refractory AML or relapsed AML responding poorly to reinduction therapy.
3. To evaluate whether stem cell transplantation from haploidentical donors for children having no matched donor increases survival as compared to a survival rate estimated from historical data (studies AML-BFM and Relapsed AML 2001/1) in children suffering from refractory AML or relapsed AML .

1. Young patients achieving a second complete remissio (CR2) after reinduction will undergo SCT if a matched related donor or a matched unrelated donor is available. The reparative regimen will consist of Bu/Cy Mel +/- ATG.
2. Young patients achieving CR2 after reinduction may qualify for haploidentical stem cell transplantation if no matched related donor or matched unrelated donor is available. The preparative regimen will consist of Flud/TT/Mel (OKT3).
3. Young patients with newly diagnosed refractory AML* will qualify for “FLAMSA” if a matched related donor or a matched unrelated donor is available. The same group will qualify for haploidentical SCT in combination with 2-CDA/Cytarabine if no matched related donor/matched unrelated donor is available for SCT 8 weeks after criteria of refractory AML are met.
4. Young patients with relapsed AML will qualify for “FLAMSA” if the following two requirements are met: a) The bone marrow aspirate performed on day 28 after reinduction will still contain > 20% blasts, b) Availability of a matched related/matched unrelated donor.
5. Young patients with relapsed AML will qualify for SCT from a haploidentical donor if the following requirements are met: a) No availability of a matched related/matched unrelated donor for SCT 8 weeks after diagnosis.

• Aged between 0-21 years
• Patients suffering from either refractory de novo AML or relapsed AML
• Contraception of female adolescents and young adults or male partners
• Written informed consent of patient, parents or legal guardians

• Severely impaired functional performance (Karnofsky score < 70%, Lansky play score < 70%)
• Severe renal impairment (GFR < 30% predicted for age)
• Pregnant or lactating females
• Current participation in another clinical trial