Please select the eligibility criteria that correspond to the clinical trial below.
Title: Multicenter Therapy-Optimization Trial AML-BFM 2004 for the Treatment of Acute Myeloid Leukemias in Children and Adolescents
Brief Summary: Due to progressive therapy intensification in the four consecutive studies AML-BFM 78, 83, 93 and 98, prognosis for children with acute myeloid leukemia (AML) has improved steadily. In spite of the intensified therapy, rates of morbidity and mortality have remained unchanged or have even decreased. Against the background that about 40% of the patients still die from immediate causes of an underlying disease relapse or of nonresponse, it seems to be justifiable to intensify therapy - especially for high-risk patients - which on its parts will require an optimization of supportive measures. As the present risk stratification into standard- (SR) and high-risk (HR) patients has proved effective, we will pursue the risk-adapted therapy strategy.

The aim of the study is to improve prognosis in children with AML by intensification of cytostatic therapy and to evaluate by randomisation the equivalence of a prophylactic central nervous system (CNS) irradiation with a total dose of 18 Gy versus 12 Gy.


Options:
A: Inclusion Criteria:

* Age from \>0 to \</=18 years
* De novo AML, including children with Down syndrome, primary myelosarcomas or acute mixed lineage leukemia/biphenotypic leukemia (predominantly myeloid)
* Admission to one of the member hospitals in Germany participating in the study AML-BFM 2004

Exclusion Criteria:

* Children with pre-existing syndromes (except Down syndrome)
* AML as secondary malignancy
* Accompanying diseases which do not allow therapy according to the protocol
* Pre-treatment for more than 14 days with another intensive induction therapy
B: Inclusion Criteria:

* diagnosis of de-novo AML, FAB M 1, 2, 4 - 7
* diagnosis of secondary AML after chemo-/radiotherapy or MDS
* diagnosis of RAEB-T
* age between 16 and 60 years (including 60 years)
* women after exclusion of pregnancy
* written informed consent

Exclusion Criteria:

* patients with severe disease of the heart (e.g. cardial failure NYHA III/IV; history of myocardial infarction within the last 6 months;severe ventricular arrythmias (Lown III to IV)
* patients with DLCO \< 50%
* patients with creatinine clearance \< 60 ml/min
* patients with bilirubin \> 2mg% (34.2 mmol/L)
* patients with severe complications of the leukaemia such as uncontrolled bleeding, pneumonia with hypoxia or shock
* patients with a psychiatric, addictive, or any disorder which compromises ability to give truly informed consent for participating in this study
* HIV positivity
* patients with a t(15;17) translocation
C: Inclusion Criteria:

Male or female aged 65 years or more. Patient with previously untreated AML except M3 in the FAB classification. Patient with previously untreated transformed refractory anemia with excess blasts (RAEB-t).

Patients with AML secondary to a previously untreated myelodysplastic syndrome (MDS), documented or not, are eligible, as well as those with RAEB-t evolving from a previous known MDS.

Patients with a Performance Status \< 3. Patient who has given his/her written informed consent.

Exclusion Criteria:

Patients with AML3 in the FAB classification. Patients with blast crisis of previously known myeloproliferative syndrome. Patients with AML secondary to previous treatment with cytotoxic chemotherapy or radiotherapy (therapy-related AML).

Patients with another concommitant neoplasia. Patients with leukemic central nervous system involvement. Patients with a Grade \> 2 uncontrolled infection. Patients with Grade \> 2 visceral contra-indications to treatment with induction chemotherapy (except if leukemia-related).

Bilirubin \> 2 times the normal range of the laboratory. Serum creatinine \> 2 times the normal range of the laboratory. Patients with cardiac contra-indication to treatment with anthracyclines.
D: Inclusion Criteria:

Adult patients \< or = 60 years acute myelogenous leukemia (AML) AML t(8;21)(q22;q22), AML1 (CBFa)/ETO, AML(inv(16)(p13q22)) und variants (CBFb/MYH11), AML 11q23, MLL-anomalies, AML with normal karyotyp myelodysplastic syndrome (MDS)RAEBT with 20-30% blasts.

de novo AML secundary AML after MDS secundary AML after chemotherapy with alkylantien sekundäre AML after chemotherapy with Epipodophyllotoxin informed consent

Exclusion Criteria:

AML M3 patients included in another clinical trial contraindications for high dose cytotoxic therapy such as renal insufficiency liver insufficiency cardiac insufficiency NYHA III + IV, acute myocardial infarction uncontroled infection like pneumonia with hypoxemia or septic schock pregnancy Karnofski-Index of 10 and less second maligancy severe, decompensated metabolism disorders

Answer: A