Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III Trial in Adult Acute Myeloid Leukemia: Daunorubicin Dose-Intensification Prior to Risk-Allocated Autologous Stem Cell Transplantation
Brief Summary: RATIONALE: Giving combination chemotherapy before a stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the transplanted stem cells. When the healthy stem cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. If the patient's stem cells are to be transplanted, the patient is also treated with a monoclonal antibody, such as gemtuzumab ozogamicin, to kill any remaining cancer cells or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without gemtuzumab ozogamicin followed by stem cell transplant in treating acute myeloid leukemia.

PURPOSE: This randomized phase III trial is studying combination chemotherapy, gemtuzumab ozogamicin, and stem cell transplant to see how well they work compared to combination chemotherapy and peripheral stem cell transplant alone in treating patients with acute myeloid leukemia.


Options:
A: Inclusion Criteria:

* Morphologically confirmed acute myeloid leukemia (AML) (greater than 20% blasts in the peripheral blood or marrow) meeting any of the following criteria:

  * Recurrent cytogenetic translocations

    * t(8;21)(q22;q22)
    * Bone marrow eosinophil abnormalities

      * inv(16)(p13;q22)
      * t(16;16)(p13;q22)
    * 11q23 abnormalities
  * Multilineage dysplasia without presence of myelodysplastic syndromes (MDS)
  * Minimally differentiated AML
  * AML without maturation
  * AML with maturation
  * AML not otherwise categorized
  * Acute myelomonocytic leukemia
  * Acute monocytic leukemia
  * Acute erythroid leukemia
  * Acute megakaryocytic leukemia
  * Acute basophilic leukemia
* Patients undergoing allogeneic transplantation must have a sibling donor match defined as human leukocyte antigen (HLA) match or haplotype match with one locus mismatch on other haplotype
* Age 16 to 60
* Eastern Cooperative Oncology Group (ECOG) performance status 0-4
* Aspartate aminotransferase (AST) less than 4 times upper limit of normal (ULN)
* Alkaline phosphatase less than 4 times ULN
* Creatinine no greater than 2.0 mg/dL
* Creatinine clearance at least 50 mL/min
* Left ventricular ejection fraction (LVEF) at least 45% by post-induction multigated acquisition (MUGA) scan
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* Prior hydroxyurea allowed
* Prior corticosteroids allowed

Exclusion Criteria:

* Recurrent cytogenetic translocations

  * Acute promyelocytic leukemia (PML) with t(15;17)(q22;q21)
  * Variant acute PML with t(v;17)
* Multilineage dysplasia with prior MDS
* Acute panmyelosis with myelofibrosis

  * Blastic transformation of chronic myelogenous leukemia
  * Secondary AML (chemotherapy-induced or evolved from MDS)
  * Pregnant or nursing
  * Bilirubin greater than 2.0 mg/dL (unless related to Gilbert's syndrome or hemolysis)
  * Significant cardiac disease requiring active therapy (e.g., digoxin, diuretics, antiarrhythmics, or antianginal medications)
  * Prior biologic therapy
  * Prior cytotoxic chemotherapy for any malignancy
  * Prior radiotherapy for any malignancy
B: 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
C: Inclusion Criteria:

* de novo or secondary acute myeloid leukemia FAB-subtypes M0-M2 and M4-M7
* de novo or secondary myelodysplastic syndrome WHO-type RAEB-2
* age 16 to 60 years
* written informed consent

Exclusion Criteria:

* severe comorbidities
* severe, uncontrolled complications of the leukemia
* prior therapy for AML/MDS
* other simultaneous hematological malignancies
* HIV-Infection
* known allergies against study medication
* pregnancy
* missing written informed consent
D: Inclusion Criteria:

* Patients with AML, de Novo or secondary after Myelodysplasy, or with therapy-induced AML after healed primary malignom; or refractory anemia with excess of blasts in transformation (RAEB-t); the diagnosis must be confirmed morphological, cytochemical and with immunological phenotyping
* Cytogenetical tests must be performed for each patient
* Age: 16 - 60 years
* All patients have to be informed about the character of the study. Written informed consent of each patient at study entry.

Exclusion Criteria:

* Organic insufficiency: Insufficiency of the kidneys (Crea \> 1.5 x upper normal serum level), or insufficiency of the liver (bilirubin, SGOT or AP \> 2 x upper normal serum level) uncaused by the AML; severe obstruction or restrictive ventilation disorder, heart failure with a ejection fraction \< 0.5
* Secondary malignom
* Other severe diseases
* Pregnancy
* Participation in an concurrent clinical study

Answer: A