First Induction Therapy:

• Cytarabine 100mg/m² cont. i.v. days 1-7
• Idarubicin 12mg/m² i.v. days 1,3,5

• Etoposide 100mg/m² i.v. days 1-3

  • ATRA 45mg/m² p.o. days 6-8 ATRA 15mg/m² p.o. days 9-21
  • Valproic acid 400mg bid i.v. days 1-2 thereafter p.o. retard formulation plasma-level-adapted, aspired plasma-level 100mg/l (60-150mg/l)

Second Induction Therapy:

• Cytarabine 100mg/m² cont. i.v. days 1-7
• Idarubicin 12mg/m² i.v. days 1,3,5

• Etoposide 100mg/m² i.v. days 1-3

  • ATRA 45mg/m² p.o. days 6-8 ATRA 15mg/m² p.o. days 9-21
  • Valproic acid p.o. Retard formulation plasma-level-adapted, aspired plasma-level 100mg/l (60-150mg/l)

Consolidation Therapy:

• Cytarabine 3g/m² bid i.v. days 1,3,5

  • ATRA 15mg/m² p.o. days 6-21
  • Valproic acid p.o. Retard formulation plasma-level-adapted, aspired plasma-level 100mg/l (60-150mg/l)
• Pegfilgrastim 6mg s.c day 10

Condition	Intervention	Phase
Acute Myeloid Leukemia	Drug: Cytarabine  Drug: Idarubicin  Drug: Etoposide  Drug: all-trans retinoic acid  Drug: Valproic acid  Drug: Pegfilgrastim	Phase II

Further Study Details: 

Primary Outcomes: CR-rate after induction therapy
Secondary Outcomes: Kind, incidence, severity, temporal sequence and correlation of side effects of the study-drugs; cumulative incidence of relapse; cumulative incidence of death; Overall survival; Event-free survival; Hematological recovery as well as incidence and duration of infections during neutropenia after each consolidation cycle Days in hospital after each consolidation cycle; Timely sequence of the Pegfilgrastim-concentration in correlation to the absolute neutrophile counts after each consolidation cycle
Expected Total Enrollment:  304

Ages Eligible for Study:  18 Years   -   60 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Newly diagnosed AML defined according to the WHO-classification (excluding APL) - Age 18-60 years
• Written informed consent of each patient at study entry.
• Molecular and cytogenetical diagnostics on initial bone marrow and peripheral blood specimen at the central reference laboratories

Exclusion Criteria:

• Bleeding independent of the AML
• Acute promyelocytic leukemia
• Uncontrollable infection
• Participation in a concurrent clinical study
• Insufficiency of the kidneys (Crea >1.5x upper normal serum level), of the liver (bilirubine, AST or AP > 2x upper normal serum level), severe obstructive or restrictive ventilation disorder, heart failure NYHA III/IV
• Severe neurological or psychiatric disorder interfering with ability to give an informed consent.
• No consent for registration, storage and processing of the induvidual disease-characteristics and course.
• Performance status WHO > 2
• Pregnancy

Please refer to this study by ClinicalTrials.gov identifier  NCT00151242

Richard F Schlenk, Dr.      0049-(0)731-500-  Ext. 24418    richard.schlenk@medizin.uni-ulm.de

Austria
      Department of Hematology/Oncology, University Hospital Innsbruck, Innsbruck,  6020,  Austria; Recruiting
Germany
      Department of General Internal Medicine, University Hospital of Bonn, Bonn,  53127,  Germany; Recruiting
      Clinical Center of Hematology and Oncology, University Hospital of Düsseldorf, Düsseldorf,  40225,  Germany; Recruiting
      Department of Hematology and Oncology, Hospital Essen Süd, Ev. Hospital of Essen-Werden, ESSEN,  45239,  Germany; Recruiting
      Medical Department III, Hematology / Oncology, University of Frankfurt, Frankfurt,  60590,  Germany; Recruiting
      Department of Internal Medicine III, City Hospital Frankfurt am Main - Höchst, Frankfurt,  65929,  Germany; Recruiting
      Internal Medicine I, University of Freiburg, Freiburg,  79106,  Germany; Recruiting
      Medical Department IV, University Hospital of Giessen, Giessen,  35392,  Germany; Recruiting
      Department of Internal Medicine, Wilhelm-Anton-Hospital gGmbH, Goch,  47574,  Germany; Recruiting
      Centre of Internal Medicine, University Hospital Göttingen, Göttingen,  37075,  Germany; Recruiting
      II. Medical Department, Hematology and Oncology, General Hospital Altona, Hamburg,  22763,  Germany; Recruiting
      Department of Oncology and Hematology, University Hospital Eppendorf, Hamburg,  20246,  Germany; Recruiting
      Medical Department III, Clinical Center Hanau, Hanau,  63450,  Germany; Recruiting
      Department of Hematology Hemastaseology and Oncology, Medizinische Hochschule Hannover, Hannover,  30625,  Germany; Recruiting
      Department of Internal Medicine !, University Hospital of Saarland, Homburg,  66421,  Germany; Recruiting
      Medical Department II, City Hospital Karlsruhe gGmbH, Karlsruhe,  76133,  Germany; Recruiting
      Medical Department II, University Hospital of Kiel, Kiel,  24116,  Germany; Recruiting
      Department of Internal Medicine / Hematology and Oncology, Cartias Hospital Lebach, Lebach,  66822,  Germany; Recruiting
      Department of Hematology and internal Oncology, University Hospital of Mainz, Mainz,  55101,  Germany; Recruiting
      Medical Department III, Clinical Center rechts der Isar, München,  81675,  Germany; Recruiting
      Department of Hematology and Oncology, Clinical Center of Oldenburg gGmbH, Oldenburg,  26133,  Germany; Recruiting
      Department of Hematology and Oncology, Caritas Hospital St. Theresia, Saarbrücken,  66113,  Germany; Recruiting
      Department of Oncology, Clinical Center of Stuttgart, Stuttgart,  70174,  Germany; Recruiting
      I. Medical Department, Hospital of Barmherzige Brüder, Trier,  54292,  Germany; Recruiting
      Department of Internal Medicine II, University Hospital of Tübingen, Tübingen,  72076,  Germany; Recruiting
      Medical Clinic II- Hematology/Oncology, Hospital Villingen-Schwenningen, Villingen-Schwenningen,  78050,  Germany; Recruiting
      Medical Department I, Helios Hospital Wuppertal, Wuppertal,  42283,  Germany; Recruiting

Study chairs or principal investigators

Richard F Schlenk, Dr.,  Principal Investigator,  Department of Internal Medicine III / University of Ulm   

Study ID Numbers:  AMLSG07-04
Last Updated:  September 7, 2005
Record first received:  September 6, 2005
ClinicalTrials.gov Identifier:  NCT00151242
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-13