First Induction Therapy:

• Cytarabine 100mg/m² cont. i.v. days 1-5

• Idarubicin 12mg/m² i.v. days 1,3

  • ATRA 45mg/m² p.o. days 4-6, ATRA 15mg/m² p.o. days 7-28
  • 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 1-5

• Idarubicin 12mg/m² i.v. days 1,3

  • ATRA 45mg/m² p.o. days 4-6, ATRA 15mg/m² p.o. days 7-28

First Consolidation Therapy:

• Cytarabine 500mg/m² bid i.v. days 1-3

• Mitoxantrone 10mg/m² i.v. days 2,3

  • ATRA 15mg/m² p.o. days 4-28

Second Consolidation Therapy

• Etoposide 100mg/m² i.v. days 1-5

• Idarubicin 12mg/m² i.v. days 1,3

  • ATRA 15mg/m² p.o. days 4-28

Condition	Intervention	Phase
Acute myeloid leukemia, age > 60 years	Drug: Cytarabine  Drug: Idarubicin  Drug: All-trans Retinoid acid  Drug: Valproic acid  Drug: Mitoxantrone	Phase III

Further Study Details: 

Primary Outcomes: event-free survival
Secondary Outcomes: Kind, incidence, severity, temporal sequence and correlation of side effects of the study drugs; CR-rate after induction therapy; cumulative incidence of relapse; cumulative incidence of death; overall survival
Expected Total Enrollment:  500

Ages Eligible for Study:  61 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00151255

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

Austria
      Department of Hematology / Oncology, University Hospital of Innbruck, Innsbruck,  6020,  Austria; Recruiting
Germany
      Department of General Internal Medicine, University Hospital of Bonn, Bonn,  53127,  Germany; Recruiting
      Department of Hematology and Oncology, Hospital Essen-Süd, Ev. Hospital of Essen-Werden, ESSEN,  45239,  Germany; Recruiting
      Department of Internal Medicine III, City Hospital Frankfurt am Main - Höchst, Frankfurt,  65929,  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 of Göttingen, Göttingen,  37075,  Germany; Recruiting
      Department of Oncology and Hematology, University Hospital Eppendorf, Hamburg,  20246,  Germany; Recruiting
      Department of Internal Medicine I, 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, Caritas Hospital Lebach, Lebach,  66822,  Germany; Recruiting
      Department of Hematology / Oncology, Clinical Center of Lüdenscheid, Lüdenscheid,  58515,  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. Theresa, Saarbrücken,  66113,  Germany; Recruiting
      Department of Oncology, Clinical Center of Stuttgart, Stuttgart,  70174,  Germany; Recruiting
      I. Medical Department, Hospital of Barmerzigen Brüder, Trier,  54292,  Germany; Recruiting
      Medical Center II - Hematology/Onkology, Clinical Center 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:  AMLSG06-04
Last Updated:  September 7, 2005
Record first received:  September 6, 2005
ClinicalTrials.gov Identifier:  NCT00151255
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-13