Study on All-Trans Retinoic Acid, Induction and Consolidation Therapy, and Pegfilgrastim After Consolidation Therapy in Younger Patients With Newly Diagnosed Acute Myeloid Leukemia

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

920

Participants

Timeline

Start Date

July 31, 2004

Primary Completion Date

August 31, 2011

Study Completion Date

August 31, 2013

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

Cytarabine

100mg/m² kont. i.v. day 1-7 (induction therapy) 3g/m² 2x/die i.v. day 1,3,5 or day 1,2,3

DRUG

Idarubicin

12mg/m² i.v. day 1,3,5 (first induction cycle) 12mg/m² i.v. Tag 1,3 (second induction cycle)

DRUG

Etoposide

100mg/m² i.v. day 1-3 (induction therapy)

DRUG

All-trans retinoic acid

45mg/m² p.o. day 6-8 (induction therapy) 15mg/m² p.o. day 9-21 (induction therapy) 15mg/m² p.o. day 6-21 (consolidation therapy)

DRUG

Pegfilgrastim

6mg s.c day 10 (cohort 1), 6mg s.c. day 8 (cohort 2)

Trial Locations (34)

1140

Center of Hematology and Oncology, Hanusch-Hospital, Vienna

4010

Department of Internal Medicine I, Krankenhaus der Barmherzigen Schwestern, Linz

5020

Medical Department III, St. Johann-Hospital, Salzburg

6020

Department of Hematology/Oncology, University Hospital Innsbruck, Innsbruck

20246

Department of Oncology and Hematology, University Hospital Eppendorf, Hamburg

22763

Medical Department II, Hematology and Oncology, General Hospital Altona, Hamburg

24116

Medical Department II, University Hospital of Kiel, Kiel

26133

Department of Hematology and Oncology, Clinical Center of Oldenburg gGmbH, Oldenburg

28177

Medical Department I, Hospital Bremen-Mitte, Bremen

30449

Medical Department III, Hospital Hannover-Siloah, Hanover

30625

Department of Hematology, Hematology and Oncology, Medizinische Hochschule Hannover, Hanover

35392

Medical Department IV, University Hospital of Giessen, Giessen

37075

Centre of Internal Medicine, University Hospital Göttingen, Göttingen

40225

Clinical Center of Hematology and Oncology, University Hospital of Düsseldorf, Düsseldorf

42283

Medical Department I, Helios Hospital Wuppertal, Wuppertal

45239

Department of Hematology and Oncology, Hospital Essen Süd, Ev. Hospital of Essen-Werden, Essen

47574

Department of Internal Medicine, Wilhelm-Anton-Hospital gGmbH, Goch

53127

Department of General Internal Medicine, University Hospital of Bonn, Bonn

54292

Medical Department I, Hospital of Barmherzige Brüder, Trier

55101

Department of Hematology and Internal Oncology, University Hospital of Mainz, Mainz

58505

Department of Hematology and Oncology, Hospital of Lüdenscheid, Lüdenscheid

60590

Medical Department III, Hematology/Oncology, University of Frankfurt, Frankfurt

63450

Medical Department III, Clinical Center Hanau, Hanau

65929

Department of Internal Medicine III, City Hospital Frankfurt am Main - Höchst, Frankfurt

66113

Department of Hematology and Oncology, Caritas Hospital St. Theresia, Saarbrücken

66421

Department of Internal Medicine I, University Hospital of Saarland, Homburg

66822

Department of Internal Medicine/Hematology and Oncology, Cartias Hospital Lebach, Lebach

70174

Department of Oncology, Clinical Center of Stuttgart, Stuttgart

70176

Medical Department II, Diakonie Hospital, Stuttgart

72076

Department of Internal Medicine II, University Hospital of Tübingen, Tübingen

76133

Medical Department II, City Hospital Karlsruhe gGmbH, Karlsruhe

78050

Medical Clinic II-Hematology/Oncology, Hospital Villingen-Schwenningen, Villingen-Schwenningen

79106

Internal Medicine I, University of Freiburg, Freiburg im Breisgau

81675

Medical Department III, Clinical Center Rechts der Isar, München

All Listed Sponsors
lead

University of Ulm

OTHER

NCT00151242 - Study on All-Trans Retinoic Acid, Induction and Consolidation Therapy, and Pegfilgrastim After Consolidation Therapy in Younger Patients With Newly Diagnosed Acute Myeloid Leukemia | Biotech Hunter | Biotech Hunter