All-Trans Retinoic Acid in Combination With Standard Induction and Consolidation Therapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia

PHASE3CompletedINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

June 30, 2004

Primary Completion Date

June 30, 2009

Study Completion Date

January 31, 2011

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

Cytarabine

100mg/m² kont. i.v. day 1-5 (induction therapy); 1000 mg/m² 2x/die i.v. day 1-3 (first consolidation cycle)

DRUG

Idarubicin

12mg/m² i.v. day 1+3 (induction therapy); 12mg/m² i.v. Tag 1+3 (second consolidation cycle)

DRUG

All-trans retinoic acid

45mg/m² p.o. day 4-6, 15mg/m² p.o. day 7-28 (induction therapy); 15mg/m² p.o. day 4-28 (consolidation therapy)

DRUG

Mitoxantrone

10mg/m² i.v. day 2-3 (first consolidation cycle)

DRUG

Etoposid

100mg/m² i.v. Tag 1-5 (second consolidation cycle)

Trial Locations (29)

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 of Innsbruck, Innsbruck

20246

Department of Oncology and Hematology, University Hospital Eppendorf, Hamburg

22763

Medical Department II, 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 of Bremen-Mitte, Bremen

30449

Medical Department III, Hospital of Hannover-Siloah, Hanover

35392

Medical Department IV, University Hospital of Giessen, Giessen

37075

Centre of Internal Medicine, University Hospital of Göttingen, Göttingen

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

I. Medical Department, Hospital of Barmerzigen Brüder, Trier

58515

Department of Hematology/Oncology, Clinical Center of Lüdenscheid, Lüdenscheid

63450

Medical Department III, Hospital of Hanau, Hanau

65929

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

66113

Department of Hematology and Oncology/Caritas Hospital St. Theresa, Saarbrücken

66421

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

66822

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

70174

Department of Oncology, Clinical Center of Stuttgart, Stuttgart

70176

Medical Department II, Diakonie Hospital, Stuttgart

76133

Medical Department II, City Hospital Karlsruhe gGmbH, Karlsruhe

78050

Medical Center II - Hematology/Oncology, Clinical Center Villingen-Schwenningen, Villingen-Schwenningen

81675

Medical Department III, Clinical Center Rechts der Isar, München

86856

Department of Internal Medicine I, Central Hospital of Augsburg, Augsburg

All Listed Sponsors
lead

University of Ulm

OTHER

NCT00151255 - All-Trans Retinoic Acid in Combination With Standard Induction and Consolidation Therapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia | Biotech Hunter | Biotech Hunter