Phase III Randomized Study of Amonafide (AS1413) and Cytarabine Versus Daunorubicin and Cytarabine in Patients With Secondary Acute Myeloid Leukemia (AML)- the ACCEDE Study

PHASE3UnknownINTERVENTIONAL
Enrollment

420

Participants

Timeline

Start Date

June 30, 2007

Primary Completion Date

June 30, 2010

Conditions
Secondary Acute Myeloid Leukemia (Secondary AML, sAML)
Interventions
DRUG

Daunorubicin and Cytarabine

Daunorubicin: 45 mg/m2 over 30 minutes daily on days 1-3 (up to max. of 2 courses) Cytarabine: 200 mg/m2 IV continuous infusion daily on days 1-7 (up to max. of 2 courses)

DRUG

Amonafide and Cytarabine

Amonafide: 600 mg/m2 IV over 4 hours daily on Days 1-5 (up to max. 2 courses) Cytarabine: 200 mg/m2 IV continuous infusion daily on Days 1-7 (up to max. 2 courses)

Trial Locations (158)

100

National Taiwan University Hospital (NTUH), Taipei

104

Mackay Memorial Hospital, Taipei

112

Veterans General Hospital Taipei (VGH-TP), Taipei

404

Chinese Medical University Hospital (CMUH), Taichung

500

Changhua Christian Hospital (CCH), Changhua

704

National Cheng Kung University Hospital (NCKUH), Tainan City

1000

Institut Jules Bordet, Brussels

1097

Szent Istvan and Szent Laszlo Corporate Hospital - Out-patient Clinic of the Municipality Government, Budapest

2065

Royal North Shore Hospital, St Leonards

2145

Westmead Hospital, Westmead

2605

The Canberra Hospital, Garran

3002

Peter MacCallum Cancer Centre, Melbourne

3004

The Alfred Hospital, Melbourne

3100

Landesklinikum St. Polten, Sankt Pölten

5000

Royal Adelaide Hospital, Adelaide

5020

Landeskrankenhaus Salzburg, Salzburg

5530

UCL de Mont-Godinne, Yvoir

6000

Royal Perth Hospital, Perth

7400

Kaposi Mór County Teaching Hospital, Kaposvár

8000

Algemeen Ziekenhuis Sint-Jan, Bruges

8036

LKH-Universitats Klinikum Graz, Graz

9000

University Hospital Gent, Ghent

9024

Petz Aladar County Teaching Hospital, Győr

10013

O.F. Herbachevsky Zhytomyr Regional Clinical Hospital, Zhytomyr

11042

Northshore Hospital - Monter Cancer Center, Lake Success

12200

Charite - Campus Benjamin Franklin, Berlin

13353

Campus Virchow Klinikum, Berlin

13419

North Estonia Medical Centre Foundation, Tallinn

14263

Roswell Park Cancer Institute, Buffalo

15224

Western Pennsylvania Hospital, Pittsburgh

16132

A.O.U San Martino, Genova

17036

Penn State Hershey Medical Center, Hershey

18009

Public Institution 'Cherkasy Regional Oncology Center', Cherkasy

19107

Thomas Jefferson University, Philadelphia

20089

Istituto Clinico Humanitas, Rozzano

21018

M.I. Pyrohov Vinnytsya Regional Clinical Hospital, Vinnytsia

22763

Asklepios Kliniken Altona, Hamburg

24116

Universitätsklinikum Schleswig-Holstein, Kiel

25123

University of Brescia, Brescia

27157

Wake Forest University Health Sciences, Winston-Salem

27707

Duke University Medical Center, Durham

29000

Khmelnytsky Regional Hospital, Khmelnytsky

29425

Medical University of South Carolina, Charleston

29605

Cancer Center of the Carolinas, Greenville

30322

Winship Cancer Institute, Emory University, Atlanta

30342

The Blood and Marrow Transplant Group of GA, Atlanta

30625

Medizin Hochschule Hannover, Hanover

31096

Rambam Medical Center, Haifa

33604

Hopital du Haut Leveque, Pessac

37044

Hopital Bretonneau - CHRU de Tours, Tours

37203

Sarah Cannon Research Institute, Nashville

40202

James Graham Brown Cancer Center, Louisville

44195

Taussig Cancer Center, Cleveland Clinic, Cleveland

45122

Universitatsklinikum Essen, Essen

48109

University of Michigan Cancer Center, Ann Arbor

48910

Michigan State University, Lansing

49102

Dnipropetrovsk City General Clinical Hospital #4, Dnipropetrovsk

50134

A.O.U Careggi, Florence

51375

Klinikum Leverkusen, Leverkusen

52242

University of Iowa Hospitals, Iowa City

52249

St Antonius Hospital, Eschweiler

52621

Chaim Sheba Medical Center, Tel Litwinsky

53113

Evangelische Kliniken GmbH, Bonn

54058

Mykolaiv Regional Clinical Hospital, Mykolaiv

56125

A.O.U Pisana Santa Chiara, Pisa

58515

Markische Kliniken GmbH Klinikim Ludenscheid, Lüdenscheid

60611

Northwestern University School of Medicine, Chicago

60612

Rush University Medical Center, Chicago

61100

A.O. San Salvatore, Pesaro

65025

Odesa Regional Clinical Hospital, Odesa

65929

Stadtische Kliniken Frankfurt, Frankfurt

69437

Hopital Edouard Herriot, Lyon

71103

LSU Health Sciences Center, Feist-Weiller Cancer Center, Shreveport

75004

Hopital-DIEU, Paris

76018

Ivano-Frankivsk State Medical University, Ivano-Frankivsk

78150

Hopital de Versailles, Versailles

79044

State Institution 'Institute of Blood Pathology and Transfusion Medicine under the UAMS', Lviv

80045

University of Colorado Health Sciences Center, Aurora

80054

Hopital Sud, Amiens

80131

A.O. Cardarelli, Napoli

80218

Rocky Mountain Blood and Marrow Transplant Program, Denver

83301

Chang Gung Memorial Hospital Kao Hsiung Branch, Niao-Sung Hsiang

84103

Intermountain Healthcare, Salt Lake City

90033

Univ of Southern California Comprehensive Cancer Center, Los Angeles

90095

UCLA Medical Center, Los Angelas

91120

Hadassah Medical Center, Jerusalem

94143

University of California San Francisco, San Francisco

97239

Oregon Health & Science University, Portland

115478

State Institution Russian Oncological Research Center n.a. N.N. Blokhin of the Russian Academy of Medical Sciences, Moscow

125101

Moscow State Medical Institution Municipal, Moscow

162627

Municipal Medical Institution Municipal Hospital #1, Cherepovets

185014

State Medical Institution Republican Hospital n.a. V.A. Baranov, Petrozavodsk

194291

State Medical Institution Leningrad Regional Clinical Hospital, Saint Petersburg

197101

State Higher Educational Institution St. Petersburg State Medical University n.a. I.P. Pavlov under the Federal Agency for Healthcare and Social Development, Saint Petersburg

350040

State Medical Institution Territorial Clinical Oncological Center, Krasnodar

430031

Dr. Constantin Opris County Emergency Hospital, Internal Medicine Department, Baia Mare

500236

Brasov County Emergency Clinical Hospital, Brasov

550245

Sibiu County Clinical Hospital, Internal Clinic II, Sibiu

614010

Municipal Medical Institution, Perm

620102

State Medical Institution Sverdlovsk Regional Clinical Hospital #1, Yekaterinburg

664079

State Medical Institution Irkutsk Regional Clinical Hospital, Irkutsk

680009

State Medical Institution Territorial Clinical Hospital #1, Khabarovsk

2570017

Hospital Dr. Gustavo Fricke, Viña del Mar

7530204

Hospital Santa Maria, Santiago

7571831

Hospital DIPRECA, Santiago

02114

Dana Farber Cancer Institute, Boston

Massachusetts General Hospital, Boston

02908

Roger Williams Medical Center, Providence

B1900AXI

Hospital Italiano de La Plata, Buenos Aires

C1406FWY

"Hospital General de Agudos Dr. Teodoro Alvarez", Ciudad Autónoma de Bs. As.

C1437JCP

Clinical Hematology Service, Ciudad Autónoma de Bs. As.

Unknown

Hospital Provincial de Cordoba, Córdoba

Box Hill Hospital, Box Hill

Institute of Haematology and Blood Transfusion Prague, Prague

Instituto Ecuatoriano de Seguridad Social Hospital Regional Teodoro Maldonado Carbó, Guayaquil

Hospital Carlos Andrade Marin, Quito

Hospital Militar, Quito

University of Pecs, Pécs

State Higher Educational Instution Rostov State, Rostov-on-Don

Federal Center of Heart, Blood and Endocrinology, Saint Petersburg

Hospital Universitario La Fe, Valencia

Ukrainian Medical Academy of Dentistry, Poltava

S2000DSU

Sanatorio Parque, Rosario - Santa Fe

N6A 4L6

London Health Sciences Centre, London

B3H 2Y9

QEII Center for Clinical Research, Halifax

K1H 8L6

The Ottawa Hospital - General Campus, Ottawa

100 34

University Hospital Kralovske Vinohrady Prague, Prague

128 08

General University Hospital Prague, Prague

D-68167

Universitätsmedizin Mannheim, Mannheim

00161

"Università degli Studi di Roma La Sapienza", Roma

00144

Ospedale S. Eugenio, Rome

15-276

Teaching Hospital of the Medical University in Bialystok, Bialystok

80-952

Academic Clinical Centre - Teaching Hospital of the Medical University of Gdansk, Gdansk

93-513

Nicolaus Copernicus Provincial Specialist Hospital in Lodz, Lodz

45-372

Provincial Hospital in Opole, Opole

61-833

Poznan Stare Miasto Health Care Facility, Poznan

76-200

Janusz Korczak Provincial Specialist Hospital, Słupsk

00-909

Military Institue of Health Services, Warsaw

02-776

Institute of Hematology and Transfusiology, Warsaw

50-369

Independent Public University Hospital No. 1 in Wroclaw, Wroclaw

020125

Colentina Clinical Hospital, Internal Medicine Department, Bucharest

022328

"Fundeni Clinical Institute Stefan Berceanu Center for Hematology and Bone Marrow Transplant", Bucharest

030171

Coltea Clinical Hospital, Bucharest

614-735

Inje University Busan Paik Hospital, Busan

110-799

Seoul National University Hospital, Seoul

120-752

Severance Hospital in YUHS, Seoul

135-710

Samsung Medical Center, Seoul

138-736

Asan Medical Center, Seoul

158-710

Ewha Womans University Mokdong Hospital, Seoul

443-721

Ajou University Hospital, Suwon

08916

Hospital Germans Trias i Pujol, Badalona

08003

Hospital Del Mar, Barcelona

08035

Hospital Vall d'Hebron, Barcelona

08036

Hospital Clinic I Provinicial, Barcelona

08041

Hospital de la Santa Creu I Sant Pau, Barcelona

CF14 4XW

University Hospital of Wales, Cardiff

SE5 9RS

King's College Hospital, London

OX3 9DLJ

Churchill Hospital, Oxford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Antisoma Research

INDUSTRY

NCT00715637 - Phase III Randomized Study of Amonafide (AS1413) and Cytarabine Versus Daunorubicin and Cytarabine in Patients With Secondary Acute Myeloid Leukemia (AML)- the ACCEDE Study | Biotech Hunter | Biotech Hunter