Study of Elacytarabine Versus Investigator's Choice in Patients With Late Stage Acute Myeloid Leukaemia (AML)

PHASE3CompletedINTERVENTIONAL
Enrollment

381

Participants

Timeline

Start Date

June 30, 2010

Primary Completion Date

February 28, 2013

Study Completion Date

June 30, 2013

Conditions
Acute Myeloid Leukemia (AML)
Interventions
DRUG

Elacytarabine

Elacytarabine 2000 mg/m2/d administered as a continuous intravenous infusion (CIV) in a d 1-5 q3w cycle.

DRUG

Investigator's Choice

E.g. cytarabine single agent/combinations, hypomethylating agents, best supportive care (BSC)

Trial Locations (73)

1000

Institut Jules Bordet, Brussels

1090

UZ Brussel, Brussels

2065

Royal North Shore Hopsital, Sydney

2650

University Hospital Antwerp, Edegem

3004

Alfred Hospital, Melbourne

3128

Box Hill Hospital, Melbourne

4000

CHU Liège, Liège

5021

Haukeland Universitetssykehus, Bergen

5530

UCL Mont-Godinne, Yvoir

6009

Sir Charles Gairdner Hospital, Perth

7006

St Olavs Hospital, Trondheim

8000

Algemeen Ziekenhuis Sint-Jan, Bruges

10021

New York Presbyterian Hospital, Weill-Cornell Medical College, New York

10065

Memorial Sloan-Kettering, New York

10595

New York Medical College, Valhalla

12200

Charité-Campus B. Franklin Med. Klinik Haematology, Berlin

13723

Institut J. Paoli and I. Calmettes, Marseille

15224

Western Pennsylvania Hospital, Pittsburgh

16132

A.O San Martino, Genova

18057

Universitätsklinikum Rostock, Rostock

20132

Fondazione San Raffaele del Monte Tabor, Milan

27710

Duke University Medical Center, Durham

28006

Hospital Universitario La Princesa, Madrid

29601

St. Francis Hospital, Greenville

30322

Winship Cancer Institute at Emory, Atlanta

30342

The Blood and Marrow Transplant Group of GA, Atlanta

31008

Hospital de Navarra, Pamplona

31053

CHU de Toulouse - Hôpital Purpan, Toulouse

32610

Shands at the University of Florida, Gainesville

33604

CHU de Bordeaux - Hopital Haut-Leveque, Pessac

37007

Hospital Universitario de Salamanca, Salamanca

37203

Sarah Cannon Research Institute, Nashville

40225

Heinrich-Heine Universität Düsseldorf, Klinik für Hämatologie/Onkolog. und Klin. Immunologie, Düsseldorf

45236

The Jewish Hospital, Cincinnati

46009

Hospital Universitario La Fé, Servicio de Hematología, Valencia

46107

St. Francis Hospital and Health Center, Indianapolis

48121

Hospital S. Maria delle Croci, Ravenna

48149

Universitätsklinikum Münster, Medisinische Klinik & Poliklinik A, Münster

50134

A.O.U Careggi, Florence

52242

University of Iowa Hopsitals, Iowa City

53226

Froedtert Hospital, Medical College of Wisconsin, Milwaukee

55131

III. Medizinische Klinik und Poliklinik;Hämatologie, Onkologie und Pneumologie, Mainz

60611

Northwestern University, Chicago

60612

Rush University Medical Center, Chicago

69437

Hopital Edouard Herriot, Lyon

70736

Robert-Bosch-Krankenhaus, Abt.Hämatologie,Onkologie u.Palliativmedizin, Stuttgart

71103

LSU Health Sciences Center,, Shreveport

75271

Hopital Saint Antoine, Paris

80131

A.O. Cardarelli, Napoli

80218

Rocky Mountain Blood and Bone Marrow Transplant Program, Denver

87042

CHU Limoges - Hôpital Dupuytren, Limoges

89081

Universitätsklinikum Ulm, Klinik für Innere Medizin III, Comprehensive Cancer Center Ulm (CCCU), Ulm

90033

USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles

90095

Scripps Cancer Center Clinical Research, La Jolla

UCLA School of Medicine, Division of Hematology/Oncology, Los Angeles

400124

"Oncology Institute ,,Ion Chiricuta Cluj Napoca , Hematology dept.", Cluj-Napoca

700111

"St. Spiridon University Hospital, Hematology Department", Iași

07601

Northern New Jersey Cancer Associates, Hackensack

27157-1082

Wake Forest University, Health Sciences Section on Hematology and Oncology, Winston-Salem

M5G2M9

Princess Margaret Hospital, Toronto

06189

Centre Antoine Lacassagne, Nice

Unknown

Evangelische Kliniken Johanniter- und Waldkrankenhaus Bonn GmbH, Bonn

St James's Hospital Dublin, Dublin

University Hospital Galway, Galway

00133

Fondazion Policlin T Vergata, Roma

0027

Oslo University Hospital, Oslo

50-367

Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu, Wroclaw

022328

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

08916

Hospital Germans Trias i Pujol, Badalona

07014

Hospital Universitari Son Dureta, Palma de Mallorca

G12 0YN

Gartnavel General Hospital: Beatson WOS Cancer Centre, Glasgow

BS2 8ED

Bristol Haematology and Oncology Centre, Bristol

M20 4BX

Christie Hospital, Haematology and Transplant Day Unit, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Clavis Pharma

INDUSTRY