Trial of Decitabine in Patients With Acute Myeloid Leukemia

PHASE3CompletedINTERVENTIONAL
Enrollment

485

Participants

Timeline

Start Date

November 30, 2005

Primary Completion Date

October 31, 2009

Study Completion Date

December 31, 2010

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

Cytarabine or Supportive Care

Patient's choice with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m\^2 subcutaneously once daily for the first 10 consecutive days of each 28 day cycle, until progression or unacceptable toxicity develops. (These represent one intervention.)

DRUG

Dacogen (decitabine) only

20mg/m\^2, 1 hour intravenous (IV) for 5 consecutive days of each 28 day cycle. Cycles continue until disease progression or unacceptable toxicity develops.

Trial Locations (108)

2065

St Leonards

3002

East Melbourne

3052

Parkville

4101

South Brisbane

5700

Gyula

6000

Perth

9024

Győr

10449

Taipei

10595

Valhalla

11000

Belgrade

15232

Pittsburgh

21000

Novi Sad

27710

Durham

28006

Madrid

29406

Charleston

31008

Pamplona

32073

Orange Park

32610

Gainesville

33805

Lakeland

33901

Fort Myers

37920

Knoxville

44000

Nantes

44710

Canton

45267

Cincinnati

47804

Terre Haute

48236

Grosse Pointe Woods

49048

Kalamazoo

51101

Sioux City

53212

Glendale

57105

Sioux Falls

59037

Lille

60612

Chicago

62500

Brno

67214

Wichita

69437

Lyon

70403

Tainan City

77030

Houston

77555

Galveston

78705

Austin

93009

Bobigny

400124

Cluj-Napoca

540042

Târgu Mureş

Unknown

Los Angeles

Hollywood

Miami

Highland Park

Baton Rouge

Shreveport

Boston

Neptune City

New York

Greenville

Nashville

Temple

Eau Claire

Milwaukee

Darlinghurst

Adelaide

Rijeka

Zagreb

Zalaegerszeg

České Budějovice

Pilsen

Créteil

Limoges

Pessac

Budapest

Szeged

Szombathely

Mexico City

Gdansk

Krakow

Poznan

Warsaw

Bucharest

Arkhangelsk

Astrakhan

Barnaul

Izhevsk

Kirov

Kransnodar

Moscow

Novosibirsk

Petrozavodsk

Ryazan

Saint Petersburg

Samara

Saratov

Tyumen

Volgograd

Niš

Girona

Salamanca

Valencia

Changhua

Kaohsiung City

Sutton

01107

Springfield

AiB 3V6

St. John's

B3H 2Y9

Halifax

M4N 3M5

Toronto

128 08

Prague

93-510

Lodz

20-081

Lublin

50-367

Wroclaw

08916

Badalona-Barcelona

08035

Barcelona

07014

Palma de Mallorca

All Listed Sponsors
lead

Eisai Inc.

INDUSTRY

NCT00260832 - Trial of Decitabine in Patients With Acute Myeloid Leukemia | Biotech Hunter | Biotech Hunter