NCT01890746 - A Safety and Efficacy Study of Eltrombopag in Subjects With AML | Biotech Hunter

Enrollment

148

Participants

Timeline

Start Date

September 5, 2013

Primary Completion Date

March 13, 2015

Study Completion Date

January 25, 2017

Conditions

Acute Leukaemia

Interventions

DRUG

Daunorubicin

For subjects between the ages of 18 and 60 years, 90 mg/m2/day by bolus IV injection through a freshly established free-flowing IV line for 10-15 minutes on days 1, 2, and 3. For subjects \> 60 years: daunorubicin dose was adjusted to 60mg /m2.

DRUG

Cytarabine

100 mg/m2/day continuous IV infusion on Days 1 through 7.

DRUG

Eltrombopag

200 mg orally, once daily, beginning on Day 4 of the first cycle of induction. After 7 days, the dose of the Investigational Product (IP) was to be increased to 300 mg if platelet counts were \<100 Gi/L. IP continued until achievement of platelet count of at least 200 Gi/L or assessment of remission of bone marrow status or a maximum of 42 days after initiation of most recent induction. In subjects of East Asian heritage 100 mg orally once daily (a 50% dose reduction) was used and after 7 days, the dose of IP was increased to 150 mg if platelet counts were \<100 Gi/L.

DRUG

Placebo

Orally, once daily, beginning on Day 4 of the first cycle of induction. After 7 days, the dose given was matching 300 mg Eltrombopag if platelet counts were \<100 Gi/L. Placebo continued until achievement of platelet count of at least 200 Gi/L or assessment of remission of bone marrow status or a maximum of 42 days after initiation of most recent induction. In subjects of East Asian heritage placebo matching 100 mg Eltrombopag orally once daily was used and after 7 days, the placebo matching 150 mg Eltrombopag was given if platelet counts were \<100 Gi/L.

Trial Locations (42)

1070

Novartis Investigative Site, Brussels

2217

Novartis Investigative Site, Kogarah

3000

Novartis Investigative Site, Leuven

3004

Novartis Investigative Site, Melbourne

3050

Novartis Investigative Site, Parkville

4012

Novartis Investigative Site, Debrecen

6720

Novartis Investigative Site, Szeged

11527

Novartis Investigative Site, Athens

14642

Novartis Investigative Site, Rochester

19104

Novartis Investigative Site, Philadelphia

22713

Novartis Investigative Site, Durham

26500

Novartis Investigative Site, Pátrai

30322

Novartis Investigative Site, Atlanta

31096

Novartis Investigative Site, Haifa

32806

Novartis Investigative Site, Orlando

33136

Novartis Investigative Site, Miami

37232

Novartis Investigative Site, Nashville

44281

Novartis Investigative Site, Kfar Saba

44710

Novartis Investigative Site, Canton

50010

Novartis Investigative Site, Ames

58100

Novartis Investigative Site, Holon

64128

Novartis Investigative Site, Kansas City

64239

Novartis Investigative Site, Tel Aviv

91031

Novartis Investigative Site, Jerusalem

91120

Novartis Investigative Site, Jerusalem

115478

Novartis Investigative Site, Moscow

197341

Novartis Investigative Site, St'Petersburg

248007

Novartis Investigative Site, Kaluga

300053

Novartis Investigative Site, Tula

440071

Novartis Investigative Site, Penza

603126

Novartis Investigative Site, Nizhny Novgorod

06030-1628

Novartis Investigative Site, Farmington

51101-1733

Novartis Investigative Site, Sioux City

01805

Novartis Investigative Site, Burlington

02903

Novartis Investigative Site, Providence

M5G 2M9

Novartis Investigative Site, Toronto

H2L 4M1

Novartis Investigative Site, Montreal

76-200

Novartis Investigative Site, Słupsk

50-367

Novartis Investigative Site, Wroclaw

135-710

Novartis Investigative Site, Seoul

138-736

Novartis Investigative Site, Seoul

137-701

Novartis Investigative Site, Seoul, Korea