Nilotinib Versus Standard Imatinib (400/600 mg Every Day (QD)) Comparing the Kinetics of Complete Molecular Response for Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Pts With Evidence of Persistent Leukemia by Real-time Quantitative Polymerase Chain Reaction (RQ-PCR)

PHASE3CompletedINTERVENTIONAL
Enrollment

207

Participants

Timeline

Start Date

June 30, 2009

Primary Completion Date

July 31, 2015

Study Completion Date

July 31, 2015

Conditions
CHRONIC MYELOGENOUS LEUKEMIA
Interventions
DRUG

Nilotinib

Supplied in 200 mg capsules

DRUG

Imatinib

Supplied in 100 mg and 400 mg capsules

Trial Locations (30)

2065

Novartis Investigative Site, St Leonards

2145

Novartis Investigative Site, Westmead

3050

Novartis Investigative Site, Parkville

3181

Novartis Investigative Site, Prahran

4029

Novartis Investigative Site, Herston

4101

Novartis Investigative Site, South Brisbane

4102

Novartis Investigative Site, Woolloongabba

5000

Novartis Investigative Site, Adelaide

6009

Novartis Investigative Site, Nedlands

28006

Novartis Investigative Site, Madrid

28007

Novartis Investigative Site, Madrid

29010

Novartis Investigative Site, Málaga

31008

Novartis Investigative Site, Pamplona

33076

Novartis Investigative Site, Bordeaux

54511

Novartis Investigative Site, Vandœuvre-lès-Nancy

69317

Novartis Investigative Site, Lyon

75010

Novartis Investigative Site, Paris

94010

Novartis Investigative Site, Créteil

C1221ADH

Novartis Investigative Site, Caba

30130-100

Novartis Investigative Site, Belo Horizonte

80060-900

Novartis Investigative Site, Curitiba

21941-913

Novartis Investigative Site, Rio de Janeiro

13083-970

Novartis Investigative Site, Campinas

05403-000

Novartis Investigative Site, São Paulo

V5Z 1M9

Novartis Investigative Site, Vancouver

L8H 4J9

Novartis Investigative Site, Hamilton

M5G 2M9

Novartis Investigative Site, Toronto

H1T 2M4

Novartis Investigative Site, Montreal

G1J 1Z4

Novartis Investigative Site, Québec

08036

Novartis Investigative Site, Barcelona

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY