Spots Global Cancer Trial Database for 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)
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Trial Identification
Brief Title: 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)
Official Title: An Open Label, Randomized Study of Nilotinib vs. Standard Imatinib (400/600 mg QD) Comparing the Kinetics of Complete Molecular Response for CML-CP Patients With Evidence of Persistent Leukemia by RQ-PCR.
Study ID: NCT00760877
Conditions
Study Description
Brief Summary: The primary goal of this study was to determine the rate of confirmed best cumulative complete molecular response (CMR) within the first year of study therapy with imatinib or nilotinib. The study also explored the impact and significance of the achieved CMR on patient outcomes (progression free survival (PFS), event free survival (EFS) and overall survival (OS), characterized the kinetics of CMR achieved in both treatment arms and after the cross-over.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Novartis Investigative Site, Caba, Buenos Aires, Argentina
Novartis Investigative Site, St. Leonards, New South Wales, Australia
Novartis Investigative Site, Westmead, New South Wales, Australia
Novartis Investigative Site, Herston, Queensland, Australia
Novartis Investigative Site, South Brisbane, Queensland, Australia
Novartis Investigative Site, Woolloongabba, Queensland, Australia
Novartis Investigative Site, Adelaide, South Australia, Australia
Novartis Investigative Site, Parkville, Victoria, Australia
Novartis Investigative Site, Prahran, Victoria, Australia
Novartis Investigative Site, Nedlands, Western Australia, Australia
Novartis Investigative Site, Belo Horizonte, MG, Brazil
Novartis Investigative Site, Curitiba, PR, Brazil
Novartis Investigative Site, Rio de Janeiro, RJ, Brazil
Novartis Investigative Site, Campinas, SP, Brazil
Novartis Investigative Site, Sao Paulo, SP, Brazil
Novartis Investigative Site, Vancouver, British Columbia, Canada
Novartis Investigative Site, Hamilton, Ontario, Canada
Novartis Investigative Site, Toronto, Ontario, Canada
Novartis Investigative Site, Montreal, Quebec, Canada
Novartis Investigative Site, Québec, Quebec, Canada
Novartis Investigative Site, Bordeaux, , France
Novartis Investigative Site, Creteil, , France
Novartis Investigative Site, Lyon cedex 04, , France
Novartis Investigative Site, Paris, , France
Novartis Investigative Site, Vandoeuvre les Nancy, , France
Novartis Investigative Site, Malaga, Andalucia, Spain
Novartis Investigative Site, Barcelona, Cataluña, Spain
Novartis Investigative Site, Pamplona, Navarra, Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Madrid, , Spain
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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