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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00760877 |
The primary goal of this study is to determine the rate of confirmed best cumulative complete molecular response within the first year of study therapy with imatinib or nilotinib. The study will also explore the impact and significance of the achieved CMR on patient outcomes (PFS, EFS and OS), characterize the kinetics of CMR achieved in both treatment arms and after the cross-over.
Condition | Intervention | Phase |
---|---|---|
Chronic Myelogenous Leukemia |
Drug: Nilotinib Drug: Imatinib |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 192 |
Study Start Date: | November 2008 |
Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Nilotinib
400 mg BID
|
2: Active Comparator |
Drug: Imatinib
400 mg QD or 600 mg QD
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Impaired cardiac function including any one of the following:
Contact: Novartis | 862-778-8300 | |
Contact: Novartis | +41 61 324 1111 |
Australia | |
Novartis Investigative Site | |
Westmead, Australia | |
Novartis Investigative site | |
Herston, Australia | |
Novartis Investigative Site | |
South Brisbane, Australia | |
Novartis Investigative Site | |
Nedlands, Australia | |
Novartis Investigative Site | |
Parkville, Australia | |
Novartis Investigative Site | |
Melbourne, Australia | |
Novartis Investigative Site | |
Adelaide, Australia | |
Brazil | |
Novartis Investigative Site | |
Sao Paulo, Brazil | |
Novartis Investigative Site | |
Rio de Janeiro, Brazil | |
Novartis Investigative Site | |
Curitiba, Brazil | |
Canada | |
Novartis Investigative Site | |
Ottawa, Canada | |
Novartis Investigative Site | |
Hamilton, Canada | |
Novartis Investigative Site | |
Halifax, Canada | |
Novartis Investigative Site | |
Sherbrooke, Canada | |
Novartis Investigative Site | |
Montreal, Canada |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CAMN107A2405 |
Study First Received: | September 25, 2008 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00760877 |
Health Authority: | United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration; Brazil: Ministry of Health; Canada: Health Canada |
CHRONIC MYELOGENOUS LEUKEMIA Chronic Phase CML |
Imatinib Leukemia Chronic myelogenous leukemia Hematologic Diseases |
Myeloproliferative Disorders Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Bone Marrow Diseases |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |