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Study of Molecular Response in Adult Patients on Nilotinib With Philadelphia Chromosome Positive Chronic Myelogenous Leukemia (Ph+ CML) in Chronic Phase and a Suboptimal Molecular Response to Imatinib
Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
Basic Trial Information
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Protocol IDs
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Phase II
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Biomarker/Laboratory analysis, Treatment
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Active
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18 and over
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Pharmaceutical / Industry
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CAMN107AUS09
NCT00644878
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Trial Description
Summary This exploratory study will evaluate the change in molecular response in chronic myelogenous leukemia - chronic phase patients with a complete cytogenetic response and have a suboptimal molecular response to imatinib Eligibility Criteria Inclusion Criteria: - Evidence of CML-CP and CCyR
- Treatment with 1-6 years of imatinib, but a reduction of Bcr-Abl transcript levels to ≤ 0.1% on the international scale has not been achieved
- Treatment with < 6 years of imatinib and a greater than 1 log increase in Bcr-Abl transcript levels is observed
- Greater than or equal to 18 ears of age
Exclusion Criteria: - Previous diagnosis of CML-accelerated phase (AP) or blast crisis (BC)
- Treatment with any other tyrosine kinase inhibitor except for imatinib
- Significant cardiovascular disease
- Use of certain medications prohibited by the protocol
- Use of medications that prolong QT interval
- Major surgery within 4 weeks
- Treatment with other investigational agents within 30 days Other protocol-defined inclusion/exclusion criteria may apply
Trial Contact Information
Trial Lead Organizations/Sponsors Novartis Pharmaceuticals Corporation | Novartis | | Ph: 800 340 6843 |
Trial Sites
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| U.S.A. |
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| Colorado |
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Fort Collins |
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| | | | | | | | | Front Range Cancer Specialists |
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Ph: 970-212-7609 |
| | | Robert Marschke, M.D. | Principal Investigator |
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| Florida |
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Leesburg |
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| | | | Cancer Center of Central Florida |
| | | Sharon Hiemenz |
Ph: 352-787-3341 |
| | | John Hiemenz, M.D. | Principal Investigator |
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Miami |
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| | | Innovative Medical Research of South Florida, Incorporated |
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Ph: 305-759-1881 |
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Email:
immed1@aol.com |
| | | Marc Saltzman, M.D. | Principal Investigator |
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| Georgia |
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Augusta |
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| | | | Medical College of Georgia Cancer Center |
| | | Robin Dobbins |
Ph: 706-721-2388 |
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Email:
rdobbins@mcg.edu |
| | | Anand P. Jillella | Principal Investigator |
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| Indiana |
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Beech Grove |
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| | | | Indiana Blood and Marrow Transplantation |
| | | Kay Harvey |
Ph: 317-782-6254 |
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Email:
kharvey@ibmtindy.com |
| | | Luke Paul Akard | Principal Investigator |
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| Iowa |
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Sioux City |
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| | | | Siouxland Hematology-Oncology Associates, LLP |
| | | Susan Lucken |
Ph: 712-252-9408 |
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Email:
luckens@shoa-research.org |
| | | Stephen P. Kahanic | Principal Investigator |
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| Maryland |
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Baltimore |
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| | | | St. Agnes Hospital Cancer Center |
| | | Elizabeth Chandler |
Ph: 410-368-2966 |
| | | Imene Benayche |
Ph: 410-368-2966 |
| | | Carole Miller | Principal Investigator |
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| New Jersey |
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Hackensack |
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| | | | Hackensack University Medical Center Cancer Center |
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Ph: 201-996-5234 |
| | | Stuart Goldberg, MD | Principal Investigator |
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| Oklahoma |
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Lawton |
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| | | | Cleo Craig Memorial Center |
| | | Suzie McCoy |
Ph: 580-536-2121 |
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Email:
sem.cleocraig@sbcglobal.net |
| | | Nadim Nimeh, M.D. | Principal Investigator |
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| South Carolina |
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Greenville |
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| | | | Cancer Centers of the Carolinas - Eastside |
| | | Gina Norris |
Ph: 864-242-2762 |
| | | Joe J. Stephenson | Principal Investigator |
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| Utah |
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Provo |
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| | | | Central Utah Clinic |
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Ph: 801-812-5022 |
| | | Brian Tudor, M.D. | Principal Investigator |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00644878
Information obtained from ClinicalTrials.gov on September 22, 2008 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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