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A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
Basic Trial Information
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Phase
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Type
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Status
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Age
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Sponsor
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Protocol IDs
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Phase III
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Treatment
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Active
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18 and over
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Pharmaceutical / Industry
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CAMN107A2303
NCT00471497
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Trial Description
Summary In this study, the efficacy and safety of two nilotinib doses, 300 mg twice daily and 400 mg twice daily, will be compared with imatinib 400 mg once daily in newly diagnosed patients with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP). Eligibility Criteria Inclusion criteria - Chronic myelogenous leukemia in chronic phase patients within the first 6 months of diagnosis.
- Diagnosis of chronic myelogenous leukemia in chronic phase with confirmation of Philadelphia chromosome
Exclusion criteria - Treatment with a tyrosine kinase inhibitor prior to study entry is not allowed except for no more than 2 weeks in duration of imatinib
- Any medical treatment for CML prior to study entry for longer than 2 weeks with the exception of hydroxyurea and/or anagrelide
- Uncontrolled or significant cardiovascular disease.
- Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection).
- Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon)
- Currently taking certain medications that could affect the rhythm of your heart.
Other protocol-defined inclusion/exclusion criteria may apply
Trial Contact Information
Trial Lead Organizations/Sponsors Novartis Pharmaceuticals Corporation | Novartis | | Study Chair |
| Novartis U.S. | | Ph: 862 778 8300 |
| Novartis Basel | | Ph: 41 61 324 1111 |
Trial Sites
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| U.S.A. |
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| California |
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Anaheim |
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| | | | | | | | | Southern Permanente Medical Group |
| | | Subramanyam Rau, M.D. |
Ph: 619-641-4527 |
| | | Subramanyam Rau, M.D. | Principal Investigator |
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Baldwin Park |
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| | | Southern California Permanente Medical Group |
| | | John Liang, M.D. |
Ph: 619-641-4527 |
| | | John Liang, M.D. | Principal Investigator |
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Fontana |
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| | | Southern Permanente Medical Group |
| | | Sohail Saeed, M.D. |
Ph: 619-641-4527 |
| | | Sohail Saeed, M.D. | Principal Investigator |
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Hayward |
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| | | Hayward Medical Center |
| | | Lou Fehrenbacher, M.D. |
Ph: 510-784-6070 |
| | | Lou Fehrenbacher, M.D. | Principal Investigator |
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Los Angeles |
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| | | Kaiser Permanente Medical Center - Los Angeles |
| | | Michael Glowalla, M.D. |
Ph: 619-641-4527 |
| | | Michael Glowalla, M.D. | Principal Investigator |
| | | Eric McGary, M.D. |
Ph: 619-641-4527 |
| | | Eric McGary, M.D. | Principal Investigator |
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Oakland |
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| | | Kaiser Permanente Medical Center - Oakland |
| | | Lou Fehrenbacher, M.D. |
Ph: 510-752-7495 |
| | | Lou Fehrenbacher, M.D. | Principal Investigator |
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Panorama City |
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| | | Kaiser Permanente Medical Group |
| | | Swarminathan Ramanathan, M.D. |
Ph: 619-641-4527 |
| | | Swarminathan Ramanathan, M.D. | Principal Investigator |
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Riverside |
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| | | Kaiser Permanente Medical Center - Riverside |
| | | Fawaz Gailani, M.D. |
Ph: 619-641-4527 |
| | | Fawaz Gailani, M.D. | Principal Investigator |
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Sacramento |
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| | | Kaiser Permanente Medical Center - Sacramento |
| | | Lou Fehrenbacher, M.D. |
Ph: 916-973-5840 |
| | | Lou Fehrenbacher, M.D. | Principal Investigator |
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San Diego |
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| | | Southern California Permanente Medical Group |
| | | Han Koh, M.D. |
Ph: 619-641-4527 |
| | | Han Koh, M.D. | Principal Investigator |
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San Francisco |
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| | | Kaiser Permanente Medical Center - San Francisco Geary Campus |
| | | Lou Fehrenbacher, M.D. |
Ph: 415-833-2495 |
| | | Lou Fehrenbacher, M.D. | Principal Investigator |
| | | South San Francisco Medical Center |
| | | Lou Fehrenbacher, M.D. |
Ph: 650-742-3939 |
| | | Lou Fehrenbacher, M.D. | Principal Investigator |
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San Jose |
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| | | Two North |
| | | Lou Fehrenbacher, M.D. |
Ph: 408-972-6037 |
| | | Lou Fehrenbacher, M.D. | Principal Investigator |
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Santa Clara |
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| | | Dept. of Santa Clara Medical Office |
| | | Lou Fehrenbacher, M.D. |
Ph: 408-851-4314 |
| | | Lou Fehrenbacher, M.D. | Principal Investigator |
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Vallejo |
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| | | Kaiser Permanente Medical Center - Vallejo |
| | | Lou Fehrenbacher, M.D. |
Ph: 707-651-2786 |
| | | Lou Fehrenbacher, M.D. | Principal Investigator |
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Walnut Creek |
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| | | Walnut Creek Medical Center |
| | | Lou Fehrenbacher, M.D. |
Ph: 925-295-5372 |
| | | Lou Fehrenbacher, M.D. | Principal Investigator |
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Woodland Hills |
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| | | Southern California Permanente Medical Group |
| | | Erik Jancis, M.D. |
Ph: 619-641-4527 |
| | | Erik Jancis, M.D. | Principal Investigator |
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| Colorado |
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Denver |
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| | | | Rocky Mountain Cancer Centers - Colorado Springs |
| | | John Burke, M.D. |
Ph: 303-285-5011 |
| | | John Burke, M.D. | Principal Investigator |
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| Florida |
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Ft. Myers |
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| | | | Florida Cancer Specialists - Fort Myers Broadway |
| | | Thomas Ervin, M.D. |
Ph: 615-986-7274 |
| | | Thomas Ervin, M.D. | Principal Investigator |
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New Port Richey |
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| | | Florida Cancer Institute - New Port Richey |
| | | Gerald Robbins, M.D. |
Ph: 727-843-9841 |
| | | Gerald Robbins, M.D. | Principal Investigator |
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| Georgia |
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Marietta |
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| | | | Northwest Georgia Oncology Centers, PC - Marietta Center |
| | | Mary Gilley |
Ph: 770-281-5131 |
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Email:
mgilley@ngoc.com |
| | | Robert C. Hermann | Principal Investigator |
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| Illinois |
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Chicago |
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| | | | John H. Stroger Hospital of Cook County |
| | | Rose Catchatourian, M.D. |
Ph: 312-864-7263 |
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Email:
rcatchator@ccbhs.org |
| | | Rose Catchatourian, M.D. | Principal Investigator |
| | | Robert H. Lurie Comprehensive Cancer Center at Northwestern University |
| | | Martin Tallman, M.D. |
Ph: 312-695-1383 |
| | | Martin Tallman, M.D. | Principal Investigator |
| | | University of Chicago Cancer Research Center |
| | | Richard Larson, M.D. |
Ph: 773-834-0730 |
| | | Richard A. Larson | Principal Investigator |
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| Indiana |
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Beech Grove |
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| | | | Indiana Blood and Marrow Transplantation |
| | | Jean Lonergan |
Ph: 317-782-7298 |
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Email:
jlonergan@ibmtindy.com |
| | | Luke Paul Akard | Principal Investigator |
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Indianapolis |
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| | | Central Indiana Cancer Centers - South |
| | | David Loesch, M.D. |
Ph: 317-964-5200 |
| | | David Loesch, M.D. | Principal Investigator |
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| Kansas |
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Overland Park |
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| | | | Kansas City Cancer Centers - Southwest |
| | | John Davis, M.D. |
Ph: 913-234-0400 |
| | | John Davis, M.D. | Principal Investigator |
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| Michigan |
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Lansing |
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| | | | Breslin Cancer Center |
| | | Anas Al-Janadi, M.D. |
Ph: 517-334-2765 |
| | | Anas Al-Janadi, M.D. | Principal Investigator |
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Southfield |
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| | | Newland Medical Associates PC - Southfield |
| | | Howard Terebelo, M.D. |
Ph: 248-552-0620 |
| | | Howard Terebelo, M.D. | Principal Investigator |
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| Minnesota |
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Minneapolis |
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| | | | Minnesota Oncology Hematology, PA - Minneapolis |
| | | Patrick Flynn, M.D. | |
| | | Patrick Flynn, M.D. | Principal Investigator |
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| Missouri |
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Columbia |
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| | | | Missouri Cancer Associates |
| | | David Schlossman, M.D. |
Ph: 573-817-8538 |
| | | David Schlossman, M.D. | Principal Investigator |
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St. Joseph |
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| | | Saint Joseph Oncology, Incorporated |
| | | Rowny Abou-Jawde, M.D. |
Ph: 816-271-1032 |
| | | Rony Abou-Jawde, M.D. | Principal Investigator |
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St. Louis |
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| | | Hematology Oncology Consultants, Incorporated |
| | | Mark Woodson, M.D. |
Ph: 314-355-5597 Ext.31 |
| | | Mark Woodson, M.D. | Sub-Investigator |
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| New Jersey |
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Hackensack |
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| | | | Hackensack University Medical Center Cancer Center |
| | | Stuart Goldman, M.D. |
Ph: 201-336-8598 |
| | | Stuart L. Goldberg | Principal Investigator |
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| New York |
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New York |
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| | | | Memorial Sloan-Kettering Cancer Center |
| | | Mark Heaney, M.D. |
Ph: 646-227-2173 |
| | | Mark Heaney, M.D. | Principal Investigator |
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| North Carolina |
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Chapel Hill |
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| | | | University of North Carolina at Chapel Hill/UNC Lineberger Cancer Center |
| | | Thomas Shea, M.D. |
Ph: 919-966-4432 |
| | | Thomas Shea, M.D. | Principal Investigator |
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Durham |
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| | | Duke Comprehensive Cancer Center |
| | | Joseph Moore, M.D. |
Ph: 919-681-4769 |
| | | Joseph Moore, M.D. | Principal Investigator |
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Raleigh |
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| | | Cancer Centers of North Carolina - Raleigh |
| | | William Berry, M.D. |
Ph: 919-854-6950 |
| | | William Berry, M.D. | Principal Investigator |
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Winston-Salem |
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| | | Wake Forest University Comprehensive Cancer Center |
| | | Bayard Powell, M.D. |
Ph: 336-713-3539 |
| | | Bayard L. Powell | Principal Investigator |
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| Ohio |
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Cincinnati |
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| | | | Oncology Hematology Care |
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Cleveland |
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| | | Case Comprehensive Cancer Center |
| | | Mary Laughlin, M.D. |
Ph: 216-844-8123 |
| | | Mary Laughlin, M.D. | Principal Investigator |
| | | Cleveland Clinic Taussig Cancer Center |
| | | Matt Kalaycio, M.D. |
Ph: 216-444-0744 |
| | | Matt Kalaycio, M.D. | Principal Investigator |
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| South Carolina |
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Greenville |
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| | | | Hematology and Oncology Associates of S.C. |
| | | William Edenfield, M.D. |
Ph: 864-242-2722 |
| | | William Edenfield, M.D. | Principal Investigator |
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| Tennessee |
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Chattanooga |
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| | | | Chattanooga Oncology and Hematology Associates |
| | | Edward Arrowsmith, M.D. |
Ph: 423-698-1844 |
| | | Edward Arrowsmith, M.D. | Principal Investigator |
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Germantown |
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| | | Jones Cancer Center |
| | | C. Michael Jones, M.D. |
Ph: 901-685-5969 |
| | | C. Michael Jones | Principal Investigator |
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Nashville |
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| | | Tennessee Oncology, PLLC -
Baptist Medical Building |
| | | Ian Flinn, M.D. |
Ph: 615-329-7252 |
| | | Ian Flinn, M.D. | Principal Investigator |
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| Texas |
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Dallas |
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| | | | Charles A. Sammons Cancer Center |
| | | Marnie Fischer |
Ph: 214-370-1038 |
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Email:
Marnie.Fisher@USONCOLOGY.COM |
| | | Karen Courtney | |
| | | Barry Coper, M.D. | Principal Investigator |
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Houston |
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| | | M. D. Anderson Cancer Center at University of Texas |
| | | Jorge Cortes, M.D. |
Ph: 713-792-6408 |
| | | Jorge Cortes | Principal Investigator |
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Odessa |
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| | | Texas Oncology, PA |
| | | Pankaj Khandelwal, M.D. |
Ph: 432-335-8275 |
| | | Pankaj Khandelwal, M.D. | Principal Investigator |
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San Antonio |
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| | | Cancer Care Centers of South Texas - Medical Center |
| | | Gregory Guzley, M.D. |
Ph: 210-595-5300 |
| | | Gregory Guzley, M.D. | Principal Investigator |
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Tyler |
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| | | Tyler Cancer Center |
| | | Donald Richards, M.D. |
Ph: 903-579-9800 |
| | | Donald A. Richards | Principal Investigator |
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| Utah |
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Salt Lake City |
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| | | | Utah Cancer Specialists |
| | | W. Graydon Harker, M.D. |
Ph: 801-281-6864 |
| | | W. Graydon Harker, M.D. | Principal Investigator |
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| Virginia |
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Charlottesville |
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| | | | University of Virginia Cancer Center |
| | | Michael Douvas, M.D. |
Ph: 434-924-5254 |
| | | Martin Douvas, M.D. | Principal Investigator |
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| Washington |
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Spokane |
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| | | | San Antonio Tumor and Blood Clinic - Madison Oaks |
| | | Robert Gersh, M.D. |
Ph: 509-228-1226 |
| | | Robert Gersh, M.D. | Principal Investigator |
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Vancouver |
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| | | Northwest Cancer Specialists at Vancouver Cancer Center |
| | | Katherine Kolibaba, M.D. |
Ph: 360-573-0471 |
| | | Katherine Kolibaba, M.D. | Principal Investigator |
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| United Kingdom |
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Glasgow |
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| | | | Novartis Investigative Site |
| | | Tessa Holyoake, Prof | Principal Investigator |
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Leeds |
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| | | Novartis Investigative Site |
| | | Graeme Smith, M.D. | Principal Investigator |
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Liverpool |
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| | | Novartis Investigative Site |
| | | Richard Clark, Prof | Principal Investigator |
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London |
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| | | Novartis Investigative Site |
| | | David Marin, M.D. | Principal Investigator |
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Nottingham |
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| | | Novartis Investigative Site |
| | | Jenny Byrne, M.D. | Principal Investigator |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00471497
Information obtained from ClinicalTrials.gov on October 06, 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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