A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
Public ClinicalTrials.gov record NCT00471497. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III Multi-center, Open-label, Randomized Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
In this study, the efficacy and safety of two nilotinib doses, 300 mg twice daily and 400 mg twice daily, were 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). An extension protocol was included in this study design to allow patients who did not show sufficient response to their assigned treatments the opportunity to receive imatinib 400 mg BID (option available until protocol amendment 7) or nilotinib 400 mg BID, using an abbreviated safety and efficacy assessment schedule.
Study identification
- NCT ID
- NCT00471497
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 846 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2007 (Actual)
- Primary completion
- Sep 2, 2009 (Actual)
- Completion
- Aug 21, 2019 (Actual)
- Last update posted
- Nov 18, 2020
2007 – 2019
United States locations
- U.S. sites
- 31
- U.S. states
- 19
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California at Los Angeles Dept. of Hematology Clinic | Los Angeles | California | 90095 | — |
| Kaiser Permanente - California Southern Dept of Kaiser South 3 | San Diego | California | 92120 | — |
| Kaiser Permanente - California Northern Vallejo Med Center/Med Offices | Vallejo | California | 94589 | — |
| Kaiser Permanente - California Northern Kaiser Med | Vallejo | California | 94609 | — |
| Rocky Mountain Cancer Centers RMCC - Colorado Springs | Greenwood Village | Colorado | — | — |
| Florida Cancer Specialists Dept. FloridaCancerSpecialists | Fort Myers | Florida | 33901 | — |
| Advanced Medical Specialties Research Dept. | Miami | Florida | 33176 | — |
| Cancer Centers of Florida PA Cancer Centers of FL | Ocoee | Florida | 34761 | — |
| Florida Retina Institute Flordia Cancer Affilates | Orlando | Florida | 32804 | — |
| University of Chicago Section of Hematology/Oncology | Chicago | Illinois | 60637 | — |
| Indiana Blood and Marrow Institute Dept. of Indiana Blood&Marrow | Beech Grove | Indiana | 46107 | — |
| University of Iowa Hospitals and Clinics Dept.of U of Iowa Hosp&Clinics | Iowa City | Iowa | 52242 | — |
| Kansas City Cancer Center KCCC Business Office | Overland Park | Kansas | 66210 | — |
| LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center | New Orleans | Louisiana | 70115 | — |
| Michigan State University / Breslin Cancer Center Breslin Cancer Center | Lansing | Michigan | 48824 | — |
| Missouri Cancer Associates Dept. of Boone Hospital Center | Columbia | Missouri | 65201 | — |
| Hematology Oncology Consultants, Inc. Deptof Hem. Onc.Consunsultants | St Louis | Missouri | 63136 | — |
| Hackensack University Medical Center Department of Research | Hackensack | New Jersey | 07601 | — |
| Memorial Sloan Kettering Cancer Center Clinical Trials Office | New York | New York | 10021 | — |
| University of North Carolina UNC Lineberger Cancer Center | Chapel Hill | North Carolina | 27514 | — |
| Wake Forest University Health Sciences Dept. of Industry Research | Winston-Salem | North Carolina | 27157 | — |
| University of Cincinnati / Barrett Cancer Center Dept.of Internal Med. | Cincinnati | Ohio | 45219 | — |
| Cleveland Clinic Foundation CCF | Cleveland | Ohio | 44195 | — |
| Northwest Cancer Specialists Compass Oncology -BKM | Portland | Oregon | 97210 | — |
| Cancer Centers of the Carolinas CC of C -Eastside | Greenville | South Carolina | 29605 | — |
| Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology | Chattanooga | Tennessee | 37404 | — |
| Tennessee Oncology Dept. of Centennial Medical | Nashville | Tennessee | 37203 | — |
| Texas Cancer Center ( Medical City Dallas Hospital) | Dallas | Texas | 75230 | — |
| Cancer Care Centers of South Texas HOAST CCC of So.TX- Medical Center | San Antonio | Texas | 78229 | — |
| Tyler Cancer Center | Tyler | Texas | 75702 | — |
| Utah Cancer Specialists | Salt Lake City | Utah | 84106 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 182 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00471497, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 18, 2020 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00471497 live on ClinicalTrials.gov.