An Exploratory Trial to Assess the Improvement of Adverse Events in Chronic Myelogenous Leukemia Patients Treated With Imatinib When Switched to Nilotinib Treatment
NCT ID: NCT00980018
Last Updated: 2021-07-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
52 participants
INTERVENTIONAL
2009-12-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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nilotinib
Participants received two 150 \[a total of 300 mg at each dosing\] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules \[a total of 400 mg at each dosing\] for patients enrolled prior to Protocol Amendment 1).
Nilotinib
Participants received two 150 \[a total of 300 mg at each dosing\] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules \[a total of 400 mg at each dosing\] for patients enrolled prior to Protocol Amendment 1).
Interventions
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Nilotinib
Participants received two 150 \[a total of 300 mg at each dosing\] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules \[a total of 400 mg at each dosing\] for patients enrolled prior to Protocol Amendment 1).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2
3. Diagnosis of CML-CP associated with Bcr-Abl quantifiable by RQ-PCR (IS)
4. Patients must be an imatinib responder and achieved the following efficacy milestones as appropriate for the length of time on imatinib therapy as per protocol
5. CML-CP patients initiated on any dose of imatinib
6. Ability to provide written informed consent prior to any study related screening procedures being done
Exclusion Criteria
2. Prior accelerated phase or blast phase CML
3. Previously documented T315I mutation
4. Presence of chromosomal abnormalities (trisomy 8) and/or clonal evolution other than Ph+.
5. Previous treatment with any other tyrosine kinase inhibitor except for imatinib.
6. Treatment with other investigational agents within 30 days of Day 1.
7. History of non-compliance to medical regimens or inability to grant consent.
8. Women who are pregnant, breast feeding, or of childbearing potential without a negative serum test at baseline. Male or female patients of childbearing potential unwilling to use contraceptive precautions throughout the trial and 3 months following discontinuation of study drug. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Women of childbearing potential must have a negative serum pregnancy test prior to the first dose of nilotinib.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Highlands Oncology Group
Fayetteville, Arkansas, United States
Hematology Oncology Services of Arkansas SC
Little Rock, Arkansas, United States
USC Norris Cancer Center LAC & USC Medical Center
Los Angeles, California, United States
Southwest Cancer Care Murrieta
Poway, California, United States
Rocky Mountain Cancer Centers RMCC - Aurora
Greenwood Village, Colorado, United States
Florida Cancer Institute
New Port Richey, Florida, United States
Cancer Centers of Florida PA Cancer Centers of FL-Orlando-4
Ocoee, Florida, United States
Stroger Cook County Hospital John H. Stroger Hospital
Chicago, Illinois, United States
St. Francis Hospital and Health Centers IndianaBlood&MarrowTransplantn
Beech Grove, Indiana, United States
St. Agnes Hospital
Baltimore, Maryland, United States
St. Louis University Cancer Center
St Louis, Missouri, United States
Northwest Cancer Specialists Salmon Creek Office
Portland, Oregon, United States
Oregon Health Sciences University
Portland, Oregon, United States
The Jones Clinic
Germantown, Tennessee, United States
Texas Oncology, P.A.
Bedford, Texas, United States
Presbyterian Hospital of Dallas TexasOncology@PresbyterianHosp
Dallas, Texas, United States
Texas Oncology Texas Oncology - Sugar Land
Dallas, Texas, United States
MD Anderson Cancer Center/University of Texas
Houston, Texas, United States
Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2)
San Antonio, Texas, United States
Novartis Investigative Site
Brampton, Ontario, Canada
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Countries
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References
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Cortes JE, Lipton JH, Miller CB, Busque L, Akard LP, Pinilla-Ibarz J, Keir C, Warsi G, Lin FP, Mauro MJ. Evaluating the Impact of a Switch to Nilotinib on Imatinib-Related Chronic Low-Grade Adverse Events in Patients With CML-CP: The ENRICH Study. Clin Lymphoma Myeloma Leuk. 2016 May;16(5):286-96. doi: 10.1016/j.clml.2016.02.002. Epub 2016 Feb 16.
Related Links
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Related Info
Other Identifiers
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CAMN107AUS17
Identifier Type: -
Identifier Source: org_study_id
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