A Study That Switched Patients From Imatinib to Nilotinib and Then Was Followed by Treatment Cessation
NCT ID: NCT01744665
Last Updated: 2020-03-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
59 participants
INTERVENTIONAL
2013-08-12
2018-09-29
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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Treatment Free Remission
Patients entered a monitoring phase for 2 years and received 300 mg nilotinib mg bid. Patients who achieved MR4.5 entered a Consolidation Phase and were treated with nilotinib for 2 years. If MR4.5 was sustained during the Consolidation phase, patients were eligible to stop taking niltoinib during the treatment-free remission (TFR) phase.
nilotinib
Nilotinib will be provided as 150 mg capsules. Patients will take nilotinib 300mg twice daily on study and dose modifications to 450mg once daily is permitted per protocol.
Interventions
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nilotinib
Nilotinib will be provided as 150 mg capsules. Patients will take nilotinib 300mg twice daily on study and dose modifications to 450mg once daily is permitted per protocol.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Treated with at least 1 year of imatinib
* Bcr-Abl level by PCR must be less than or equal to 0.1% and greater than 0.0032% by PCR reported on the International scale confirmed during screening
* Written informed consent obtained prior to any screening procedures performed
Exclusion Criteria
* Prior imatinib failure or had accelerated phase or blast crisis CML
* Impaired cardiac function
* Pregnant or lactating women
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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University of Alabama Comprehensive Cancer Center University of Alabama (8)
Birmingham, Alabama, United States
Banner MD Anderson Cancer Center Banner MD Anderson (2)
Gilbert, Arizona, United States
Scottsdale Healthcare/TGen Clinical Research Service SC
Scottsdale, Arizona, United States
Highlands Oncology Group
Fayetteville, Arkansas, United States
City of Hope National Medical Center Dept of Oncology
Duarte, California, United States
Compassionate Care Research Group Inc CCCMG
Fountain Valley, California, United States
UC San Diego UC San Diego Cancer Ctr
La Jolla, California, United States
Wilshire Oncology Medical Group Corona Cancer Center
Multiple Locations, California, United States
Epic-Care
Pleasant Hill, California, United States
Sutter Institute for Medical Research Oncology/Hematology
Sacramento, California, United States
St Joseph Heritage Healthcare
Santa Rosa, California, United States
Rocky Mountain Cancer Centers USOR
Boulder, Colorado, United States
Florida Cancer Specialists DeptofFloridaCancerSpecialists
Fort Myers, Florida, United States
MD Anderson Cancer Center - Orlando Cancer Center
Orlando, Florida, United States
H Lee Moffitt Cancer Center and Research Institute H. Lee Moffitt Cancer Ctr (67)
Tampa, Florida, United States
Stroger Cook County Hospital Division of Hematology & Onc
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
University of Iowa Hospitals and Clinics Holden Comprehensive Cancer Ct
Iowa City, Iowa, United States
University of Kansas Hospital and Medical Center Clinical Research Center
Kansas City, Kansas, United States
Cancer Center of Kansas
Wichita, Kansas, United States
Christus Schumpert Health System
Shreveport, Louisiana, United States
Michigan State University / Breslin Cancer Center Breslin Cancer Center (3)
Lansing, Michigan, United States
Billings Clinic Billings Clinic (8)
Billings Montana, Montana, United States
Hackensack University Medical Center John Theurer Cancer Center
Hackensack, New Jersey, United States
Hematology Oncology Associates of Northern New Jersey PA Dept of Hem-Onc of Northern NJ
Morristown, New Jersey, United States
Memorial Sloan Kettering Memorial Sloan Kettering (63)
New York, New York, United States
Weill Cornell Medical Center Dept. of Oncology
New York, New York, United States
Columbia University Medical Center Herbert Irving Pavilion
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Montefiore Medical Center Montefiore Medicial Center
The Bronx, New York, United States
Westchester Medical Center NY Medical College
Valhalla, New York, United States
Duke University Medical Center Duke University Med Ctr
Durham, North Carolina, United States
Carolina Oncology Specialists, PC
Hickory, North Carolina, United States
Wake Forest University Health Sciences Hematology and Oncology
Winston-Salem, North Carolina, United States
Ohio State Comprehensive Cancer Center/James Cancer Hospital OSU Medical Center
Columbus, Ohio, United States
Northwest Cancer Specialists Compass Oncology -BKM
Portland, Oregon, United States
University of South Carolina-Hollings Cancer Center Medical University of SC
Columbia, South Carolina, United States
Tennessee Oncology Dept. of Centennial Medical
Nashville, Tennessee, United States
Vanderbilt Univeristy Ingram Cancer Center (10)
Nashville, Tennessee, United States
Hendrick Cancer Center Hendricks Cancer Center
Abilene, Texas, United States
Texas Oncology Texas Oncology - McAllen
Dallas, Texas, United States
Texas Oncology Texas Oncology - Plano West
Dallas, Texas, United States
Texas Oncology P A Texas Oncology - Midland
Dallas, Texas, United States
University of Texas Medical Branch SC
Galveston, Texas, United States
Oncology Consultants Oncology Consultants, P.A.
Houston, Texas, United States
The Methodist Hospital Cornell University
Houston, Texas, United States
South Texas Cancer Center- McAllen
McAllen, Texas, United States
Brooke Army Medical Center Brooke Army Medical
San Antonio, Texas, United States
Waco Cancer and Research Center
Waco, Texas, United States
University of Utah / Huntsman Cancer Institute Huntsman Cancer Center
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Kadlec Clinic Hematology and Oncology SC
Kennewick, Washington, United States
West Virginia University/ Mary Babb Randolph Cancer Center Mary Babb Randolph Cancer Ctr
Morgantown, West Virginia, United States
Medical College of Wisconsin Med College of WI
Milwaukee, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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CAMN107AUS37
Identifier Type: -
Identifier Source: org_study_id
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