A Study That Switched Patients From Imatinib to Nilotinib and Then Was Followed by Treatment Cessation

Completed · Phase 2

Conditions studied: CML

In brief

To evaluate molecular relapse free rates 6 months after stopping nilotinib therapy in patients who achieve MR4.5

Key facts

Study ID

NCT01744665

Run by

Novartis Pharmaceuticals

People needed

59

Starts

2013-08-12

Expected to finish

2018-09-29

Last updated by the study team

2020-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• diagnosis of CML
• 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

You may not qualify if…

• T315I mutation
• Prior imatinib failure or had accelerated phase or blast crisis CML
• Impaired cardiac function
• Pregnant or lactating women

Where it is running

• 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
• University of Alabama Comprehensive Cancer Center University of Alabama (8) — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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