CMR Rate of Newly Diagnosed CML-CP Patients Treated With Nilotinib

Completed · Phase 4

Conditions studied: Chronic Myelogenous Leukemia in Chronic Phase

In brief

"This is a single-arm, open-label, multi-center study of complete molecular response (CMR) in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP). The study is designed to evaluate early and deep molecular responses up to 4 years on nilotinib treatment. The primary end point is Rate of confirmed CMR in newly diagnosed Philadelphia chromosome positive CML-CP patients."

Key facts

Study ID

NCT01227577

Run by

Novartis Pharmaceuticals

People needed

128

Starts

2010-11-01

Expected to finish

2014-11-01

Last updated by the study team

2016-02-08

Who can join

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

You may qualify if…

• Patients with Ph+ CML-CP within 3 months of diagnosis. Male or female patients' ≥ 18 years of age. Patients must have adequate end organ function.

You may not qualify if…

• Previously documented T315I mutation. Other CML treatment is an exclusion criteria with the following exception: While awaiting study start, patients may be treated with anagrelide (no treatment duration limit), hydroxyurea (no treatment duration limit), and/or up to a 14 day supply of a tyrosine kinase inhibitor (TKI) approved by the FDA for frontline treatment. Patients taking a TKI prior to study entry must have at least a one day washout from their last dose of medication and have recovered from any side effects of such therapy.
• Impaired cardiac function as defined by the protocol. Patients with contraindications to receiving nilotinib, including concomitant medications.

Where it is running

• Pacific Cancer Medical Center, Inc. — Anaheim, California, United States
• Providence St. Joseph Medical Center Roy&Patricia Disney Fam Cancer — Burbank, California, United States
• Bay Area Cancer Research Dept.ofBayAreaCancerResearch — Concord, California, United States
• St. Jude Heritage Medical Group Virginia Crosson Cancer Center — Yorba Linda, California, United States
• Sarah Cannon Research Institute SCRI — Jacksonville, Florida, United States
• Advanced Medical Specialties — Miami, Florida, United States
• Pasco Hernando Oncology — New Port Richey, Florida, United States
• Georgia Regents University MedCollege of GA Cancer Ctr 2 — Augusta, Georgia, United States
• Stroger Cook County Hospital Division of Hematology & Onc — Chicago, Illinois, United States
• Louis A. Weiss Memorial Hospital — Chicago, Illinois, United States
• Indiana Blood and Marrow Institute — Beach Grove, Indiana, United States
• Cancer Center of Kansas — Witchita, Kansas, United States
• LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center(3) — New Orleans, Louisiana, United States
• University of Maryland — Baltimore, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• St. Louis University Cancer Center — St Louis, Missouri, United States
• University of Nebraska Medical Center University of Nebraska Med Ctr — Omaha, Nebraska, United States
• Hackensack University Medical Center Dept.of HackensackUniv.MedCtr. — Hackensack, New Jersey, United States
• University of Rochester Medical Ct James P Wilmot Cancer Ctr — Rochester, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Duke University Medical Center Duke University Med Ctr — Durham, North Carolina, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Cancer Centers of the Carolinas Cancer Center — Greenville, South Carolina, United States
• Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology — Chattanooga, Tennessee, United States

Full record on ClinicalTrials.gov

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