Trial record 1 of 1 for:    CAMN107AUS28
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CMR Rate of Newly Diagnosed CML-CP Patients Treated With Nilotinib (MACS1428)

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: October 21, 2010
Last updated: August 21, 2015
Last verified: August 2015

"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."

Condition Intervention Phase
Chronic Myelogenous Leukemia in Chronic Phase
Drug: nilotinib
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Rate of confirmed Complete Molecular Response (CMR) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rate of CCyR, MMR, CMR and sustained CMR [ Time Frame: 4 years or at the end of the study ] [ Designated as safety issue: Yes ]
  • Time and Duration of CCyR, MMR, CMR and sustained CMR [ Time Frame: 4 years or until the end of the study ] [ Designated as safety issue: Yes ]
  • Rate and Time to progression to AP/BC [ Time Frame: 4 years or until the end of the study ] [ Designated as safety issue: Yes ]

Enrollment: 128
Study Start Date: November 2010
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nilotinib Drug: nilotinib
nilotinib 300mg b.i.d. in adult patients with newly diagnosed Ph+ CML-CP.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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.

Exclusion Criteria:

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.

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Please refer to this study by its identifier: NCT01227577

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United States, California
Pacific Cancer Medical Center, Inc.
Anaheim, California, United States, 92801
Providence St. Joseph Medical Center Roy&Patricia Disney Fam Cancer
Burbank, California, United States, 91505-6866
Bay Area Cancer Research Dept.ofBayAreaCancerResearch
Concord, California, United States, 94520
St. Jude Heritage Medical Group Virginia Crosson Cancer Center
Yorba Linda, California, United States, 92886
United States, Florida
Sarah Cannon Research Institute SCRI
Jacksonville, Florida, United States, 32256
Advanced Medical Specialties
Miami, Florida, United States, 33176
Pasco Hernando Oncology
New Port Richey, Florida, United States, 34652
United States, Georgia
Georgia Regents University MedCollege of GA Cancer Ctr 2
Augusta, Georgia, United States, 30912
United States, Illinois
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
Stroger Cook County Hospital Division of Hematology & Onc
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana Blood and Marrow Institute
Beach Grove, Indiana, United States, 46107
United States, Kansas
Cancer Center of Kansas
Witchita, Kansas, United States, 67214-3728
United States, Louisiana
New Orleans, Louisiana, United States, 70115
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Missouri
St. Louis University Cancer Center
St. Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska Medical Center University of Nebraska Med Ctr
Omaha, Nebraska, United States, 68198
United States, New Jersey
Hackensack University Medical Center Dept.of HackensackUniv.MedCtr.
Hackensack, New Jersey, United States, 07601
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
University of Rochester Medical Ct James P Wilmot Cancer Ctr
Rochester, New York, United States, 14642
United States, North Carolina
Duke University Medical Center Duke University Med Ctr
Durham, North Carolina, United States, 27710
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97201
United States, South Carolina
Cancer Centers of the Carolinas Cancer Center
Greenville, South Carolina, United States, 29605
United States, Tennessee
Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology
Chattanooga, Tennessee, United States, 37404
The Jones Clinic
Germantown, Tennessee, United States, 38138
Tennessee Oncology Sarah Cannon Research Inst.
Nashville, Tennessee, United States, 37203
United States, Texas
Baylor Research Institute Baylor Research Institute (17)
Dallas, Texas, United States, 75204
Millennium Oncology
Houston, Texas, United States, 77090
Oncology Consultants Oncology Consultants, P.A.
Houston, Texas, United States, 77024
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
United States, Washington
Providence Regional Cancer Partnership
Everett, Washington, United States, 98201
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals ) Identifier: NCT01227577     History of Changes
Other Study ID Numbers: CAMN107AUS28
Study First Received: October 21, 2010
Last Updated: August 21, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Chronic Myelogenous Leukemia

Additional relevant MeSH terms:
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Bone Marrow Diseases
Hematologic Diseases
Myeloproliferative Disorders
Neoplasms by Histologic Type processed this record on October 09, 2015