CMR Rate of Newly Diagnosed CML-CP Patients Treated With Nilotinib (MACS1428)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01227577
First received: October 21, 2010
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

"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: 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 ]

Estimated Enrollment: 125
Study Start Date: November 2010
Estimated Study Completion Date: November 2014
Estimated 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.

  Eligibility

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

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01227577

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Hide Study Locations
Locations
United States, Arkansas
Hematology Oncology Services of Arkansas SC Not yet recruiting
Little Rock, Arkansas, United States, 72205
Contact    501-320-3217      
Principal Investigator: Brad Baltz         
United States, California
Pacific Cancer Medical Center, Inc. Active, not recruiting
Anaheim, California, United States, 92801
Providence St. Joseph Medical Center Roy&Patricia Disney Fam Cancer Active, not recruiting
Burbank, California, United States, 91505-6866
Bay Area Cancer Research Dept.ofBayAreaCancerResearch Recruiting
Concord, California, United States, 94520
Contact    925-932-9700      
Principal Investigator: Robert Robles         
Compassionate Cancer Care Medical Group Dept.ofCCCMG-Riverside Not yet recruiting
Fountain Valley, California, United States, 92708
Contact    951-276-2760      
Principal Investigator: Brian Choi         
Compassionate Cancer Care Medical Group CCCMG Not yet recruiting
Fountain Valley, California, United States, 92708
Contact    714-698-0300      
Principal Investigator: Haresh Jhangiani         
Redwood Regional Medical Group - Santa Rosa Not yet recruiting
Santa Rosa, California, United States, 94503
Contact    707-525-3930      
Principal Investigator: Marek Bozdech         
The Oncology Institute of Hope and Innovation Not yet recruiting
Whitter, California, United States, 90606
Contact    562-698-6888      
Principal Investigator: Merrill Shum         
St. Jude Heritage Medical Group Virginia Crosson Cancer Center Active, not recruiting
Yorba Linda, California, United States, 92886
United States, Colorado
University of Colorado Colorado Univ Not yet recruiting
Aurora, Colorado, United States, 80045
Contact    720-848-0655      
Principal Investigator: Jonathan Gutman         
Denver Health Medical Center CACZ885M2301 Not yet recruiting
Denver, Colorado, United States, 80204-4507
Contact    303-602-3893      
Principal Investigator: Michael McLaughlin         
United States, Florida
Cancer Care of North Florida, P.A. Cancer Care - Lake City, FL (2 Not yet recruiting
Lake City, Florida, United States, 32024
Principal Investigator: Waseem Khan         
Advanced Medical Specialties Active, not recruiting
Miami, Florida, United States, 33176
Pasco Hernando Oncology Active, not recruiting
New Port Richey, Florida, United States, 34652
United States, Georgia
Georgia Regents University MedCollege of GA Cancer Ctr 2 Active, not recruiting
Augusta, Georgia, United States, 30912
United States, Illinois
Stroger Cook County Hospital Division of Hematology & Onc Active, not recruiting
Chicago, Illinois, United States, 60612
Rush-Presbyterian St. Luke's Medical Center Not yet recruiting
Chicago, Illinois, United States, 60612
Contact    312-942-5689      
Principal Investigator: Jamile Shammo         
Louis A. Weiss Memorial Hospital Active, not recruiting
Chicago, Illinois, United States, 60640
Northwest Oncology & Hematology Cancer Institute Not yet recruiting
Elk Grove Village, Illinois, United States, 60007
Contact    847-437-3312      
Principal Investigator: Bruce Bank         
United States, Indiana
Indiana Blood and Marrow Institute Active, not recruiting
Beach Grove, Indiana, United States, 46107
United States, Kansas
Cancer Center of Kansas Active, not recruiting
Witchita, Kansas, United States, 67214-3728
United States, Louisiana
Cabrini Center for Cancer Care Not yet recruiting
Alexandria, Louisiana, United States, 71301
Contact    318-448-6917      
Principal Investigator: Steven Saccaro         
LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center(3) Recruiting
New Orleans, Louisiana, United States, 70115
Contact    318-813-1410      
Principal Investigator: Nebu Koshy         
United States, Maryland
St. Agnes Hospital SC Not yet recruiting
Baltimore, Maryland, United States, 21229
Contact    410-368-2966      
Principal Investigator: Carole Miller         
U of Maryland Active, not recruiting
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Dana Farber Cancer Institute Active, not recruiting
Boston, Massachusetts, United States, 02115
United States, Michigan
Henry Ford Hospital Active, not recruiting
Detroit, Michigan, United States, 48202
United States, Missouri
St. Louis University Cancer Center Active, not recruiting
St. Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska Medical Center University of Nebraska Med Ctr Active, not recruiting
Omaha, Nebraska, United States, 68198
United States, New Jersey
Hackensack University Medical Center Dept.of HackensackUniv.MedCtr. Active, not recruiting
Hackensack, New Jersey, United States, 07601
St. Joseph's Regional Medical Center St. Joseph's Regional MC (3) Not yet recruiting
Paterson, New Jersey, United States, 07503
Contact    862-591-2002      
Principal Investigator: Michael Maroules         
United States, New York
Montefiore Medical Center Active, not recruiting
Bronx, New York, United States, 10467
U of Rochester Medical Ct James P Wilmot Cancer Ctr Active, not recruiting
Rochester, New York, United States, 14642
SUNY at Stony Brook SUNY at Stony Brook 2 Not yet recruiting
Stony Brook, New York, United States, 11794-8161
Contact    212-746-2119      
Principal Investigator: Michael A. Schuster         
United States, North Carolina
Duke University Medical Center Duke University Med Ctr Recruiting
Durham, North Carolina, United States, 27710
Principal Investigator: David Moore         
United States, Ohio
University Hospital University Hospital (2) Not yet recruiting
Cincinnati, Ohio, United States, 45219-2316
Principal Investigator: Tahir Latif         
United States, Oregon
Oregon Health & Science University Active, not recruiting
Portland, Oregon, United States, 97201
United States, Pennsylvania
Penn State University / Milton S. Hershey Medical Center Penn Milton Hershey Ctr (2) Not yet recruiting
Hershey, Pennsylvania, United States, 17033-085
Principal Investigator: David Claxton         
United States, South Carolina
Cancer Centers of the Carolinas Cancer Center Active, not recruiting
Greenville, South Carolina, United States, 29605
United States, Tennessee
Chattanooga Oncology and Hematology Assoicates, PC SC Active, not recruiting
Chattanooga, Tennessee, United States, 37404
The Jones Clinic Active, not recruiting
Germantown, Tennessee, United States, 38138
Tennessee Oncology Sarah Cannon Research Inst. Active, not recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Baylor Research Institute Baylor Research Institute (17) Active, not recruiting
Dallas, Texas, United States, 75204
Oncology Consultants Oncology Consultants, P.A. Active, not recruiting
Houston, Texas, United States, 77024
Millennium Oncology Active, not recruiting
Houston, Texas, United States, 77090
United States, Virginia
University of Virginia Active, not recruiting
Charlottesville, Virginia, United States, 22908
United States, Washington
Providence Regional Cancer Partnership Active, not recruiting
Everett, Washington, United States, 98201
United States, West Virginia
St. Mary's Medical Center Not yet recruiting
Huntington, West Virginia, United States, 25702
Contact    304-528-4658      
Principal Investigator: Avinder Bir         
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01227577     History of Changes
Other Study ID Numbers: CAMN107AUS28
Study First Received: October 21, 2010
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
CML
Chronic Myelogenous Leukemia
Leukemia
CML-CP
Nilotinib

Additional relevant MeSH terms:
Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Bone Marrow Diseases
Hematologic Diseases
Myeloproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 23, 2014