Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Trial record 1 of 1 for:    CAMN107AUS28
Previous Study | Return to List | Next Study

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01227577
First received: October 21, 2010
Last updated: January 11, 2016
Last verified: January 2016
  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:
  • Number of Participants With Confirmed Complete Molecular Response (CMR) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    CMR was defined as at least 4.5 log reduction of breakpoint cluster region gene/Abelson proto-oncogene (Bcr-Abl) transcipts from the standardized baseline on the international scale (equivalent to Bcr-Abl <=0.0032% IS) with a minimum of 25,614 ABL control copies. CMR was to be confirmed by a second polymerase chain reaction (PCR) sample drawn 3 months later where the results should be less than or equal to 0.0032% with a minimum of 25,614 Abelson proto-oncogene (ABL) control copies.


Secondary Outcome Measures:
  • Number of Participants With Complete Cytogenetic Response (CCyR) and Major Molecular Response (MMR) [ Time Frame: 4 years ] [ Designated as safety issue: No ]

    CCyR was defined as 0% Philadelphia chromosome-positive (Ph+) metaphases in the bone marrow. MMR was defined as a 3 log reduction of Bcr-Abl transcripts from the standardized baseline on the international scale (equivalent to Bcr-Abl ≤ 0.1% IS).

    Bcr-Abl transcripts assessed by peripheral blood quatitative real time polymerase chain reaction (RQ-PCR) were used for the determination of all molecular responses.


  • Time to CMR, CCyR and MMR [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Time to CMR, CCyR, and MMR was defined as the time from the date of enrollment to the date of first documented CMR, CCyR and MMR, respectively.

  • Duration of CMR, CCyR and MMR [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Duration of CMR, CCyR and MMR were defined as the time from the first date of achievement of the response to the date of first documented loss of the response.

  • Number of Participants With Progression to Accelerated Phase/Blastic Crisis (AP/BC) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Progression to AP/BC is defined as loss of CCyR, MMR, and CMR and was summarized by frequencies and percentages.

  • Time to Progression of AP/BC [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Time to progression of AP/BC was defined as the time from the date of the first dose of study drug to the date of first documented progression of AP/BC.

  • Number of Participants With Loss of CCyR, MMR and CMR [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Rate of loss of CMR was defined as an increase in the Bcr-Abl transcripts to greater than 0.0032% IS. Rate of loss of CCyR was defined as an increase in the Ph+ bone marrow cells to greater than 0%. Rate of loss of MMR was defined as an increase in the Bcr-Abl transcripts to greater than 0.1% IS.

  • Number of Participants With CMR Who Were Dosed to 400 mg b.i.d. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    CMR was defined as at least 4.5 log reduction of breakpoint cluster region gene/Abelson proto-oncogene (Bcr-Abl) transcipts from the standardized baseline on the international scale (equivalent to Bcr-Abl <=0.0032% IS) with a minimum of 25,614 ABL control copies. CMR was to be confirmed by a second polymerase chain reaction (PCR) sample drawn 3 months later where the results should be less than or equal to 0.0032% with a minimum of 25,614 Abelson proto-oncogene (ABL) control copies.

  • Event-free Survival, Progression-free Survival and Overall Survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Event-free survival was defined as the time from the date of enrollment to the date of first occurrence of any of the following: loss of Complete Hematological Response (CHR), loss of CCyR, loss of Partial Cytogenetic Response (PCyR), progression to the accelerated phase or blast crisis, and death from any cause. Progression-free survival was defined as the time from the date of enrollment to the date of first occurrence of any of the following: progression to the accelerated phase or blast crisis, death, and loss of CMR. Overall survival was defined as the time from the date of enrollment until death due to any cause.


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
Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
Drug: Nilotinib
Nilotinib was supplied as 150 mg and 200 mg hard gelatin capsules.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

  Hide Study Locations
Locations
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
Stroger Cook County Hospital Division of Hematology & Onc
Chicago, Illinois, United States, 60612
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
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
LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center(3)
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
Oncology Consultants Oncology Consultants, P.A.
Houston, Texas, United States, 77024
Millennium Oncology
Houston, Texas, United States, 77090
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
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01227577     History of Changes
Other Study ID Numbers: CAMN107AUS28 
Study First Received: October 21, 2010
Results First Received: November 19, 2015
Last Updated: January 11, 2016
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, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on December 02, 2016