CMR Rate of Newly Diagnosed CML-CP Patients Treated With Nilotinib
MACS1428
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)
1 other identifier
interventional
128
1 country
32
Brief Summary
"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."
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2010
Longer than P75 for phase_4
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2010
CompletedFirst Posted
Study publicly available on registry
October 25, 2010
CompletedStudy Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedResults Posted
Study results publicly available
February 8, 2016
CompletedFebruary 8, 2016
January 1, 2016
4 years
October 21, 2010
November 19, 2015
January 11, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Confirmed Complete Molecular Response (CMR)
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.
4 years
Secondary Outcomes (8)
Number of Participants With Complete Cytogenetic Response (CCyR) and Major Molecular Response (MMR)
4 years
Time to CMR, CCyR and MMR
4 years
Duration of CMR, CCyR and MMR
4 years
Number of Participants With Progression to Accelerated Phase/Blastic Crisis (AP/BC)
4 years
Time to Progression of AP/BC
4 years
- +3 more secondary outcomes
Study Arms (1)
Nilotinib
EXPERIMENTALParticipants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
Interventions
Eligibility Criteria
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:
- Impaired cardiac function as defined by the protocol. Patients with contraindications to receiving nilotinib, including concomitant medications.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Pacific Cancer Medical Center, Inc.
Anaheim, California, 92801, United States
Providence St. Joseph Medical Center Roy&Patricia Disney Fam Cancer
Burbank, California, 91505-6866, United States
Bay Area Cancer Research Dept.ofBayAreaCancerResearch
Concord, California, 94520, United States
St. Jude Heritage Medical Group Virginia Crosson Cancer Center
Yorba Linda, California, 92886, United States
Sarah Cannon Research Institute SCRI
Jacksonville, Florida, 32256, United States
Advanced Medical Specialties
Miami, Florida, 33176, United States
Pasco Hernando Oncology
New Port Richey, Florida, 34652, United States
Georgia Regents University MedCollege of GA Cancer Ctr 2
Augusta, Georgia, 30912, United States
Stroger Cook County Hospital Division of Hematology & Onc
Chicago, Illinois, 60612, United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640, United States
Indiana Blood and Marrow Institute
Beach Grove, Indiana, 46107, United States
Cancer Center of Kansas
Witchita, Kansas, 67214-3728, United States
LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center(3)
New Orleans, Louisiana, 70115, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
St. Louis University Cancer Center
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center University of Nebraska Med Ctr
Omaha, Nebraska, 68198, United States
Hackensack University Medical Center Dept.of HackensackUniv.MedCtr.
Hackensack, New Jersey, 07601, United States
University of Rochester Medical Ct James P Wilmot Cancer Ctr
Rochester, New York, 14642, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Duke University Medical Center Duke University Med Ctr
Durham, North Carolina, 27710, United States
Oregon Health & Science University
Portland, Oregon, 97201, United States
Cancer Centers of the Carolinas Cancer Center
Greenville, South Carolina, 29605, United States
Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology
Chattanooga, Tennessee, 37404, United States
The Jones Clinic
Germantown, Tennessee, 38138, United States
Tennessee Oncology Sarah Cannon Research Inst.
Nashville, Tennessee, 37203, United States
Baylor Research Institute Baylor Research Institute (17)
Dallas, Texas, 75204, United States
Oncology Consultants Oncology Consultants, P.A.
Houston, Texas, 77024, United States
Millennium Oncology
Houston, Texas, 77090, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Providence Regional Cancer Partnership
Everett, Washington, 98201, United States
Related Publications (1)
Berdeja JG, Heinrich MC, Dakhil SR, Goldberg SL, Wadleigh M, Kuriakose P, Cortes J, Radich J, Helton B, Rizzieri D, Paley C, Dautaj I, Mauro MJ. Rates of deep molecular response by digital and conventional PCR with frontline nilotinib in newly diagnosed chronic myeloid leukemia: a landmark analysis. Leuk Lymphoma. 2019 Oct;60(10):2384-2393. doi: 10.1080/10428194.2019.1590569. Epub 2019 Mar 26.
PMID: 30912699DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2010
First Posted
October 25, 2010
Study Start
November 1, 2010
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
February 8, 2016
Results First Posted
February 8, 2016
Record last verified: 2016-01