Study of Molecular Response in Adult Patients on Nilotinib With Philadelphia Chromosome Positive Chronic Myelogenous Leukemia (Ph+ CML) in Chronic Phase and a Suboptimal Molecular Response to Imatinib (MACS0254)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00644878
First received: March 19, 2008
Last updated: December 3, 2013
Last verified: April 2013
  Purpose

This exploratory study will evaluate the change in molecular response in chronic myelogenous leukemia - chronic phase patients with a complete cytogenetic response and have a suboptimal molecular response to imatinib


Condition Intervention Phase
Chronic Myelogenous Leukemia - Chronic Phase
Drug: Nilotinib
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-center, Open-label, Exploratory Study of Bcr-Abl Kinetics in Adult Patients on Nilotinib With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) and a Suboptimal Molecular Response to Imatinib

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Bcr-Abl levels measured by polymerase chain reaction testing [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of major molecular response, measured by PCR [ Time Frame: yearly ] [ Designated as safety issue: No ]
  • Rate of log reduction in Bcr-Abl transcripts, measured by PCR [ Time Frame: yearly ] [ Designated as safety issue: No ]
  • Time to and duration of the best molecular response, measured by PCR [ Time Frame: at end of study ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: October 2008
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nilotinib Drug: Nilotinib
Nilotinib 300 mg is taken by mouth twice a day at 12 hour intervals. Nilotinib is to be taken with water on an empty stomach. No food two hours prior to the dose of nilotinib and for one hour following the dose.
Other Names:
  • Nilotinib
  • Tasigna
  • AMN 107

  Eligibility

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

Select Inclusion Criteria:

  • Male or female patients
  • 18 years of age with a con-firmed diagnosis of Ph+ CML-CP and CCyR
  • Patients treated with an imatinib dose of 400 mg qd (at least 6 consecutive months for Group 1 patients)
  • A suboptimal molecular response to imatinib defined as:

    • Group 1: Treated with 1 year of imatinib, CCyR but no MMR (Bcr-Abl levels >0.1%IS);
    • Group 2: No specific duration of imatinib required, achieved CCyR but has >1 log increase in Bcr-Abl transcript levels
  • Adequate end organ function

Select Exclusion Criteria:

  • Prior accelerated phase or blast crisis CML
  • Patients achieving prior CCyR on imatinib who lost cytogenetic response prior to entering study
  • Previously documented T315I mutations
  • Prior therapy with any other tyrosine kinase inhibitor except imatinib
  • 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: NCT00644878

Locations
United States, California
USC Norris Cancer Center Jane Anne Nohl
Los Angeles, California, United States, 90033
United States, Florida
Innovative Medical Research of South Florida Dept.ofInnovativeMedResearch
Miami Shores, Florida, United States, 33138
United States, Georgia
Georgia Health Sciences University Dept. of MCG
Augusta, Georgia, United States, 30912
United States, Idaho
Kootenai Medical Center Dept.ofKootenai Med.Ctr.
Coeur d'Alene, Idaho, United States, 83814
United States, Indiana
Indiana Blood and Marrow Institute
Beach Grove, Indiana, United States, 46107
United States, Iowa
University of Iowa Hospitals & Clinics Univ of Iowa Hosp & Clinic
Iowa City, Iowa, United States, 52242
United States, Louisiana
LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center
New Orleans, Louisiana, United States, 70115
United States, Maryland
St. Agnes Hospital
Baltimore, Maryland, United States, 21229
United States, New York
Montefiore Medical Center Medical Center
Bronx, New York, United States, 10467
SUNY Upstate Medical Center
Syracuse, New York, United States, 13210
Westchester Medical Center Munger Pavillion (2)
Valhalla, New York, United States, 10595
United States, North Carolina
Wake Forest University Baptist Medical Center Hematology and Oncology
Winston-Salem, North Carolina, United States, 27157
United States, South Carolina
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29615
United States, Tennessee
University of Tennessee Cancer Institute Cancer Institute
Memphis, Tennessee, United States, 38104
United States, Texas
South Texas Institute of Cancer S. Tex Inst.- Corpus Christi
Corpus Christi, Texas, United States, 78405
Baylor College of Medicine - Breast Care Dan L Duncan Cancer Ctr
Houston, Texas, United States, 77030
United States, Utah
Central Utah Clinic Central Utah Clinic (7)
Provo, Utah, United States, 84604
United States, Wisconsin
Froedert Memorial Lutheran Hospital Dept.ofFroedert Memorial
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00644878     History of Changes
Other Study ID Numbers: CAMN107AUS09
Study First Received: March 19, 2008
Last Updated: December 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
leukemia
chronic myelogenous leukemia
chronic phase
molecular response
nilotinib
ENABL

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Abnormal Karyotype
Philadelphia Chromosome
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Chromosome Aberrations
Pathologic Processes
Translocation, Genetic

ClinicalTrials.gov processed this record on September 18, 2014