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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)

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ClinicalTrials.gov Identifier: NCT00644878
Recruitment Status : Completed
First Posted : March 27, 2008
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Myelogenous Leukemia - Chronic Phase Drug: Nilotinib Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2008
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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:
  • Tasigna
  • AMN 107


Outcome Measures
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Primary Outcome Measures :
  1. Bcr-Abl levels measured by polymerase chain reaction testing [ Time Frame: at 12 months ]

Secondary Outcome Measures :
  1. Rate of major molecular response, measured by PCR [ Time Frame: yearly ]
  2. Rate of log reduction in Bcr-Abl transcripts, measured by PCR [ Time Frame: yearly ]
  3. Time to and duration of the best molecular response, measured by PCR [ Time Frame: at end of study ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00644878


Locations
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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
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Additional Information:
Results for CAMN107AUS09 from the Novartis Clinical Trials website  This link exits the ClinicalTrials.gov site Publication (ISSN 00064971)  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00644878     History of Changes
Other Study ID Numbers: CAMN107AUS09
First Posted: March 27, 2008    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
leukemia
chronic myelogenous leukemia
chronic phase
 molecular response
nilotinib
ENABL
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Philadelphia Chromosome
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
 Hematologic Diseases
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action