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:
Novartis Pharmaceuticals
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
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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:
Genetics Home Reference related topics:
tetrasomy 18p
Drug Information available for:
Nilotinib
Genetic and Rare Diseases Information Center resources:
Chronic Myeloid Leukemia
Chronic Myeloproliferative Disorders
Leukemia, Myeloid
U.S. FDA Resources
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:
|
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
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:
|
Abnormal Karyotype Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Philadelphia Chromosome Bone Marrow Diseases Chromosome Aberrations |
Hematologic Diseases Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Translocation, Genetic |
ClinicalTrials.gov processed this record on March 02, 2015