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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
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.
USC Norris Cancer Center Jane Anne Nohl
Los Angeles, California, United States
Georgia Health Sciences University Dept. of MCG
Augusta, Georgia, United States
Indiana Blood and Marrow Institute
Beech Grove, Indiana, United States
Log Change From Baseline in Breakpoint Cluster Region Gene (BCR) - Abelson Proto-oncogene (ABL) (Bcr-Abl) Transcript Levels
The change on a logarithmic scale at 12 months from a standardized baseline value (100% on the international scale \[IS\]) in Bcr-Abl transcripts as assessed by peripheral blood Quantitative real-time polymerase chain reaction (RQ-PCR).
Time frame: From Baseline up to 12 Months
Number of Participants Who Achieved Major Molecular Response (MMR)
Major Molecular Response (MMR) value at molecular MD is designated a percentage, which is equivalent to a 3-log reduction from a standardized baseline value from the International Randomized InteYesrferon versus STI571 (IRIS) study or 0.1 percent (%) per International Scale (IS).
Time frame: From Baseline up to 12 Months
Number of Participants Achieved Reduction From a Standardized Baseline Value in Bcr-Abl Transcript Levels up to Month 12
Number of participants experiencing either a greater than or equal to (\>or=) 1, \>or= 2, or \>or= 3 log10 reduction in Bcr-Abl transcript levels from Baseline to End of Cycle (EOC) 45 (Day1219 - Day1302) were presented.
Time frame: From Baseline up to 12 Months
Median Time to Best Molecular Response
The median time to best molecular response, defined as the time (in months) from the date of enrollment to the date when the maximum reduction in Bcr-Abl transcript level was observed.
Time frame: From Start of Study up to End of the Study (up to 41 Months)
Duration of Best Molecular Response
Duration of best molecular response, defined as the time (in months) from the date of best molecular response to a date when an increase in \>1 log10 was observed
Time frame: From Start of Study up to End of the Study (up to 41 Months)
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University of Iowa Hospitals & Clinics Univ of Iowa Hosp & Clinic
Iowa City, Iowa, United States
LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center
New Orleans, Louisiana, United States
St. Agnes Hospital
Baltimore, Maryland, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, United States
South Texas Institute of Cancer
Corpus Christi, Texas, United States
Baylor College of Medicine - Breast Care Dan L Duncan Cancer Ctr
Houston, Texas, United States
Central Utah Clinic Central Utah Clinic (7)
Provo, Utah, United States
...and 1 more locations
Number of Participants With an Event-free Survival
Event-free survival was defined as the number of participants from the date of enrollment to the date of first occurrence of any of the following: loss of complete hematological response (CHR), loss of Complete cytogenetic response (CCyR), \>1 log increase in Bcr-Abl transcripts from the lowest recorded value, progression to accelerated or blast phase, and death.
Time frame: From Start of Study up to End of the Study (up to 41 Months)
Number of Participants With a Progression-free Survival
Progression-free survival was defined as the number of participants from the date of enrollment to the date of first occurrence of progression to Accelerated phase (AP) or Blast crisis (BC) phase, chronic myelogenous leukemia (CML) or death. Participants who did not have an event or dropped out without an event are considered censored at the date of the last observed event.
Time frame: From Start of Study up to End of the Study (up to 41 Months)
Number of Participants With an Overall Survival
Overall survival was defined as the number of participants from enrollment to the date of death.
Time frame: From Start of Study Enrollment up to End of the Study (up to 41 Months)