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 : Terminated (Slower than expected enrollment)
First Posted : March 27, 2008
Results First Posted : August 18, 2021
Last Update Posted : August 18, 2021
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myelogenous Leukemia - Chronic Phase||Drug: Nilotinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Log Change From Baseline in Breakpoint Cluster Region Gene (BCR) - Abelson Proto-oncogene (ABL) (Bcr-Abl) Transcript Levels [ Time Frame: From Baseline up to 12 Months ]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).
- Number of Participants Who Achieved Major Molecular Response (MMR) [ Time Frame: From Baseline up to 12 Months ]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).
- Number of Participants Achieved Reduction From a Standardized Baseline Value in Bcr-Abl Transcript Levels up to Month 12 [ Time Frame: From Baseline up to 12 Months ]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.
- Median Time to Best Molecular Response [ Time Frame: From Start of Study up to End of the Study (up to 41 Months) ]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.
- Duration of Best Molecular Response [ Time Frame: From Start of Study up to End of the Study (up to 41 Months) ]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
- Number of Participants With an Event-free Survival [ Time Frame: From Start of Study up to End of the Study (up to 41 Months) ]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.
- Number of Participants With a Progression-free Survival [ Time Frame: From Start of Study up to End of the Study (up to 41 Months) ]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.
- Number of Participants With an Overall Survival [ Time Frame: From Start of Study Enrollment up to End of the Study (up to 41 Months) ]Overall survival was defined as the number of participants from enrollment to the date of death.
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
|United States, California|
|USC Norris Cancer Center Jane Anne Nohl|
|Los Angeles, California, United States, 90033|
|United States, Georgia|
|Georgia Health Sciences University Dept. of MCG|
|Augusta, Georgia, United States, 30912|
|United States, Indiana|
|Indiana Blood and Marrow Institute|
|Beech 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, South Carolina|
|Cancer Centers of the Carolinas|
|Greenville, South Carolina, United States, 29615|
|United States, Texas|
|South Texas Institute of Cancer|
|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|
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|