During the Core Phase of the study, participants received STI571 at a dose of 400 milligrams (mg) daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study provided that, in the opinion of the investigator, they had benefited from treatment with STI571 and there were no safety concerns.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
532
STI571 oral capsules or tablets.
Percentage of Participants With Cytogenetic Response (Complete Cytogenetic Response and Major Cytogenetic Response) to STI571
Response was evaluated from bone marrow aspirates and biopsy samples. Bone marrow cytogenetic studies were performed every 3 months during the core phase of the study, then twice yearly, then annually to evaluate Philadelphia chromosome positive (Ph+). Cytogenetic response was defined as the best response the participant achieved during study. Based on the percentage of Ph+ cells = (positive cells/ examined cells) x100, at each BM assessment the cytogenetic response was classified as: Complete Cytogenetic Response (CCyR):, 0% Ph+ cells; Partial Cytogenetic Response (PCyR):, \>0 - 35% Ph+ cells; Minor: \>35 - 65% Ph+ cells; and Minimal: \>65 - 95% Ph+ cells, None: \>95 % Ph+ cells and Not done: \<20 metaphases were examined and/or response could not be assigned. Major Cytogenetic Response (MCyR) was defined as sum of the CCyR plus PCyR rates.
Time frame: Up to 6 years after the start of treatment
Percentage of Participants With Complete Hematologic Response to STI571
Hematologic response was evaluated from hematology measurements in the peripheral blood. Complete hematological response was defined as normalization of peripheral blood counts \[WBC and platelet count \< upper limit of normal (ULN) at the laboratory where the analysis was performed\], with a normal WBC differential, and no immature granulocytes present, lasting for 4 weeks.
Time frame: 12 months after the start of treatment
Duration of Complete Hematologic Response to STI571
Duration of hematologic response was defined as the time from the first documentation of the complete hematologic response to the date the loss of complete hematologic response is documented. Loss of complete hematological response was defined as a rising WBC count (increased to a level above the ULN at the laboratory where the analysis was performed confirmed by two samples obtained one month apart). The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time. Complete hematological response was defined as normalization of peripheral blood counts (WBC and platelet count \< ULN at the laboratory where the analysis was performed), with a normal WBC differential, and no immature granulocytes present, lasting for 4 weeks.
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UCLA Medical Center
Los Angeles, California, United States
H. Lee Moffet Cancer Center & Research Institute/Univ of South Florida
Tampa, Florida, United States
Northwestern Univ meical School/Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, United States
Johns Hopkins Oncology Center
Baltimore, Maryland, United States
Dana Faber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Wayne State University/Kamanos Cancer Center
Detroit, Michigan, United States
C/O V. Ward - Washington Univ. school of Medicine
St Louis, Missouri, United States
New York Presbyterian Hospital
New York, New York, United States
Oregon Health & sciences University
Portland, Oregon, United States
...and 18 more locations
Time frame: 12 months after the start of treatment
Time to Complete Hematologic Response to STI571
Time to Complete Hematologic Response was defined for all participants with calculated confirmed complete hematologic response as the time until first documented response (which was confirmed \>= 4 weeks). Complete hematological response was defined as normalization of peripheral blood counts (WBC and platelet count \< ULN at the laboratory where the analysis was performed), with a normal WBC differential, and no immature granulocytes present, lasting for 4 weeks.
Time frame: 12 months after the start of treatment
Number of Participants With Common Toxicity Criteria Grade 3 or 4 Cancer-related Symptoms
National Cancer Institute (NCI)/ National Institute of Health (NIH) provides a grading (severity) scale for each adverse event (AE) term, the Common Toxicity Criteria (CTC). Grade 3 refers to severe AE and Grade 4 refers to life-threatening or disabling AE. Cancer-related symptoms included fever, night sweats, bone pain, arthralgia, abdominal discomfort, fatigue and anorexia.
Time frame: Up to 9 months after the start of treatment
Number of Participants With Grade 3 or 4 Eastern Cooperative Oncology Group (ECOG) Performance Status
The ECOG performance status was recorded at baseline and every 3 months during the core study. The ECOG Performance Scale has 5 grades. 0 = Fully active, able to carry out all pre-disease activities; 1 = Restricted in strenuous activity but ambulatory and able to carry out work of light or sedentary nature; 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Active about 50% of waking hours; 3 = Capable of limited self-care, confined to bed/chair more than 50% of waking hours; 4 = Completely disabled; cannot carry on self-care. Totally confined to bed/chair.
Time frame: Up to 9 months after the start of treatment
Percentage of Participants Alive Over Time Based on Kaplan-Meier Estimates
Overall survival was defined as the time from the first dose of STI571 to the death of the participant. If a participant is not known to have died, survival was censored at the time of last contact. Kaplan-Meier estimates of the percentage of participants at each time point was calculated.
Time frame: 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 and 156 months