The purpose of this study is to evaluate and compare the side effects and anti-leukemic benefits of imatinib with those of interferon and Ara-C for patients who have chronic myeloid leukemia (CML) in the chronic phase. Patients in this study will be randomized (1:1) to receive either interferon plus Ara-C or imatinib as initial treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,106
imatinib supplied as 100 mg and 400 mg tablets or 100 mg capsules.
interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m\^2/day.
cytarabine 20 mg/m\^2/day (max 40 mg) SC for 10 days every month.
Kaplan-Meier Estimates of Overall Survival (All Randomized Participants)
Overall survival was defined as the time between date of randomization and death due to any cause. The time was censored at last examination date for patients who were still being treated and at date of last contact for patients who discontinued treatment. Kaplan-Meier estimates of the percentage of participants at each time point was calculated. This outcome was measured in all randomized patients, regardless of whether crossover occurred, i.e., events that occurred in patients, who had crossed over, were attributed following crossover to the original randomized treatment.
Time frame: 12,24,36,48,60,72,84,96,108,120,132 and 144 months
Kaplan Meier Estimates of Event Free Survival (All Randomized Participants)
Event-free survival is defined as the time between randomization and the earliest of any of the following events on treatment: * progression to Accelerated Phase (AP) or Blast Crisis (BC) * loss of Complete Hematological Response (CHR) * loss of Major Cytogenetic Response (MCyR) confirmed * loss of Major Cytogenetic Response (MCyR) unconfirmed * increase in white blood cell count (WBC) if approved by the Study Management Committee (SMC) * death (due to any cause when reported as primary reason for discontinuation of treatment). Kaplan Meier estimates of the percentage of participants with Event Free Survival at the given time point was calculated. This outcome was measured in all randomized patients, regardless of whether crossover occurred, i.e., events that occurred in patients, who had crossed over, were attributed following crossover to the original randomized treatment.
Time frame: 12,24,36,48,60,72,84,96,108,120,132 and 144 months
Percentage of Participants With Event Free Survival Events (All Randomized Participants)
Event-free survival is defined as the time between randomization and the earliest of any of the following events on treatment: * progression to Accelerated Phase (AP) or Blast Crisis (BC) * loss of Complete Hematological Response (CHR) * loss of Major Cytogenic Response (MCyR) confirmed * loss of Major Cytogenic Response (MCyR) unconfirmed * increase in white blood cell count (WBC) if approved by the Study Management Committee (SMC) * death (due to any cause when reported as primary reason for discontinuation of treatment). The percentage of participants with Event Free Survival events in each category was calculated. This outcome was measured in all randomized patients, regardless of whether crossover occurred, i.e., events that occurred in patients, who had crossed over, were attributed following crossover to the original randomized treatment.
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Novartis Investigative Site
Birmingham, Alabama, United States
Novartis Investigative Site
Montgomery, Alabama, United States
Novartis Investigative Site
Tucson, Arizona, United States
Novartis Investigative Site
Berkeley, California, United States
Novartis Investigative Site
Campbell, California, United States
Novartis Investigative Site
Duarte, California, United States
Novartis Investigative Site
La Jolla, California, United States
Novartis Investigative Site
Denver, Colorado, United States
Novartis Investigative Site
Miami, Florida, United States
Novartis Investigative Site
Orlando, Florida, United States
...and 153 more locations
Time frame: 144 months
Kaplan Meier Estimates of Time to Progression to Accelerated Phase (AP) or Blast Crisis (BC) (All Randomized Participants)
Time to progression to AP/BC is defined as the time between randomization and either of the following events on treatment: death (due to CML when reported as primary reason for discontinuation of treatment) or progression to Accelerated Phase or Blast Crisis and is censored at last examination date for patients without event. No data after discontinuation of study treatment was included. The Kaplan Meier estimates of the percentage of participants with survival without progression to AP/BC at the given time point was calculated. This outcome was measured in all randomized patients, regardless of whether crossover occurred, i.e., events that occurred in patients, who had crossed over, were attributed following crossover to the original randomized treatment.
Time frame: 12,24,36,48,60,72,84,96,108,120,132 and 144 months
Percentage of Participants With Best Cytogenetic Response (First-line Treatment)
Bone marrow aspirate was performed to evaluate cytogenetic results (percentage of Philadelphia chromosome positive (Ph+) metaphases) and amount of blasts and promyelocytes in bone marrow to establish cytogenetic response. Major Cytogenetic Response= Complete Response or Partial Response. Complete Cytogenetic Response= 0 % of Ph+ metaphases (out of 20 metaphases). Partial Cytogenetic Response= \> 0 and ≤ 35 % of Ph+ metaphases (out of 20 metaphases). The percentage of participants with cytogenetic response in each category was calculated.
Time frame: 144 months
Percentage of Participants With Best Cytogenetic Response (Second-line Treatment)
Bone marrow aspirate was performed to evaluate cytogenetic results (percentage of Ph chromosome (Ph+) containing metaphases) and the amount of blasts and promyelocytes in bone marrow to establish cytogenetic response. Major Cytogenetic Response= Complete Response or Partial Response. Complete Cytogenetic Response= 0 % of Ph+ metaphases (out of 20 metaphases). Partial Cytogenetic Response= \> 0 and ≤ 35 % Ph+ metaphases (out of 20 metaphases). The percentage of participants with cytogenetic response in each category was calculated.
Time frame: 144 months
Number of Participants With Serious Adverse Events as a Measure of Safety (First-line Treatment)
A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant
Time frame: 144 months
Number of Participants With Serious Adverse Events as a Measure of Safety (Second-line Treatment)
A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant
Time frame: 144 months
Percentage of Participants With Major Molecular Response (First-line Treatment)
Major Molecular Response was determined using a quantitative polymerase chain reaction (PCR) laboratory test and was defined as BCR-ABL protein transcripts of ≤ 0.1% according to the international scale.
Time frame: 12,24,36,48,60,72,84,96,108,120,132 and 144 months
Percentage of Participants With Major Molecular Response (Second-line Treatment)
Major Molecular Response was determined using a quantitative polymerase chain reaction (PCR) laboratory test and was defined as BCR-ABL protein transcripts of ≤ 0.1% according to the international scale.
Time frame: 12,24,36,48,60,72,84,96,108,120,132 and 144 months