None listed
Conditions
Interventions
Group 1 Type of group
The subjects will take a daily oral dose of 500mg of bosutinib with food preferably during the morning.
Group name:Group 2 Type of group
Subjects will take a daily oral dose of 400mg of imatinib. Subjects may increase the dose of imatinib or bosutinib to 600 mg / day if CHR is not achieved after 12 weeks of treatment, if MCyR is not achieved after 24 weeks of treatment, if CCyR is not achieved after 48 weeks of treatment, if there is total loss of complete hematological response or total loss of cytogenetic response.
Sponsors
LABORATORIOS WYETH S.A.,
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: • Cytogenetic diagnosis of CML in chronic phase Ph + diagnosed for 18 years. • Recovered at <grade 1 or baseline of all toxicities caused by a previous cancer treatment. • Negative serum pregnancy test within two weeks of the first dose of the test product if the subject is a woman with the potential to have children. A woman with the potential to have children is defined as the one who has the biological capacity to get pregnant. This includes women who are using contraceptives or whose sexual partners are either sterile or are using contraceptives. • Disposition of all subjects who are not sterile by surgical procedures or who are not postmenopausal to accept using a reliable method of birth control during the study and for 28 days after receiving the last dose of the test product.
Exclusion criteria
Exclusion criteria: • CML Philadelphia chromosome negative. • Previous treatment against leukemia. Up to 6 months of prior treatment with hydroxyurea or anagrelide is allowed. • Stem cell donor identified with planned transplant within 12 months of randomization. • Previous stem cell transplant • Leukemia of the central nervous system. • Extramedullary disease only. • History of CML in accelerated or blast phase. • Radiation therapy or major surgery within 14 days of randomization. • Concomitant use or need for medications known to prolong the QT interval. • History of uncontrolled heart disease or clinical significance. • Known seropostivity to HIV, acute or chronic current hepatitis B (positive surface antigen hepatitis B), hepatitis C or cirrhosis. • Recent or ongoing gastrointestinal disorder with clinical significance. • Evidence of serious active or significant medical infection or psychiatric illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The CCyR rate will be evaluated for subjects who participate in both arms after one year of treatment through a cytogenetic analysis conducted by local laboratories to the study centers. In this study, a CCyR is counted only if the response is demonstrated in the one-year visit (week 48); A CCyR won and lost before the one-year visit is considered as no response. Measure:Full Cytogenetic Response Rate (CCyR) at one year Timepoints:48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The duration of the response (CCyR, CHR, MMR) is measured from the first date of response to the first date of loss of response, documented objectively. The duration of the response will be recorded as O days for subjects who do not respond in the ITT analysis. A conditional analysis of the duration of the response will also be carried out using only subjects who respond to the treatment. Measure:Major molecular response rate (MMR) at one year Timepoints:48 weeks ; Outcome name:The duration of the response (CCyR, CHR, MMR) is measured from the first date of response to the first date of loss of response, documented objectively. The duration of the response will be recorded as O days for subjects who do not respond in the ITT analysis. A conditional analysis of the duration of the response will also be carried out using only subjects who respond to the treatment. Measure:Duration of CCyR Timepoints:48 weeks ; Outcome name:The time to transformation to AP / BP is defined as the time from randomization to the first date of transformation to AP or BP. Measure:Time to transformation to accelerated phase or blast phase Timepoints:48 weeks | — |
Countries
Argentina, Belgium, Brazil, Canada, Chile, China, Colombia, France, Germany, Hungary, India, Italy, Japan, Korea South, Latovia, Lithuania, Mexico, Peru, Poland, Russian Federation, Singapore, Slovenia, South Africa, Spain, Taiwan, Thailand, Turkey, Ukraine, United Kindgdom, United States
Contacts
Public ContactJuan Navarro
LABORATORIOS WYETH S.A.
Outcome results
None listed