A clincal trial to study the effects of Bosutinib (SKI-606) compared with Imatinib in patients newly diagnosed with philadelphia chromosome positive chronic myelogenous leukemia (CML).
- Conditions
- -C921 Chronic myeloid leukaemia [CML], BCR/ABL-positiveChronic myeloid leukaemia [CML], BCR/ABL-positiveC921
- Registration Number
- PER-130-08
- Lead Sponsor
- ABORATORIOS WYETH S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 0
• Cytogenetic diagnosis of CML in chronic phase Ph + diagnosed for <6 months.
• Adequate liver and kidney function.
• ECOG performance status of 0 or 1.
• Age> 18 years.
• Recovered at • 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.
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>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.<br>Measure:Full Cytogenetic Response Rate (CCyR) at one year<br>Timepoints:48 weeks<br>
- Secondary Outcome Measures
Name Time Method