An open-label Bosutinib treatment extension study for subjects with Chronic Myeloid Leukemia (CML) who have previously participated in bosutinib studies B1871006 or B1871008
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- 1.Long term safety of bosutinib, including type, incidence, severity, timing, seriousness and relatedness of AEs and laboratory abnormalities as well as reason of treatment discontinuation. A special focus will be made on diarrhea in order to satisfy the EMA post-commitment request
研究概览
简要总结
This is an open-label bosutinib treatment extension protocol. This protocol will be offered to those bosutinib subjects who were previously enrolled in one of the two parent CML bosutinib studies (B1871006 or B1871008).
Subjects to be enrolled will include those who – at the time of this protocol approval – are still receiving bosutinib in either one of the parent studies and are benefiting from bosutinib treatment as judged by the investigator, as well as those subjects who have already discontinued bosutinib as part of the parent studies and are in follow up for survival. The former group will continue to receive bosutinib as part of the extension study; the latter group will only enter into the long term survival follow up part of the extension study.
In addition to that and in order to have the most accurate and unbiased statistical analysis of long term survival, the maximum number of subjects who have received bosutinib should be enrolled in the extension study including those who have completed the 2 years of follow-up as planned in the study B1871006 and then discontinued the study. For this purpose every efforts should be made to re-contact all the subjects who have completed the parent study B1871006 and offer themthe opportunity to participate in the extension study.
Each patient will remain in the extension study,either on Bosutinib treatment or in long-term survival follow-up phase,until the last patient has reached 10 years of follow-up, as calculated from the date of his/her first dose of Bosutinib administered in the parent study.
After that period, the present study will be closed, and the subjects still benefiting from bosutinib will switch to the most appropriate therapy available at that time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- •Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
- •Previous enrollment in the bosutinib arm of one of the two Pfizer parent studies: B1871006 or B
- •This includes: a.
- •Subjects still receiving bosutinib in either study B1871006 or B1871008; b.
- •Subjects who have discontinued bosutinib but are still in the long term follow-up phase of the stude B1871006 or B1871008; c.
- •Subjects from study B1871006 who have discontinued bosutinib and have already completed the long term follow-up period.
- •Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 30 days after the last dose of assigned treatment.
- •A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
排除标准
- •Subjects presenting with any of the following will not be included in the study:
- •Participation in other studies involving investigational drug(s) (Phases 1-4) while subject in the active treatment phase of the current study.
- •Subjects who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator, or subjects who are Pfizer employees directly involved in the conduct of the trial.
- •Other severe acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
- •Pregnant females; breastfeeding females; males and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for at least 30 days after last dose of investigational product.
结局指标
主要结局
1.Long term safety of bosutinib, including type, incidence, severity, timing, seriousness and relatedness of AEs and laboratory abnormalities as well as reason of treatment discontinuation. A special focus will be made on diarrhea in order to satisfy the EMA post-commitment request
时间窗: Disease status for pts is assessed according to local SOC.1st-line chronic phase pts will be followed for safety,survival&BCR-ABL mutation status,study visits-12months&phone visit-3months. 2nd&later line pts have visits-6months&phone visit-3months, At all visits emphasis will be on dosing compliance&patient safety.Efficacy assessed includes duration of hematologic&cytogenetic response,progression-free survival&time to transformation from accelerated to blast phase disease.
2.BCR -ABL mutations present at the time subjects discontinue bosutinib
时间窗: Disease status for pts is assessed according to local SOC.1st-line chronic phase pts will be followed for safety,survival&BCR-ABL mutation status,study visits-12months&phone visit-3months. 2nd&later line pts have visits-6months&phone visit-3months, At all visits emphasis will be on dosing compliance&patient safety.Efficacy assessed includes duration of hematologic&cytogenetic response,progression-free survival&time to transformation from accelerated to blast phase disease.
3.Overall survival (OS)
时间窗: Disease status for pts is assessed according to local SOC.1st-line chronic phase pts will be followed for safety,survival&BCR-ABL mutation status,study visits-12months&phone visit-3months. 2nd&later line pts have visits-6months&phone visit-3months, At all visits emphasis will be on dosing compliance&patient safety.Efficacy assessed includes duration of hematologic&cytogenetic response,progression-free survival&time to transformation from accelerated to blast phase disease.
次要结局
- Duration of hematologic and cytogenetic responses.(NA)
- Progression free survival.(NA)
- Time to transformation to accelerated or blast phase.(NA)