ACTRN12614000810617进行中（未招募）1 期
A phase Ib/II clinical evaluation of Ponatinib in combination with 5- Azacitidine in patients failing prior therapy for FLT3-ITD positive acute myeloid leukaemia (AMLM21)
Australasian Leukaemia and Lymphoma Group0 个研究点目标入组 35 人开始时间: 2014年7月30日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Provision of written informed consent
- •2. Enrolment to the ALLG National Blood Cancer Registry (Another Australiasian Leukaemia and Lymphoma group study)
- •3. FLT3-ITD AML (except Acute Promyelocytic Leukaemia) failing prior chemotherapy (excluding hydroxyurea and thioguanine which is not considered chemotherapy) or who are considered unfit for frontline intensive chemotherapy.
- •4. Age 18+
- •5. Eastern Cooperative Oncology Group performance status 0-2
- •6. Adequate haemostatic function (activated partial thromboplastin time (APTT) within 5 sec of ULN and INR less than 1.4x ULN)
- •7. Adequate hepatic function as defined by bilirubin less than or equal to 1.5 x the upper limit of normal (ULN) unless due to Gilbert’s syndrome and aspartate transaminase (AST) or alanine aminotransferase (ALT) less than or equal to 3 x ULN
- •8. Adequate pancreatic function as defined by the following criterion: serum lipase or amylase less than or equal to 1.5 × ULN
- •9. Adequate renal function as defined by serum creatinine less than 1.5
排除标准
- •1. Any serious medical condition which the investigator feels may interfere with the procedures or evaluations of the study
- •2. More than 2 prior lines of intensive chemotherapy
- •3. Prior exposure to ponatinib
- •4. If prior exposure to other FLT3 inhibitors, the presence of FLT3-TKD mutation must not be present at screening
- •5. Moderate/strong CYP3A4 inhibitors within 48 hours of cycle 1, day 1
- •6. Active graft versus host disease post-allograft or requiring steroid doses equivalent to prednisolone 15mg per day or greater
- •7. Prior exposure to a hypomethylating agent
- •8. Major surgery within 28 days prior to initiating therapy
- •9. History of acute pancreatitis within 1 year of study or a history of chronic pancreatitis
- •10. Uncontrolled diabetes
- •11. History of cardiovascular or thromboembolic disease including:
- •a. Myocardial infarction
- •b. Unstable angina within 6 months prior to randomization
- •c. Congestive heart failure within 6 months prior to randomization
- •d. History of clinically significant (as determined by the treating physician) atrial arrhythmia
- •e. Any history of ventricular arrhythmia
- •f. Cerebrovascular accident or transient ischemic attack
- •g. Any history of peripheral arterial occlusive disease requiring revascularization
- •h. Any history of venous thromboembolism including deep venous thrombosis (excluding catheter associated thrombosis) or pulmonary embolism
- •12. History of other malignancy requiring active systemic treatment or which is likely to result in an expected survival time of less than 2 years
- •13. Viral infection with known HIV or viral hepatitis type B or C not adequately controlled by antiviral medication
- •14. Active infection or bleeding
- •15. Pregnant or breastfeeding females; women of childbearing potential may participate providing they agree to use at least 2 effective contraceptive methods throughout the study and for 30 days following completion. For females of childbearing potential, a negative pregnancy test must be documented within 7 days prior to starting treatment with ponatinib
- •16. Males with a female partner of childbearing potential must agree to use at least 2 effective contraceptive methods throughout the study and for 30 days following the date of last dose
研究者
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