Management of Transformed Chronic myeloid leukaemia: Ponatinib and Intensive chemotherapy: a dose finding trial

niversity of Birmingham (UK)0 个研究点目标入组 17 人开始时间: 2014年3月5日最近更新: 2021年12月27日

适应症

试验速览

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34906334/ (added 16/12/2021)

•All of the following:
•1. Ph positive or BCRABL positive CML in blastic transformation. Defined as one or more of the following being present: Blasts =30% in peripheral blood or bone marrow Extramedullary blast proliferation or large foci or clusters of blasts in the bone marrow biopsy
•2. Age: =18
•3. Suitable for intensive chemotherapy (FLAGIDA)
•4. Adequate renal function defined as serum creatinine =1.5 X upper limit of normal (ULN)
•5. Adequate liver function defined as: Total bilirubin < 1.5 X ULN Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 2.5 X ULN (< 5 X ULN if liver involvement with leukaemia)
•6. Normal pancreatic status Lipase = 1.5 X ULN and Amylase = 1.5 X ULN
•7. Normal QTcF interval on screening ECG evaluation, defined as QTcF of = 450 ms in males or =470 ms in females.
•8. Female and male patients who are of childbearing potential must agree to use an effective form of contraception with their sexual partners throughout participation in this study until 30 days after the last dose of ponatinib.
•9. Ability to comply with study procedures, in the Investigator's opinion.
•10. Valid Informed Consent

•1. Received chemotherapy other than hydroxycarbamide or anagrelide within 4 weeks of registration
•2. Received therapy with a new TKI (i.e. changed TKI) following confirmation of blastic transformation up to two weeks of TKI therapy is allowed for those patients whose CML is in blastic phase at original diagnosis.
•3. Previous treatment with intensive acute leukaemiastyle chemotherapy (FLAGIDA)
•4. Prior allogeneic or autologous Stem Cell Transplant
•5. Significant or active cardiovascular disease, specifically including but not restricted to:
•Myocardial infarction within 6 months prior to registration
•History of clinically significant atrial or ventricular arrhythmia
•Unstable angina within 6 months prior to registration
•Congestive heart failure within 6 months prior to registration
•History of pancreatitis
•6. Uncontrolled hypertriglyceridaemia (>450mg/dL)
•7. Are pregnant or lactating
•8. Underwent major surgery (with the exception of minor surgical procedures, such as catheter placement or Bone Marrow biopsy) within 14 days prior to registration
•9. Suffer from any condition or illness that, in the opinion of the investigator, would compromise patient safety or interfere
•with the evaluation of the safety of the study treatment

发起方

niversity of Birmingham (UK)