EUCTR2018-001334-18-IT进行中（未招募）1 期
Cardiovascular assessment of Ponatinib as treatment option in chronic phase chronic myeloid leukemia after failure of Imatinib and Bosutinib (CarPAs) - CarPAs
Associazione Italiana Pazienti Leucemia Mieloide Cronica (AIPLMC)0 个研究点目标入组 50 人开始时间: 2020年10月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1)Signed and dated Informed Consent approved by Local Ethical Committee before any protocol-specific screening procedures.
- •2)CML diagnosis, Chronic Phase (CP), treated with imatinib and bosutinib or bosutinib only. Previous treatment with dasatinib or nilotinib will not be allowed.
- •3)Resistant or intolerant to imatinib and/or bosutinib.
- •4)Able to take oral therapy.
- •5)Female or male, 18 years of age or older.
- •6)ECOG performance status 0-2.
- •7)Minimum life expectancy of 3 months or more.
- •8)Adequate organ function as defined by the following criteria:
- •-Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) = 2.5 x upper limit of normal (ULN) or AST and ALT = 5 x ULN if liver function abnormalities are due to underlying malignancy
- •-Total serum bilirubin = 1.5 x ULN (except patients with documented Gilbert’s syndrome)
- •-Creatinine = 1.5 x ULN
- •-Prothrombin time (PT) < 1.5 × ULN
- •-Lipase = 1.5 × ULN for institution
- •-Amylase = 1.5 × ULN for institution
- •9)Normal QTcF interval on screening electrocardiogram (ECG) evaluation, defined as QTcF of = 450 ms in males or = 470 ms in females.
- •10)Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- •11)Female and male patients who are of childbearing potential must agree to use a highly effective method of contraception with a failure rate of less than 1% per year (2 forms of contraception, hormonal and barrier) with their partners throughout participation in this study and for at least 90 days after the last dose of treatment.
- •12)For females of childbearing potential, a negative pregnancy test must be documented prior to enrolment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1)Current treatment on another therapeutic clinical trial.
- •2)Received TKI therapy within 7 days prior to receiving the first dose of ponatinib, or have not recovered (> grade 1 by NCI CTCAE, v. 4.0) from AEs (except alopecia) due to agents previously administered.
- •3)Underwent autologous or allogeneic stem cell transplant < 60 days prior to receiving the first dose of ponatinib; any evidence of on-going graft versus-host disease (GVHD), or GVHD requiring immunosuppressive therapy.
- •4)Take medications that are known to be associated with Torsades de Pointes.
- •5)Require concurrent treatment with immunosuppressive agents, other than corticosteroids prescribed for a short course of therapy.
- •6)Have previously been treated with ponatinib.
- •7)Have active central nervous system (CNS) disease as evidenced by cytology or pathology. In the absence of clinical CNS disease, lumbar puncture is not required. History itself of CNS involvement is not exclusionary if CNS has been cleared with a documented negative lumbar puncture.
- •8)Have significant or active cardiovascular disease, specifically including, but not restricted to:
- •a. Myocardial infarction within 3 months prior to first dose of ponatinib,
- •b. History of clinically significant atrial arrhythmia or any ventricular arrhythmia,
- •c. Unstable angina within 3 months prior to first dose of ponatinib,
- •d. Congestive heart failure within 3 months prior to first dose of ponatinib.
- •9)Have a significant bleeding disorder unrelated to CML or Ph+ ALL.
- •10)Have a history of pancreatitis or alcohol abuse.
- •11)Have uncontrolled hypertriglyceridemia (triglycerides > 450 mg/dL).
- •12)Have malabsorption syndrome or other gastrointestinal illness that could affect absorption of orally administered ponatinib.
- •13)Have been diagnosed with another primary malignancy within the past 3 years (except for non-melanoma skin cancer or cervical cancer in situ, or controlled prostate cancer, which are allowed within 3 years).
- •14)Pregnancy or breastfeeding
- •15)Underwent major surgery (with the exception of minor surgical procedures, such as catheter placement or BM biopsy) within 14 days prior to first dose of ponatinib
- •16)Have ongoing or active infection (including known history of human immunodeficiency virus [HIV] or hepatitis C virus [HCV]). Testing for these viruses is not required in the absence of history
- •17) Be positive for blood serum for Hepatitis B serology (Hepatitis B surface Antigen, Hepatitis B core Antibody, and Hepatitis B surface Antibody) at the time of screening
- •18)Other severe acute or chronic medical or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration
- •19) Known hypersensitivity to one of IMP’s excipients, which is lactose monohydrate (rare hereditary galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption)
研究者
相似试验
尚未招募
2 期
Cardiovascular Assessment of Ponatinib as Third Line Treatment in Chronic Phase Chronic Myeloid LeukemiaChronic Myeloid Leukemia (CML)NCT04709731Associazione Italiana Pazienti Leucemia Mieloide Cronica50
Unknown
不适用
Vascular Cardiotoxicity of PonatinibCardiotoxicityNCT03930394Oregon Health and Science University32
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)Acute Myeloid Leukaemia (FLT3-ITD positive)Cancer - Leukaemia - Acute leukaemiaACTRN12614000810617Australasian Leukaemia and Lymphoma Group35
进行中（未招募）
1 期
A Randomized, Open-label Study of Ponatinib Versus Nilotinib in Patients with Chronic Myeloid Leukemia in Chronic Phase Following Resistance to ImatinibEUCTR2015-001318-92-FRARIAD Pharmaceuticals, Inc.600
进行中（未招募）
1 期
A Randomized, Open-label Study of Ponatinib Versus Nilotinib in Patients with Chronic Myeloid Leukemia in Chronic Phase Following Resistance to ImatinibChronic Phase Chronic Myeloid LeukemiaMedDRA version: 18.0Level: LLTClassification code 10054352Term: Chronic phase chronic myeloid leukemiaSystem Organ Class: 100000004864EUCTR2015-001318-92-BEARIAD Pharmaceuticals, Inc.600