CTIS2024-516048-24-00进行中（未招募）1 期
OPEN LABEL PHASE 2 STUDY ON THE EFFICACY AND TOLERANCE OF A COMBINATION OF PONATINIB AND 5-AZACITIDINE IN CHRONIC MYELOGENOUS LEUKAEMIA IN ACCELERATED PHASE OR IN MYELOID BLAST CRISIS - PONAZA_P16/23
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Patient aged 18 years or more, Agree to use an effective form of contraception with sexual partners throughout study participation (for female and male patients who are fertile)., Have fully recovered (= grade 1, returned to baseline, or deemed irreversible) from the acute effects of prior cancer therapy before initiation of study drug, Patient affiliated to or beneficiary of the French National Health Service, Signed informed consent, Patient with Philadelphia chromosome positive CML in blast crisis: MBC-CML is defined by the presence of = 20% blasts in the bone marrow and/or peripheral blood or the presence of extramedullary disease., Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 or 3., Have adequate renal function as defined by the following criterion: Serum creatinine = 1.5 × upper limit of normal (ULN) for institution, Have adequate hepatic function as defined by the following criteria: a.Total serum bilirubin = 1.5 × ULN, unless due to Gilbert’s syndrome or CML / b.Alanine aminotransferase (ALT) = 2.5 × ULN, or = 5 × ULN unless related to the disease / c.Aspartate aminotransferase (AST) = 2.5 × ULN, or = 5 × ULN unless related to the disease, Have normal pancreatic status as defined by serum lipase and/or amylase = 1.5 × ULN, Have normal QTcF interval on screening electrocardiogram (ECG) evaluation, defined as QTcF of = 450 ms in males or = 470 ms in females., Have a negative pregnancy test documented prior to enrolment (for females of childbearing potential).
排除标准
- •Pregnant or lactating women, Intake of medications with a known risk of Torsades de Pointes, Have active central nervous system (CNS) disease as evidenced by cytology or pathology., Have uncontrolled hypertension (diastolic blood pressure > 90 mmHg; systolic > 150 mmHg). Patients with hypertension should be under treatment on study entry to affect blood pressure control., Have any condition or illness that, in the opinion of the investigator, would compromise patient’s safety or interfere with the evaluation of the drug, Participation in another clinical trial with any investigative drug within 30 days prior to study enrolment, Prior history of hematopoietic stem cell transplantation, Cardiovascular disease: Stage II to IV congestive heart failure (CHF) as determined by the New York Heart Association (NYHA) classification system for heart failure. / Myocardial infarction within the previous 6 months / Symptomatic cardiac arrhythmia requiring treatment, Individuals with another active malignancy, Patients at high risk or very high risk of arterio-veinous occlusive disease defined by European CVD score ( appendix 9), Previously treated by 5-azacitidine or cytotoxic chemotherapy other than hydroxyurea, Diagnosis of malignant disease within the previous 12 months (excluding base cell carcinoma, in-situ carcinoma of the cervix or breast or other local malignancy excised or irradiated with a high probability of cure), Active viral infection with Human Immunodeficiency Virus (HIV) or Hepatitis type B or C
研究者
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