EUCTR2016-001083-11-IT进行中（未招募）1 期
D-ALBA Front-Line Sequential Treatment of Adult Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) Patients with Dasatinib and the Bispecific Monoclonal Antibody Blinatumomab - LAL 2116
FONDAZIONE GIMEMA (GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL' ADULTO) FRANCO MANDELLI ONLUS0 个研究点目标入组 63 人开始时间: 2020年11月4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）
- 发起方
- 入组人数
- 63
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) Newly diagnosed adult B-precursor Ph+ ALL patients.
- •2) Age greater or equal to18 years.
- •3) Signed written informed consent according to ICH/EU/GCP and national local laws.
- •4) ECOG Performance Status 0 or 1 and/or WHO performance status less or equal to 2.
- •5) Renal and hepatic function as defined below:
- •o AST (GOT), ALT (GPT), and AP <2 x upper limit of normal (ULN) o Total bilirubin <1.5 x ULN
- •o Creatinine clearance equal or greater than 50 mL/min
- •6) Pancreatic function as defined below:
- •o Serum amylase less or equal to 1.5 x ULN
- •o Serum lipase less or equal to1.5 x ULN
- •7) Normal cardiac function.
- •8) Negative HIV test, negative HBV DNA and HCV RNA.
- •9) Negative pregnancy test in women of childbearing potential.
- •10) Bone marrow specimen from primary diagnosis available.
- •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 33
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1) Prior systemic chemotherapy for leukemia and/or CD19-directed therapy
- •2) History of or current relevant CNS pathology (current =grade 2 epilepsy, seizure, paresis, aphasia, clinically relevant apoplexia, severe brain injuries, dementia, Parkinson’s disease, organic brain syndrome, psychosis).
- •3) Impaired cardiac function, including any one of the following:
- •-LVEF (Left Ventricular Ejection Fraction) <45% as determined by MUGA (multigated acquisition) scan or echocardiogram.
- •-Complete left bundle branch block.
- •-Use of a cardiac pacemaker.
- •-ST depression of >1mm in 2 or more leads and/or T wave inversions in 2 or more contiguous leads.
- •-Congenital long QT syndrome.
- •-History of or presence of significant ventricular or atrial arrhythmia.
- •-Clinically significant resting bradycardia (<50 beats per minute).
- •-QTc >450 msec on screening ECG (using the QTcF formula).
- •-Right bundle branch block plus left anterior hemiblock, bifascicular block.
- •-Myocardial infarction within 3 months prior to starting Dasatinib.
- •-Angina pectoris.
- •4) Other clinically significant heart disease (e.g., congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen).
- •5) Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of Dasatinib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
- •6) History of or current autoimmune disease.
- •7) Systemic cancer chemotherapy within 2 weeks prior to study.
- •8) Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation.
- •9) Active malignancy other than ALL with the exception of basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
- •10) Active infection, any other concurrent disease or medical condition that are deemed to interfere with the conduct of the study as judged by the investigator.
- •11) Nursing women or women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least 3 months thereafter, or male patients not willing to ensure effective contraception during participation in the study and at least three months thereafter.
研究者
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