EUCTR2011-002567-17-DE进行中（未招募）1 期
A single-arm phase II trial to assess the efficacy of Midostaurin (PKC412) added to standard primary therapy in patients with newly diagnosed c-KIT or FLT3-ITD mutated t(8;21) AML - MIDOKIT
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
- 18
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
入选标准
- •Diagnosis of c-KIT and/or FLT3-ITD mutated t(8;21) AML i.e.
- •o >20% myeloid blasts in bone marrow and/or peripheral blood at initial diagnosis
- •o Plus cytogenetic diagnosis of aberration t(8;21)/AML1-ETO
- •o Plus mutation of c-KIT gene (mut-KIT17 or mut-KIT8) or FLT3-ITD mutation or both c-KIT and FLT3-ITD mutations
- •Chemo-responsive disease* as determined by early bone marrow assessment on day 14-16 after first cycle of standard induction therapy with seven-day continuous infusion of 100-200 mg/m2 cytarabine per day in combination with three doses of daunorubicine, or idarubicine, or mitoxantrone
- •Age 18 – 65 years
- •Fit for intensive chemotherapy as assessed by
- •o Adequate liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
- •? Total bilirubin = 1.5 times the upper limit of normal
- •? ALT and AST = 2.5 times upper limit of normal
- •? Creatinine = 1.5 times upper limit of normal
- •o Adequate cardiac function, i.e. left ventricular ejection fraction (LVEF) of >= 50% as assessed by transthoracal twodimensional echocardiography (M Mode”) or MUGA scan
- •ECOG performance status of 0-2
- •Life expectancy of at least 12 weeks
- •Subject's written informed consent has been obtained
- •Legal capacity (see also exclusion criterion)
- •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 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
排除标准
- •- Primary refractory or previously relapsed AML
- •- Non-eligibility for high-dose cytarabine based consolidation, e.g. intolerance to cytarabine
- •- Inability to swallow oral medications
- •- Symptomatic congestive heart failure as defined by left ventricular ejection fraction (LVEF) of =50% as assessed by transthoracal twodimensional echocardiography (M Mode”) or MUGA scan
- •- Subject without legal capacity who is unable to understand the nature, significance and consequences of the study
- •- Investigational drug therapy outside of this trial during or within 4 weeks of study entry
- •- Known or persistent abuse of medication, drugs or alcohol
研究者
相似试验
撤回
不适用
A single arm phase II trial to evaluate the efficacy of Poziotinib, pan HER inhibitor in recurrent/metastatic esophageal cancerKCT0003833Yonsei University Health System, Severance Hospital49
尚未招募
2 期
Biomarcer-2 :Biomarker informed optimal management of advanced RAS wild type colorectal cancerAdvanced RAS Wild type right sided Colorectal cancerCancer - Bowel - Back passage (rectum) or large bowel (colon)ACTRN12623000874617Australasian Gastrointestinal Trials Group29
招募中
2 期
A study to check the efficacy of Osimertinib when given with Savolitinib in Patients with Lung Cancer who have progressed after Treatment with OsimertinibCTRI/2019/08/020845AstraZeneca AB
进行中（未招募）
不适用
A single arm Phase II study to assess efficacy and safety of bevacizumab in combination with the standard therapy (interferon alfa-2a and vinblastine) as first-line treatment for patients with metastatic renal cell cancer (Bevacizumab with standard therapy in RCC) - Bevacizumab with standard therapy in RCCMetastatic renal cell cancerEUCTR2005-006161-13-DERoche Pharma AG
招募中
2 期
A clinical trial to evaluate the effect of low-dose atovaquone on the prevention of pneumocystis pneumonia in patients with rheumatic diseasesRheumatic DiseasesJPRN-jRCTs031210557Furuta Syunsuke50