EUCTR2013-003117-18-DE进行中（未招募）1 期
Randomized Phase III Study of Intensive Chemotherapy with or without Dasatinib (Sprycel™) in Adult Patients with Newly Diagnosed Core-Binding Factor Acute Myeloid Leukemia (CBF-AML)AMLSG 21-13 - AMLSG 21-13
niversity Hospital Ulm0 个研究点目标入组 203 人开始时间: 2014年4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）
- 发起方
- 入组人数
- 203
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
- •Core-binding factor (CBF) AML with molecular diagnosis of RUNX1-RUNX1T1 fusion transcript resulting from t(8;21)(q22;q22) (or a variant form) or of CBFB-MYH11 fusion transcript resulting from inv(16)(p13.1q22)/t(16;16)(p13.1;q22) as assessed in one of the central AMLSG reference la-boratories (Ulm, Hannover)
- •Age = 18; there is no upper age limit
- •No prior chemotherapy for leukemia except hydroxyurea for up to 5 days during the diagnostic screening phase
- ••Non-pregnant and non-nursing. Due to the unknown teratogenic potential of dasatinib in humans, pregnant or nursing patients may not be enrolled. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within a sensitivity of at least 25 mIU/mL with-in 72 hours prior to registration. Women of child-bearing potential must either commit to contin-ued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control - one highly effective method (e.g., IUD, hormonal, tubal ligation, or partner’s vasectomy), and one additional effective method (e.g., latex condom, diaphragm, or cervical cap) - AT THE SAME TIME, at least four weeks before she begins dasatinib therapy until at least 3 months after last dasatinib administration. Women of childbearing potential” is defined as a sexually active mature woman who has not undergone a hysterectomy or who has had menses at any time in the preced-ing 24 consecutive months.
- •Men must agree not to father a child and must use a latex condom during any sexual contact with women of childbearing potential while taking dasatinib and for 3 months after therapy is stopped, even if they have undergone a successful vasectomy.
- •Signed written informed consent.
- •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 193
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Performance status WHO >2
- •Pulmonary edema and/or pleural/pericardial effusion within 14 days of day 1. If edema/effusion resolves to CTC Grade =1, patients can be treated with dasatinib.
- •Patients with ejection fraction <50% by echocardiography or MUGA within 14 days of day 1
- •Organ insufficiency (creatinine >1.5x upper normal serum level; bilirubin, AST or AP >2.5x upper normal serum level; heart failure NYHA III/IV; severe obstructive or restrictive ventilation disorder)
- •Uncontrolled infection
- •Patients with a currently active” second malignancy other than non-melanoma skin cancers. Pa-tients are not considered to have a currently active” malignancy, if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse within one year.
- •Severe neurological or psychiatric disorder interfering with ability of giving an informed consent
- •Known positive for HIV, active HBV, HCV, or Hepatitis A infection
- •Bleeding disorder independent of leukemia
- •No consent for registration, storage and processing of the individual disease characteristics and course as well as information of the family physician and/or other physicians involved in the treatment of the patient about study participation.
- •No consent for biobanking.
研究者
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