EUCTR2010-023809-36-IT进行中（未招募）1 期
Risk-adapted, MRD-directed therapy for young adults with newly diagnosed acute myeloid leukemia. - GIMEMA AML1310
G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO0 个研究点目标入组 237 人开始时间: 2012年3月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 237
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
- •- Signed written informed consent according to ICH/EU/GCP and national/local laws - Patients aged between 18 and 60 years - Patients previously untreated for their AML by other chemotherapeutic agents (with the exception of no more than 7 days HU), radiotherapy or more than 7 days corticosteroids - Unequivocal diagnosis of untreated de novo AML according to WHO diagnostic criteria (at least 20% blasts in the bone marrow), with FAB classification other than M3 (acute promyelocytic leukemia), documented by bone marrow aspiration (or biopsy in case of dry tap) (not supervening after other myeloproliferative disease or myelodysplastic syndromes of more than 6 months duration) - WHO performance status 0-3 - Adequate renal (serum creatinine < 2 x the institutional ULN) and liver (total serum bilirubin < 2 x ULN; serum ALT and AST = 3 x ULN) function, unless considered due to organ leukemic involvement - Left Ventricular Ejection Fraction (LVEF) >50%, as determined by echocardiogram - Absence of severe concomitant neurological or psychiatric diseases and congestive heart failure or active uncontrolled infection - Absence of any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and the follow-up schedule.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 237
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Patients aged less than 18 or more than 60 years - Patients already treated for their AML by other chemotherapeutic agents (with the exception of no more than 7 days HU), radiotherapy or more than 7 days corticosteroids - Acute promyelocytic leukaemia - Blast crisis of chronic myeloid leukaemia - AML supervening after other myeloproliferative disease - AML supervening after antecedent myelodysplastic syndromes of more than 6 months duration - Other progressive malignant diseases. However, secondary AML following previously cured malignancies may be included as well as secondary AML following previous exposure to alkylating agents or radiation for other reason - Inadequate renal or liver function (metabolic abnormalities > 3 times the normal upper limit) - Severe heart failure requiring diuretics - Ejection fraction < 50% - Uncontrolled infections - WHO performance status = 4 - Severe concomitant neurological or psychiatric diseases - Patients who are pregnant or adults of reproductive potential not employing an effective method of birth control. Women of childbearing potential must have a negative serum pregnancy test within 48 hrs prior to administration of Dasatinib. Post-menopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Male and female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug.
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