EUCTR2019-003871-20-IT进行中（未招募）1 期
Phase III study to assess the impact of gemtuzumab ozogamicin, in combination with standard chemotherapy, on the levels of minimal residual disease, and the role of glasdegib as a post-transplant maintenance, in adult patients, aged 18-60 years, with previously untreated, de novo, favorable-intermediate-risk acute myeloid leukemia. - AML1819
FONDAZIONE GIMEMA (GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL' ADULTO) FRANCO MANDELLI ONLUS0 个研究点目标入组 414 人开始时间: 2021年5月24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
- 414
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
- •1Signed written informed consent according to ICH/EU/GCP and national/local laws
- •2Patients aged between 18 and 60 years
- •3 Patients previously untreated for their AML by other chemotherapeutic agents (except for no more than 14 days HU) or radiotherapy
- •4 Unequivocal diagnosis of de novo AML according to WHO diagnostic criteria (at least 20% blasts in the bone marrow), other than 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 = 6 months duration)
- •5 Patients with favorable-intermediate AML according to ELN 2017 (except for FLT3-ITD/TKD positive AML)
- •6 WHO performance status 0-3
- •7 Adequate renal (serum creatinine = 2 x the institutional ULN) and liver (total serum bilirubin = 2 x ULN; serum ALT and AST = 2.5 x ULN) function, unless considered due to organ leukemic involvement
- •8 Left Ventricular Ejection Fraction (LVEF) = 50%, as determined by echocardiogram
- •9 Absence of severe concomitant neurological or psychiatric diseases and congestive heart failure or active uncontrolled infection
- •10 Absence of any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and the follow-up schedule.
- •11 Women of childbearing potential with a negative serum pregnancy test within 48 hrs prior to administration of chemotherapy. Post-menopausal women with amenorrhoic for at least 12 months to be considered of non-childbearing potential. Male and female patients agreed to employ an effective barrier method of birth control throughout the study and for at least 6 months following discontinuation of study drug.
- •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 414
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients already treated for their AML by other chemotherapeutic agents (except for no more than 14 days HU) or radiotherapy
- •2. Acute promyelocytic leukemia
- •3. Blast crisis of chronic myeloid leukemia
- •4. FLT3-ITD/TKD positive AML
- •5. AML supervening after other myeloproliferative disease = 6 months duration
- •6. AML supervening after antecedent myelodysplastic syndromes
- •7. Therapy-related AML
- •8. Other active or progressive malignant diseases.
- •9. Inadequate renal or liver function (see no. 7 Inclusion )
- •10. Severe heart failure requiring diuretics
- •11. Ejection fraction < 50%
- •12. Uncontrolled infections
- •13. HIV positive serology
- •14. Severe concomitant neurological or psychiatric diseases
- •15. Patients who are pregnant or adults of reproductive potential not employing an effective method of birth control.
研究者
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