HEAT-AML (Hydroxyurea-Enhanced Ara-C Treatment of Adult Acute Myeloid Leukaemia): A phase I/II multicenter study to assess the tolerability and efficacy of the addition of hydroxyurea to standard ara-C and daunorubicin-based therapy for adults (age = 18 years of age) with newly diagnosed acute myeloid leukaemia (AML) - HEAT-AM

niversity Hospital Karolinska0 个研究点目标入组 69 人开始时间: 2019年6月4日最近更新: 2019年11月25日

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•Patients with:
•- a diagnosis of AML and related myeloid precursor neoplasia according to WHO 2008 classification (excluding acute promyelocytic leukemia) including secondary AML (after an antecedent hematological disease (e.g. MDS) and therapy-related AML, or
•- acute leukaemia of ambiguous lineage according to WHO 2008
•Patients 18 years and older.
•Adequate renal and hepatic functions unless clearly disease related as indicated by the following laboratory values:
•- Serum creatinine = 220 µmol/L, unless considered AML-related
•- Serum bilirubin = 2.5 x upper limit of normal (ULN, i.e. =65 µmol/L), unless considered AML-related or due to Gilbert’s syndrome
•- Alanine aminotransferase (ALAT) = 2.5 x ULN, i.e. = 1.9 µcat/L and = 2.9 for females and males, respectively, unless considered AML-related
•Male patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
•Written informed consent.
•Patient is capable of giving 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 36
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 33

•Acute promyelocytic leukemia.
•CNS leukaemia
•Ongoing treatment with gemtuzumab-ozogamicin.
•Major organ failure precluding administration of planned chemotherapy.
•Glomerular filtration rate (GFR) < 30 ml/min
•Cardiac dysfunction as defined by:
•- Myocardial infarction within the last 3 months of study entry, or
•- Reduced left ventricular function with an ejection fraction < 40% as measured by echocardiogram (will only be performed when clinically suspected) or
•- Unstable angina or
•- New York Heart Association (NYHA) grade IV congestive heart failure (see Appendix I) or
•- Unstable cardiac arrhythmias
•Known intolerance to any of the chemotherapeutic drugs in the protocol.
•Positive pregnancy test. Lactating female or female of childbearing potential not using adequate contraception.
•Fanconi anaemia
•Patients with a history of non-compliance to medical regimens or who are considered unreliable with respect to compliance.

发起方

niversity Hospital Karolinska