HEAT-AML (Hydroxyurea-Enhanced Ara-C Treatment of Adult Acute Myeloid Leukaemia): A clinical study to assess whether addition of hydroxyurea to standard treatment against acute myeloid leukaemia (AML) is safe and efficacious

Phase 1

Conditions: ewly diagnosed acute myeloid leukaemia (AML) in patients = 18 years of age
Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]

Registration Number: CTIS2023-509019-97-00

Lead Sponsor: Karolinska University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 69

Inclusion Criteria

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.

Exclusion Criteria

Acute promyelocytic leukemia., Patients with a history of non-compliance to medical regimens or who are considered unreliable with respect to compliance., 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 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