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
Key facts
- Where
- Falun, Gothenburg, Halmstad, Huddinge, Linkoping, Lulea, Lund, Orebro, Skovde, Umea és Uppsala, SvédországSee the 11 sites
- Phase
- 1/2. fázis
Where in Svédország
- Region DalarnaFalun, SvédországNo longer taking part
- Sahlgrenska University Hospital-Vastra GotalandsregionenGothenburg, SvédországNo longer taking part
- Region HallandHalmstad, SvédországNo longer taking part
- Karolinska University HospitalHuddinge, SvédországNo longer taking part
- Linkoping University Hospital Region OstergotlandLinkoping, SvédországNo longer taking part
- Region NorrbottenLulea, SvédországNo longer taking part
- Region Skane Skanes UniversitetssjukhusLund, SvédországNo longer taking part
- Region Oerebro LaenOrebro, SvédországNo longer taking part
- Skaraborg Hospital-Vastra GotalandsregionenSkovde, SvédországNo longer taking part
- Region VaesterbottenUmea, SvédországNo longer taking part
- Uppsala University HospitalUppsala, SvédországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Karolinska University Hospital
- Trial code
- EU 2023-509019-97-00
- Record updated
- 2024. március 18.
- Original description
To assess the safety and tolerability of HU at three different doselevels added to standard AML therapy consisting of ara-C and daunorubicin (frequency and severity of toxicities; dose-finding).Read full original descriptionShow less
HEAT-AML (Hydroxyurea-Enhanced Ara-C Treatment of Adult Acute Myeloid Leukaemia): A phase I/II multi-centre 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)
To assess the safety and tolerability of HU at three different doselevels added to standard AML therapy consisting of ara-C and daunorubicin (frequency and severity of toxicities; dose-finding).
To assess the effect of HU added to standard AML therapy consisting of ara-C and daunorubicin on the rate of negative minimal residual disease (MRD-negativity) after the second standard chemotherapy cycle
Inclusion: 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: Ongoing treatment with gemtuzumab-ozogamicin; Known intolerance to any of the chemotherapeutic drugs in the protocol; Patients with a history of non-compliance to medical regimens or who are considered unreliable with respect to compliance; 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; Acute promyelocytic leukemia; CNS leukaemia; Positive pregnancy test. Lactating female or female of childbearing potential not using adequate contraception; Fanconi anaemia.