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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
EU CTIS ID: 2023-509019-97-00
What this study is testing
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
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.