2023-509019-97-00Active, not recruitingPhase 1/2
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
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)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 18 Mar 2024
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 69 (estimated)
- First submitted
- 28 Feb 2024
- Start date
- 15 Jul 2019
- Lead sponsor
- Karolinska University Hospital
- Diseases
- Acute myeloid leukemia
- EU CT number
- 2023-509019-97-00
- EudraCT number
- 2018-004050-16
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 69
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Ongoing treatment with gemtuzumab-ozogamicin.
- Known intolerance to any of the chemotherapeutic drugs in the protocol.
Other illness
- 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.
Lab values
- 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
Other
- Acute promyelocytic leukemia.
- CNS leukaemia
- Positive pregnancy test. Lactating female or female of childbearing potential not using adequate contraception.
- Fanconi anaemia
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Region Dalarna | Falun | Sweden | Active, not recruiting |
| Sahlgrenska University Hospital-Vastra Gotalandsregionen | Gothenburg | Sweden | Active, not recruiting |
| Region Halland | Halmstad | Sweden | Active, not recruiting |
| Karolinska University Hospital | Huddinge | Sweden | Active, not recruiting |
| Linkoping University Hospital Region Ostergotland | Linkoping | Sweden | Active, not recruiting |
| Region Norrbotten | Lulea | Sweden | Active, not recruiting |
| Region Skane Skanes Universitetssjukhus | Lund | Sweden | Active, not recruiting |
| Region Oerebro Laen | Orebro | Sweden | Active, not recruiting |
| Skaraborg Hospital-Vastra Gotalandsregionen | Skovde | Sweden | Active, not recruiting |
| Region Vaesterbotten | Umea | Sweden | Active, not recruiting |
| Uppsala University Hospital | Uppsala | Sweden | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.