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; MedDRA version: 20.0 Level: HLT Classification code 10024291 Term: Leukaemias acute myeloid System Organ Class: 100000004851; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2018-004050-16-SE
• Lead Sponsor: niversity Hospital Karolinska

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-04
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 69

Inclusion Criteria

•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

Exclusion Criteria

•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified