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)

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509019-97-00

Enrollment

Registered

2024-03-18

Start date

2019-07-15

Completion date

Unknown

Last updated

2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newly diagnosed acute myeloid leukaemia (AML) in patients ≥ 18 years of age

Brief summary

MRD-negativity after cycle 2. Defined as malignant blasts as a percentage of total bonemarrow cells and as a percentage of the whole white blood cell compartment. These percentages are calculated based on the frequency of cells with an aberrant phenotype.

Detailed description

Safety and tolerability (frequency and severity of non-hematological toxicities)., Time to hematopoietic recovery (ANC 0.5 and 1.0 x 109/L; platelets 50 x 109/L) after each chemotherapy treatment cycle, defined as the time from the start of the cycle until recovery., Efficacy profile (response rate (CR, CRi, MLFS), event free survival (EFS), relapse-free survival (RFS), and overall survival (OS))

Interventions

DRUGHydroxycarbamide medac 500 mg capsule

DRUGhard

DRUGCytarabine STADA 20 mg/ml injektionsvätska

DRUGlösning

DRUGCerubidin 20 mg pulver till infusionsvätska

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
MRD-negativity after cycle 2. Defined as malignant blasts as a percentage of total bonemarrow cells and as a percentage of the whole white blood cell compartment. These percentages are calculated based on the frequency of cells with an aberrant phenotype.	—

Secondary

Measure	Time frame
Safety and tolerability (frequency and severity of non-hematological toxicities)., Time to hematopoietic recovery (ANC 0.5 and 1.0 x 109/L; platelets 50 x 109/L) after each chemotherapy treatment cycle, defined as the time from the start of the cycle until recovery., Efficacy profile (response rate (CR, CRi, MLFS), event free survival (EFS), relapse-free survival (RFS), and overall survival (OS))	—

Countries

Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026