Endothelial Activation Hemostasis Disturbances and Severe Bleeding Events in Hyperleukocytic Acute Myeloid Leukemia (HEAL)

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Leukemia, Myeloid, Acute

Study type: Observational

Funder types: Other

Identifiers

NCT04133220

190002

Details and patient eligibility

About

Hyper-leukocytosis > 50.109/L is observed in 15% of acute myeloid leukemia (AML).

Level of hyper-leukocytosis is linearly associated with the incidence of life threatening complications that lead to the early death in 25% of these patients.

The HEAL project is a prospective, uni-centric, observational study that plans to include a cohort of 50 patients presenting de novo AML with hyper-leukocytosis (HL) (> 50.109/L) and 10 controls. The aim of the study is to describe the relative proportion of various hemostasis components disturbances, endothelium alterations, platelet dysfunction and to calculate cumulative incidence of hemorrhagic and thrombotic complications as well as overall survival of patients presenting with HL AML.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• De novo AML
• GB counts > 50 G/L
• Eligible for intensive chemotherapy
• no previous AML treatment

Exclusion criteria

• secondary AML
• relapse of AML
• Acute promyelocytic leukemia
• Previous antiplatelet or anticoagulant treatment

Trial design

60 participants in 2 patient groups

Cases

Description:

Patients with acute myeloid leukemia, associated to hyper leukocytosis

Control

Description:

Patients with acute myeloid leukemia, without hyper leukocytosis