Hemostasis During Asparaginase Treatment in Acute Lymphoblastic Leukemia(ALL)

Aarhus University Hospital

Status: Completed

Conditions: Acute Lymphoblastic Leukemia

Study type: Observational

Funder types: Other

Identifiers

NCT01094392

Hemostasis-NOPHO

Details and patient eligibility

About

Asparaginase is an important drug in the treatment of childhood leukemia. One of the rare but severe side effects to the treatment is thrombosis in or outside the central nervous system.

The aim of this study is to investigate and describe the influence on the coagulation parameters during prolonged treatment with asparaginase.

Hopefully this knowledge will help to foresee the risk of thrombosis and thus making it possible to prevent these.

Enrollment: 65 patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Childhood ALL, eligible to receive standard risk or intermediate risk therapy as described in the protocol, written informed consent has been obtained

Exclusion criteria

• No allergic reactions to PEG-asparaginase

Trial design

65 participants in 2 patient groups

treatment every 6th week during 6 months

treatment every 2nd week during 6 months